%PDF-1.3 % 1 0 obj << /CreationDate (D:20051213125333-04'00') /ModDate (D:20051213125333-04'00') /Producer (Acrobat Distiller 5.0.5 for Macintosh) /Author (WendyS) /Title (GOV2013 Ambulatory Medicine) /Creator (QuarkXPress\(tm\) 5.01) >> endobj 2 0 obj << /Type /Metadata /Subtype /XML /Length 1064 >> stream GOV2013 Ambulatory Medicine endstream endobj 4 0 obj << /Length 506 >> stream 1 g /GS1 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F1 1 Tf 40 0 0 40 161.9023 566.6755 Tm /Cs8 cs 1 scn /GS2 gs -0.0001 Tc 0.0125 Tw (Prescription Drug)Tj -1.1789 -1.05 TD (Importation as a Policy)Tj -0.8454 -1.05 TD (Option to Lower the Cost of)Tj 0.7619 -1.05 TD (Medications in the U.S.)Tj 15.4 0 0 14 344.5214 96.9084 Tm -0.0151 Tc (American College of Physicians)Tj 4.6365 -1.1429 TD (A Policy Monograph)Tj 6.037 -1.1429 TD -0.015 Tc 0 Tw (2005)Tj ET Q endstream endobj 5 0 obj << /ProcSet [/PDF /Text ] /Font << /F1 6 0 R >> /ExtGState << /GS1 7 0 R /GS2 8 0 R >> /ColorSpace << /Cs8 9 0 R >> >> endobj 11 0 obj << /FunctionType 0 /Domain [0 1] /Range [0 1 0 1 0 1 0 1] /BitsPerSample 8 /Size [255] /Length 733 /Filter /FlateDecode >> stream H X|ٶm۶m/۶mcQk֬5jYs`A4B$<))A:iSBT' i cZ3,!kdK@g@rdDrfBrܙ_V$6@v/)) )FAJEJR2l\A|!XT\CG@j%ZھNin^YoPiXiTiTDVB救UЖUVu5Mum o_P X;AEn ОWCw#Oc 5G@-a~dtT[tt;t'vB'uF')]Щ]i~FwtftVOl؋07a^|/aa?"?aҁe~ ŠCꡄ5k#F6MG!l#OwM H3L?pJ84px:?:pl&, r6D™D\<켿0,®.Ʈ-/ŞX=oZ=Y={n a-: ث6a76conooن{Ͽ`'.#n얿d?A_>B([1ljwN> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F5 1 Tf 12 0 0 12 304.333 47.019 Tm 0 0 0 1 k /GS2 gs 0 Tc 0 Tw (i)Tj /F1 1 Tf 26 0 0 26 121.2425 529.4999 Tm -0.0001 Tc 0.0125 Tw (Prescription Drug Importation as a)Tj 0.0704 -1.0769 TD (Policy Option to Lower the Cost of)Tj 2.1708 -1.0769 TD (Medications in the U.S.)Tj /F3 1 Tf 18 0 0 18 203.4677 406.5 Tm -0.0105 Tc 0.0129 Tw (A Policy Monograph of the)Tj -0.8742 -1.1111 TD (American College of Physicians)Tj 11 0 0 11 127 161.5 Tm -0.0151 Tc -0.0161 Tw [(This paper)59.7(, written by Rachel Groman, MPH, was developed by the Health and)]TJ 0 -1.0909 TD -0.0016 Tc 0.1256 Tw [(Public Policy Committee of the American College of Physicians: Jeffrey P)149.7(.)]TJ T* -0.0054 Tc 0.0948 Tw (Harris, MD, )Tj /F5 1 Tf 5.6975 0 TD -0.0053 Tc 0 Tw (Chair)Tj /F3 1 Tf 2.2888 0 TD -0.0054 Tc 0.0948 Tw (; David L. Bronson, MD, )Tj /F5 1 Tf 11.3056 0 TD -0.0053 Tc 0 Tw (Co-Chair)Tj /F3 1 Tf 3.718 0 TD 0.0948 Tw (; CPT Julie Ake, MC,)Tj -23.0099 -1.0909 TD 0.0851 Tw [(USA; Patricia P)149.8(.)0.1( Barry)79.8(, MD; Molly Cooke, MD; Herbert S. Diamond, MD;)]TJ T* 0.0185 Tw [(Joel S. Levine, MD; Mark E. Mayer)59.8(, MD; Thomas McGinn, MD; Robert M.)]TJ T* 0.0997 Tw [(McLean, MD; Ashley E. Starkweather)59.8(, MD; and Frederick E. T)139.8(u)0.1(rton, MD. )]TJ T* -0.0054 Tc 0.013 Tw (It was approved by the Board of Regents on 28 October 2005. )Tj ET Q endstream endobj 14 0 obj << /ProcSet [/PDF /Text ] /Font << /F1 6 0 R /F3 15 0 R /F5 16 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 19 0 obj << /Length 1918 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F5 1 Tf 12 0 0 12 302.666 47.019 Tm 0 0 0 1 k /GS2 gs -0.0003 Tc 0 Tw (ii)Tj /F3 1 Tf 11 0 0 11 116 303.1365 Tm -0.0054 Tc 0.013 Tw (How to cite this paper:)Tj 10 0 0 10 117.5 279.1365 Tm 0.0044 Tc 0.1248 Tw (American College of Physicians. Prescription Drug Importation as a Policy Option to)Tj 0 -1.2 TD -0.0002 Tc 0.0126 Tw [(Lower the Cost of Medications in the U.S. Philadelphia: American College of Physicians;)]TJ T* 0.0206 Tc 0.1718 Tw [(2005: Policy Monograph. \(A)39.7(vailable from American College of Physicians, 190 N.)]TJ T* -0.0002 Tc 0.013 Tw [(Independence Mall W)89.7(est, Philadelphia, P)74.8(A)0( 19106.\) )]TJ 0 -2.4 TD (Copyright \(c\) 2005 American College of Physicians. )Tj T* -0.024 Tc -0.0176 Tw (All rights reserved. Individuals may photocopy all or parts of Policy Mongraphs for educational,)Tj 0 -1.2 TD -0.0157 Tc -0.0207 Tw [(not-for)34.8(-profit uses. These papers may not be reproduced for commercial, for)34.8(-profit use in any)]TJ T* -0.0105 Tw (form, by any means \(electronic, mechanical, xerographic, or other\) or held in any information)Tj T* 0.0129 Tw [(storage or retrieval system without the written permission of the publisher)59.8(. )]TJ 0 -2.4 TD -0.002 Tc -0.024 Tw [(For questions about the content of this Policy Monograph, please contact ACP)149.6(, Division of)]TJ 0 -1.2 TD 0.0187 Tc 0.1105 Tw [(Governmental Affairs and Public Policy)79.7(, Suite 800, 2011 Pennsylvania A)39.7(venue NW)109.7(,)]TJ T* 0 Tc 0 Tw (W)Tj 1.0337 0 TD 0.0206 Tc 0.242 Tw [(ashington, DC 20006; telephone 202-261-4500. T)179.8(o)0( order copies of this Policy)]TJ -1.0337 -1.2 TD 0.2344 Tw (Monograph, contact ACP Customer Service at 800-523-1546, extension 2600, or )Tj T* -0.0002 Tc 0 Tw (215-351-2600.)Tj ET 0 0 0 1 K 0 J 0 j 1 w 10 M []0 d 90.5 323.5 431 -251 re 179.744 87.136 m S Q endstream endobj 20 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 22 0 obj << /Length 3387 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F7 1 Tf 14 0 0 14 91 708.9512 Tm 0 0 0 1 k /GS2 gs -0.0001 Tc 0.0139 Tw [(Ex)9.7(ecutive Summar)-9.9(y)]TJ /F3 1 Tf 11 0 0 11 127 679.7358 Tm -0.0053 Tc 0.0985 Tw [(In 2004, four competing proposals to legalize prescription drug importation)]TJ 0 -1.0909 TD 0.1054 Tw (were introduced in Congress. Although none were passed, similar proposals)Tj T* 0.1089 Tw (have been reintroduced in 2005. The Medicare Modernization Act \(MMA\),)Tj T* 0.0142 Tw (enacted in 2003, created the U.S. Department of Health and Human Services)Tj T* 0.0154 Tc 0.1254 Tw [(\(HHS\) T)159.7(ask Force on Drug Importation and mandated that it report to)]TJ T* -0.0109 Tc -0.0203 Tw (Congress on the safety of drug importation and included a provision that would)Tj T* 0.0028 Tc 0.1212 Tw (allow importation of drugs from Canada if the HHS Secretary certifies to)Tj T* 0.0154 Tc 0.115 Tw (Congress that such imports do not threaten the health and safety of the)Tj T* -0.0053 Tc 0.0409 Tw [(American public and do provide cost savings. However)59.8(, the Secretary has not)]TJ T* 0.0129 Tw (certified such a program. )Tj 1.6364 -1.0909 TD -0.0157 Tc 0.0429 Tw (As the debate continues at the federal level, several states have created pro-)Tj -1.6364 -1.0909 TD -0.0053 Tc 0.0262 Tw (grams in defiance of the U.S. Food and Drug Administration \(FDA\), steering)Tj T* 0.0709 Tw [(Americans to the W)89.8(eb sites of Canadian and European pharmacies that they)]TJ T* -0.0028 Tc 0.1268 Tw [(deem safe and reliable. In January 2004, the state of V)99.8(e)0.1(rmont brought suit)]TJ T* -0.0053 Tc 0.0622 Tw (against the Bush administration for failing to write regulations for legal drug)Tj T* 0.1062 Tw (importation, and attorney generals from 18 states requested that the federal)Tj T* 0.0186 Tw (government immediately allow states to become licensed wholesalers or allow)Tj T* -0.0113 Tc -0.0199 Tw (them to contract with licensed wholesalers to import medications from Canada. )Tj 1.6364 -1.0909 TD -0.0053 Tc 0.0564 Tw [(In light of this recent activity)79.8(, the American College of Physicians \(ACP\))]TJ -1.6364 -1.0909 TD 0.0042 Tw (feels it is necessary to further develop its position on prescription drug impor-)Tj T* 0.1208 Tw (tation. A more comprehensive ACP position on this issue is needed for the)Tj T* -0.0139 Tc -0.0173 Tw (College to respond to patients needs in obtaining affordable prescription drugs.)Tj T* -0.0053 Tc 0.0907 Tw [(Furthermore, the College will be better prepared to respond to federal pro-)]TJ T* 0.0127 Tw (posals, which are quickly gaining traction, and state actions, which are already)Tj T* -0.0067 Tc -0.0245 Tw [(under way)79.7(. It is important that ACP continue to educate its members about the)]TJ T* 0.0086 Tc 0.1154 Tw (risks and benefits associated with drug imports, continue to review newly)Tj T* -0.0157 Tc 0.01 Tw [(reported evidence related to risks and safety)79.7(, and revise its position on the safet)-10.2(y)]TJ T* 0.0049 Tc 0.1191 Tw [(and effectiveness of drug importation as is necessary)79.7(.)0( This paper does not)]TJ T* -0.0053 Tc 0.1093 Tw [(attempt to critique the pharmaceutical industry)109.8(s)0( pricing practices or dictate)]TJ T* 0.0129 Tw (how the industry should be paid. )Tj /F5 1 Tf 12 0 0 12 302.5695 44.1436 Tm 0 Tc 0 Tw (1)Tj ET Q endstream endobj 23 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F7 24 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 26 0 obj << /Length 5352 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 69.9869 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj /F7 1 Tf 14 0 0 14 91 708.9512 Tm 0 Tw [(Bac)19.6(kgr)19.6(ound)]TJ /F3 1 Tf 11 0 0 11 127 690.9512 Tm -0.0053 Tc 0.0025 Tw [(Although the terms are used interchangeably)79.7(, importation typically refers to)]TJ 0 -1.0909 TD 0.0565 Tw [(drugs produced abroad and brought into the United States. Reimportation)]TJ T* 0.0692 Tw (refers to drugs produced in the U.S. and exported for sale abroad, then later)Tj T* -0.0212 Tw [(returned to the U.S. For purposes of this paper)59.8(, the terms reimportation and)]TJ T* 0.118 Tw (importation are used interchangeably since the proposals currently before)Tj T* -0.0057 Tc -0.0255 Tw (Congress do not distinguish between the terms in regard to the safeguards that)Tj T* -0.0053 Tc 0.0129 Tw (would be required before the drugs could be brought back to the U.S.)Tj 1.6364 -1.0909 TD 0.0535 Tw (Federal law strictly regulates the importation of pharmaceuticals through)Tj -1.6364 -1.0909 TD -0.0131 Tw [(the Federal Food, Drug, and Cosmetic \(FD&C\) Act. Currently)79.7(, the only types)]TJ T* 0.0342 Tw (of legally imported drugs are 1\) those that are manufactured in foreign FDA-)Tj T* 0.0133 Tw (inspected facilities and the subject of an FDA-approved drug application or 2\))Tj T* 0.0042 Tc 0.1198 Tw (those that are U.S.-approved and manufactured in the United States, sent)Tj T* -0.0053 Tc 0.0399 Tw [(abroad, then re-imported to the U.S. by the manufacturer under proper con-)]TJ T* -0.0005 Tw (trols and in compliance with FD&C Act requirements. All imported drugs are)Tj T* 0.0957 Tw [(required to meet the same standards as domestic drugs and, thus, cannot be)]TJ T* -0.0017 Tc 0.1257 Tw (unapproved, misbranded, or adulterated. This prohibition extends to drugs)Tj T* -0.0053 Tc 0.1144 Tw (that are foreign versions of U.S.-approved medications and drugs dispensed)Tj T* 0.0129 Tw (without a prescription \(1\).)Tj 1.6364 -1.0909 TD 0.019 Tw (In the 1980s, two separate policies emerged relating to the importation of)Tj -1.6364 -1.0909 TD 0.0129 Tw (prescription drugs amidst concerns over quality and safety:)Tj 2.1818 -2.1818 TD -0.0002 Tc 0.0401 Tw [( )-273.4(Commercial imports: The Prescription Drug Marketing Act of 1987)]TJ 1.0909 -1.0909 TD 0.0047 Tc 0.1245 Tw [(established today)109.7(s closed system of distribution, which prohibits)]TJ T* 0.0206 Tc 0.1389 Tw (anyone other than the original manufacturer from importing an)Tj T* -0.0002 Tc 0.0972 Tw (approved drug that was manufactured in the U.S. and then shipped)Tj T* 0 Tw (overseas. )Tj -1.0909 -1.0909 TD 0.066 Tw [( )-247.5(Personal use imports: The FDA exercises its enforcement discretion)]TJ 1.0909 -1.0909 TD -0.0023 Tc -0.0237 Tw (under certain circumstances and does not stop individuals with serious)Tj T* 0.0083 Tc 0.1209 Tw (conditions from bringing treatments into the U.S. that are legally)Tj T* 0.0007 Tc 0.1285 Tw (available in foreign countries but are not approved in the U.S. \(1\).)Tj T* -0.0061 Tc -0.0199 Tw [(This lenient personal use policy)79.6(, which permits individuals to import)]TJ T* -0.0244 Tc -0.0172 Tw (a 90-day supply of nonFDA-approved prescription drugs, was developed)Tj T* -0.0105 Tc 0.0556 Tw [(out of concern that certain AIDS treatments were not avail)]TJ 24.7372 0 TD -0.0002 Tc 0.0557 Tw (able in the)Tj -24.7372 -1.0909 TD 0.1005 Tw (U.S. \(2\). The policy was never intended to be a way for patients to )Tj T* 0.0161 Tc 0.1131 Tw [(purchase lower)34.7(-priced drugs in foreign countries, although it has)]TJ T* -0.0002 Tc 0.013 Tw (resulted in such. )Tj -1.6364 -2.1818 TD -0.0053 Tc 0.0672 Tw (In 1992, the Prescription Drug User Fee Act was passed to speed up the)Tj -1.6364 -1.0909 TD 0.0186 Tw (lengthy review process of new drug applications. As new drugs began to enter)Tj T* 0.0331 Tw [(the market quickly)79.8(, expenditures for drugs in the U.S. began to climb, in part)]TJ T* -0.0217 Tw (as a result of greater use of newer treatments, which are often more costly than)Tj T* 0.1021 Tw (older medicines. Meanwhile, drug prices abroad remained low as a result of )Tj T* -0.0182 Tw (centralized negotiations. In response to mounting political pressures, concerns)Tj T* 0.0747 Tw (over rising drug costs, and growing international price differences, Congress)Tj T* 0.1165 Tw (passed the Medicine Equity and Drug Safety Act of 2000 \(the MEDS Act\),)Tj T* 0.0004 Tc 0.1236 Tw (which created a 5-year program to allow imports by pharmacists and drug)Tj T* -0.0053 Tc -0.0244 Tw (wholesalers, although drugs could be imported only from specific countries. In)Tj T* 0.0044 Tw (order for this to take place, the Secretary of HHS had to certify that imported)Tj T* 0.0219 Tw [(drugs posed no additional risk to the public)109.9(s health and safety and resulted in)]TJ T* -0.0009 Tc 0.1249 Tw [(a significant reduction in cost. However)59.7(, neither the Clinton nor the Bush)]TJ T* -0.0053 Tc -0.0135 Tw (administration certified the safety of importation, thus preventing importation)Tj T* 0.0129 Tw (by wholesalers and pharmacists. )Tj /F5 1 Tf 12 0 0 12 302.8872 44.1436 Tm 0 Tc 0 Tw (2)Tj ET Q endstream endobj 27 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F7 24 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 29 0 obj << /Length 5036 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 171.6172 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj 11 0 0 11 145 710.6533 Tm -0.0053 Tc -0.0135 Tw (In 2003, Congress passed the Medicare Modernization Act \(MMA\), which)Tj -1.6364 -1.0909 TD -0.0156 Tc -0.0156 Tw (included an importation provision similar to the MEDS Act. The provision pro-)Tj T* -0.0053 Tc 0.0618 Tw [(vides authority for pharmacists and wholesalers to import certain drugs from)]TJ T* 0.0435 Tw [(Canada, subject to certain conditions. It also directs the Secretary of HHS to)]TJ T* 0.0282 Tw (grant waivers to permit importation of a 90-day supply of any FDA-approved)Tj T* 0.0952 Tw (prescription drug from a licensed Canadian pharmacy for personal use. The)Tj T* 0.0298 Tw (MMA provision differs from the MEDS Act in that it 1\) directs the Secretary)Tj T* 0.0034 Tw (to allow imports from Canada only \(the MEDS Act had allowed imports from)Tj T* -0.0142 Tw (a specific list of industrialized countries, including Canada\); 2\) codifies the dis-)Tj T* 0.001 Tw (cretion in enforcement that the FDA has exercised to allow the personal use)Tj T* 0.0806 Tw (imports of prescription drugs; 3\) prohibits manufacturers from entering into)Tj T* 0.1195 Tw (agreements to prevent the sale or distribution of imported products; and 4\))Tj T* -0.0104 Tc -0.0208 Tw [(includes a mechanism, based on evidence, by which the Secretary can terminate)]TJ T* -0.0053 Tc 0.0441 Tw [(the import program \(2\). However)59.8(, similar to the MEDS Act, for any of these)]TJ T* 0.049 Tw [(provisions to take effect, the Secretary of HHS must certify to Congress that)]TJ T* 0.0009 Tw (such imports do not threaten the health and safety of the American public and)Tj T* 0.0129 Tw (do provide cost savings. )Tj /F7 1 Tf 14 0 0 14 91 488.6533 Tm -0.0001 Tc 0 Tw (Scope)Tj /F3 1 Tf 11 0 0 11 127 470.6533 Tm -0.0053 Tc 0.0079 Tw (Imported drugs continue to enter the U.S. from all corners of the globe, from)Tj T* 0.0661 Tw (both developed and developing countries. In 2003, Americans imported $1.4)Tj T* -0.0144 Tw [(billion in prescription drugs. Of this total, an estimated two million Americans)]TJ T* -0.0054 Tc -0.004 Tw (purchased about 12 million prescription drug products with a value of approx-)Tj T* 0.013 Tw (imately $700 million from Canada \(1\).)Tj /F8 1 Tf 0 -2.1818 TD -0.0001 Tc 0.0138 Tw (Current Congressional Action)Tj /F3 1 Tf T* 0 Tc 0 Tw (S)Tj 0.5507 0 TD -0.0157 Tc -0.0072 Tw (ince 2003, legislation has been introduced to accelerate the legalization of drug)Tj -0.5507 -1.0909 TD 0.1119 Tw (importation. In the 108th Congress, four major proposals were introduced to)Tj T* 0.0791 Tw (legalize the importation of prescription drugs. The House passed one bill, but)Tj T* 0.0488 Tw (Senate leadership blocked efforts to hold hearings and floor action on a similar)Tj T* 0.0224 Tw (measure before the end of the session. In the 109th Congress, three viable drug)Tj T* 0.015 Tw (importation proposals have been introduced, all of which are similar to the pro-)Tj T* 0.0039 Tw (posals considered in the previous Congress. The three bills differ in the number)Tj T* -0.0094 Tc 0.123 Tw (of countries from which importation would be permitted, the time at which)Tj T* -0.0108 Tc 0.1244 Tw (importation could begin following enactment, and the extent of measures to)Tj T* -0.0157 Tc 0.0129 Tw [(ensure safety)79.7(. )]TJ 1.6364 -1.0909 TD -0.0045 Tw (Of these four proposals, the Pharmaceutical Market Access and Drug Safety)Tj -1.6364 -1.0909 TD -0.023 Tc -0.0186 Tw (Act of 2005 \(S 334/HR 700\), introduced by Senators Dorgan \(D-ND\) and Snowe)Tj T* -0.0237 Tc -0.0179 Tw (\(R-ME\) in the Senate and Representatives Emerson \(R-MO\) and Brown \(D-OH\))Tj T* -0.0157 Tc 0.039 Tw (in the House, is a leading vehicle for legislative action. Under the bill, pharma-)Tj T* 0.0455 Tw [(cies and wholesalers could import drugs from FDA-approved pharmacies in 25)]TJ T* -0.0187 Tc -0.0229 Tw (countriesincluding Canada, European Union nations, Australia, New Zealand,)Tj T* -0.0157 Tc 0.0292 Tw [(Japan, and Switzerlandwithin 1 year of the bill)109.7(s enactment. Individuals could)]TJ T* -0.0201 Tc -0.0215 Tw (also buy and import as much as a 90-day supply of prescription drugs for personal)Tj T* -0.0157 Tc 0.1174 Tw (use from registered Canadian pharmacies via mail-order or the Internet. The)Tj T* 0.0129 Tw (DorganSnowe bill includes a range of safety features, including: )Tj 2.1818 -2.1818 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc 0.0171 Tw (Requiring pharmacies and drug wholesalers to register with the FDA)Tj 0 -1.0909 TD 0.013 Tw (and be subject to frequent, random inspections. )Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc 0.013 Tw [(Limiting the number of licensed importers for the first 2 years.)]TJ /F5 1 Tf 12 0 0 12 302.5695 44.1436 Tm 0 Tc 0 Tw (3)Tj ET Q endstream endobj 30 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F7 24 0 R /F8 31 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 33 0 obj << /Length 5696 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 69.9869 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj 11 0 0 11 151 710.6533 Tm 0 Tc 0 Tw ()Tj 1.0909 0 TD 0.0056 Tc 0.1236 Tw (Allowing only the importation of FDA-approved medicines with a)Tj 0 -1.0909 TD -0.0002 Tc 0.0282 Tw [(chain of custody that can be traced back to an FDA-inspected manu-)]TJ T* 0.013 Tw (facturing plant. )Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc 0.0325 Tw [(Requiring that the FDA review notices of foreign versions of the top)]TJ 0 -1.0909 TD -0.0155 Tw (100 selling domestic FDA-approved drugs to determine whether they)Tj T* 0.013 Tw (are the same as their U.S. counterparts. )Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD 0.0018 Tc 0.1274 Tw (Allowing the use of anti-counterfeiting technology to identify safe,)Tj 0 -1.0909 TD -0.0002 Tc 0.013 Tw (legal imported medicines. )Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0007 Tc -0.0253 Tw (Requiring pharmacies and wholesalers to pay fees of as much as 1% of)Tj 0 -1.0909 TD 0.0081 Tc 0.1211 Tw (the price of the medications to fund the cost of additional federal)Tj T* -0.0002 Tc 0.0328 Tw [(inspectors and customs agents. These entities also would have to pay)]TJ T* 0.013 Tw (registration fees.)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0021 Tc -0.0239 Tw (Requiring frequent, random FDA inspection of Canadian pharmacies,)Tj 0 -1.0909 TD -0.0002 Tc 0.013 Tw (including those marketing their drugs via the Internet.)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc 0.1135 Tw [(Requiring that imported drugs be labeled in English and packed in)]TJ 0 -1.0909 TD -0.0001 Tc 0.0129 Tw [(tamper)34.8(-proof packages.)]TJ -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc 0.013 Tw (Establishing standards for Internet pharmacies.)Tj -1.6364 -2.1818 TD -0.0053 Tc 0.019 Tw (The DorganSnowe bill also includes a non-discrimination provision that)Tj -1.6364 -1.0909 TD 0.0459 Tw (would make it illegal for drug manufacturers to shut down the supply of pre-)Tj T* 0.105 Tw [(scription drugs to certain pharmacists and wholesalers, as they are currently)]TJ T* -0.0168 Tw (doing in Canada. In the previous Congress, the bill had bipartisan support, the)Tj T* -0.0121 Tc -0.0191 Tw (backing of 24 organizations, including American Association of Retired Persons)Tj T* 0.0154 Tc 0.4886 Tw (\(AARP\) and American Federation of LaborCongress of Industrial)Tj T* -0.0053 Tc 0.0129 Tw [(Organizations \(AFL-CIO\), and the support of a former FDA commissioner)59.8(. )]TJ 1.6364 -1.0909 TD 0.096 Tw (The other proposals currently in Congress differ in their safety require-)Tj -1.6364 -1.0909 TD -0.0076 Tc -0.0236 Tw (ments. For instance, the Pharmaceutical Market Access Act of 2005 \(S 109/HR)Tj T* 0.0087 Tc 0.1153 Tw [(328\), introduced by Senator V)49.7(itter \(R-LA\) and Representative Gutknecht)]TJ T* -0.0053 Tc 0.1118 Tw (\(R-MN\), requires less frequent FDA inspections of importers and exporters)Tj T* 0.0507 Tw [(than the DorganSnowe bill. It does not limit importation to FDA-approved)]TJ T* 0.0002 Tc 0.1238 Tw [(products or require verification of the chain of custody)79.8(. Similarly)79.7(, the Safe)]TJ T* -0.0054 Tc -0.0123 Tw [(IMPOR)49.6(T Act of 2005 \(S 184/HR 753\), introduced by Senator Gregg \(R-NH\))]TJ T* -0.0053 Tc -0.0007 Tw (and Representative Bradley \(R-NH\), does not require inspections of commer-)Tj T* -0.0214 Tw (cial drug shipments, does not authorize inspection of all entities in the chain of)Tj T* -0.0045 Tc 0.1285 Tw [(custody)79.6(, does not require FDA inspection of Internet pharmacies, and only)]TJ T* -0.0053 Tc 0.0165 Tw (permits inspection of records if FDA has reason to believe that an imported)Tj T* 0.0072 Tw [(drug presents a risk to public health. The Safe IMPOR)49.9(T Act also does limit)]TJ T* 0.108 Tw [(importation to FDA-approved products and would proceed more cautiously)]TJ T* 0.0295 Tw (than the DorganSnowe bill by limiting drug importation only to Canada for)Tj T* -0.01 Tc -0.0212 Tw [(the first 3 years. However)59.6(, it does not include an analogous, non-discrimination)]TJ T* -0.0053 Tc 0.0171 Tw (provision to prevent drug companies from shutting off supplies to pharmacies)Tj T* 0.0129 Tw [(that sell to Americans. )]TJ 1.6364 -1.0909 TD -0.0039 Tc 0.1279 Tw [(Legislation aimed at more specific aspects of importation has also been)]TJ -1.6364 -1.0909 TD 0.0092 Tc 0.1148 Tw [(introduced in Congress this year)59.7(. For example, the R)14.8(yan Haight Internet)]TJ T* -0.0053 Tc 0.0964 Tw (Pharmacy Consumer Protection Act of 2005 \(S 399/HR 840\), sponsored by)Tj T* 0.0612 Tw (Senators Coleman \(R-MN\) and Feinstein \(D-CA\) and Representatives Davis)Tj T* 0.0166 Tw [(\(R-V)79.7(A\) and W)79.7(axman \(D-CA\), would strengthen standards governing Internet)]TJ T* 0.0438 Tw (pharmacies. It would prohibit Internet pharmacies from distributing drugs to)Tj T* -0.0114 Tc -0.0198 Tw (consumers with a prescription solely on the basis of an online questionnaire and)Tj T* -0.0053 Tc 0.1093 Tw [(would give state attorneys general the ability to shut down rogue W)89.7(eb sites)]TJ T* 0.0462 Tw (nationwide, rather than just in their individual jurisdictions. The Safe Online)Tj T* -0.0054 Tc 0.0332 Tw [(Drug Act of 2005 \(HR 1808\), introduced by Representatives W)79.7(alden \(R-OR\))]TJ T* -0.0053 Tc -0.0235 Tw (and Davis \(D-FL\), would create a uniform certification standard to ensure that)Tj /F5 1 Tf 12 0 0 12 302.8872 44.1436 Tm 0 Tc 0 Tw (4)Tj ET Q endstream endobj 34 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 36 0 obj << /Length 5392 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 171.6172 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj 11 0 0 11 127 710.6533 Tm -0.0092 Tc -0.022 Tw (all U.S.-based Internet pharmacies meet rigorous FDA standards and adhere to)Tj 0 -1.0909 TD 0.0003 Tc 0.1237 Tw [(state regulations for operating a pharmacy)79.6(. At present, safety standards for)]TJ T* -0.0053 Tc 0.0129 Tw [(Internet pharmacies are voluntary)79.8(.)]TJ /F8 1 Tf 0 -2.1818 TD -0.0002 Tc 0.0139 Tw [(MMA Stud)14.7(y)]TJ /F3 1 Tf T* -0.0053 Tc -0.0006 Tw (The MMA mandated that a task force be formed to report to Congress on the)Tj 0 -1.0909 TD 0.0154 Tc 0.1138 Tw [(safety of drug importation. The HHS T)159.8(ask Force on Drug Importation,)]TJ T* -0.0047 Tc 0.1288 Tw (appointed by HHS Secretary Thompson, conducted six listening sessions)Tj T* 0.0154 Tc 0.1204 Tw (where members heard from consumer advocates, health care purchasers,)Tj T* -0.0053 Tc 0.0037 Tw (providers, health care industry representatives, international stakeholders, and)Tj T* -0.0054 Tc 0.013 Tw (the public. )Tj 1.6364 -1.0909 TD -0.0157 Tc -0.0164 Tw [(In December 2004, the HHS T)159.8(ask Force on Drug Importation issued a final)]TJ -1.6364 -1.0909 TD 0.0766 Tw (report, concluding that drug importation would be costly to implement; could)Tj T* 0.076 Tw (slow research and development of new drugs; and, if not restricted to Canada,)Tj T* -0.0214 Tc -0.0202 Tw (could be dangerous to consumers \(3\). The report also concluded that importation)Tj T* 0.005 Tc 0.1827 Tw (would provide little savings overall, claiming that while wholesalersthe )Tj T* -0.0157 Tc 0.1247 Tw [(middlemen in drug importationstand to gain the most from legal)]TJ 28.5005 0 TD -0.0053 Tc (ized drug)Tj -28.5005 -1.0909 TD 0.0316 Tw (importation, consumer savings would be modest after taking into account the)Tj T* -0.0054 Tc 0.013 Tw (cost of liability suits. )Tj 1.6364 -1.0909 TD -0.0157 Tc 0.089 Tw (In a letter accompanying the report, the Secretaries of HHS and the U.S.)Tj -1.6364 -1.0909 TD 0.0094 Tw (Department of Commerce outlined the conditions under which the administra-)Tj T* 0.1159 Tw (tion would support drug importation. The letter stated that commercial drug)Tj T* -0.0148 Tc 0.1284 Tw (importation should involve high-volume, high-cost prescription drugs from a)Tj T* -0.0157 Tc 0.0663 Tw (country with comparable drug safety standards, noting that Canada is the only)Tj T* -0.0184 Tc -0.0232 Tw (country from which importation should be considered at this point. According to)Tj T* -0.018 Tc -0.0236 Tw [(the letter)59.6(, only commercial importation from licensed foreign wholesalers should)]TJ T* -0.0157 Tc 0.0428 Tw (be permitted, while personal importation through the mail should be excluded.)Tj T* 0.0101 Tw (Other safeguards, such as labeling requirements and inspection procedures, also)Tj T* 0.0129 Tw (were outlined in the letter \(4\).)Tj /F8 1 Tf 0 -2.1818 TD -0.0001 Tc 0.0138 Tw (Recent State Action )Tj /F3 1 Tf T* -0.0157 Tc 0.069 Tw (As constituents become increasingly frustrated with the high cost of drugs and)Tj 0 -1.0909 TD -0.0198 Tc -0.0218 Tw (with Congressional inaction on the issue of importation, more and more pressure)Tj T* -0.0157 Tc 0.0963 Tw (is being placed on state and local officials. In 2004, attorney generals from 18)Tj T* -0.0167 Tc -0.0249 Tw (states sent a letter requesting that the Secretary of HHS immediately allow states)Tj T* -0.0157 Tc 0.0558 Tw (to become licensed wholesalers or allow them to contract with licensed whole-)Tj T* 0.0755 Tw [(salers to import medications from Canada. Throughout the year)59.7(, governors of)]TJ T* 0.0004 Tc 0.1132 Tw [(Iowa, Illinois, Minnesota, New Hampshire, and W)29.7(isconsin approached the)]TJ T* -0.0157 Tc 0.0324 Tw [(administration seeking, at minimum, a waiver to conduct pilot programs to test)]TJ T* -0.0201 Tw (ways to safely import medications. The FDA has remained steadfast in its refusal)Tj T* -0.0161 Tc -0.0255 Tw (to consider such arrangements, despite an agreement from the states to allow the)Tj T* -0.0157 Tc -0.0195 Tw [(FDA to shut down a pilot if any violations were found. In August 2004, V)99.7(e)0.1(rmont)]TJ T* 0.0203 Tw (state officials went so far as to file suit against the FDA when the agency denied)Tj T* 0.0129 Tw [(the state)109.7(s request for a waiver to authorize a drug importation pilot project. )]TJ 1.6364 -1.0909 TD -0.0053 Tc -0.0199 Tw [(The lack of consensus in Congress to address importation has pushed state)]TJ -1.6364 -1.0909 TD -0.0187 Tw (and municipalities to enact their own importation programs. In 2004, 28 states)Tj T* 0.0154 Tc 0.1179 Tw (and the District of Columbia considered drug importation measures \(5\).)Tj T* -0.0053 Tc 0.1031 Tw [(Minnesota, which currently has the largest government-sponsored program,)]TJ T* 0.0094 Tw [(launched the first W)89.8(eb site in the nationRxConnect.comlinking residents)]TJ T* -0.0039 Tc 0.1279 Tw (to Canadian mail-order pharmacies that meet state established standards of)Tj T* -0.0157 Tc 0.0342 Tw [(safety)79.7(. Illinois, W)29.6(isconsin, Missouri, Kansas, and V)99.7(e)0.1(rmont have joined togethe)-10.3(r)]TJ /F5 1 Tf 12 0 0 12 302.5695 44.1436 Tm 0 Tc 0 Tw (5)Tj ET Q endstream endobj 37 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F8 31 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 39 0 obj << /Length 5917 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 69.9869 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj 11 0 0 11 127 710.6533 Tm -0.0053 Tc 0.0019 Tw (under the I-SaveRx.net program, under which states contract with a Canadian)Tj 0 -1.0909 TD 0.0462 Tw (pharmacy benefit manager that connects residents with a clearinghouse of 45)Tj T* -0.01 Tc -0.0212 Tw (pharmacies and prescription drug wholesalers in Canada, the United Kingdom,)Tj T* -0.0053 Tc -0.0155 Tw [(and Ireland. Health insurance plans are required to provide coverage for drugs)]TJ T* -0.0117 Tw [(purchased through the program on the same terms and conditions as prescrip-)]TJ T* -0.0101 Tc -0.0211 Tw (tion drugs purchased in the U.S. About 1,900 residents enrolled in the program)Tj T* -0.0053 Tc 0.0328 Tw [(in the first 3 months \(6\). The state of New Hampshire introduced a W)89.7(eb site)]TJ T* 0.0455 Tw (offering residents information on ordering prescription drugs from Canadian)Tj T* 0.0241 Tw [(pharmacies, while Boston)109.8(s mayor launched a drug importation pilot program)]TJ T* -0.0049 Tc 0.1289 Tw [(for 14,000 city employees and retirees. V)99.7(arious other locales have launched)]TJ T* -0.0126 Tc -0.0186 Tw [(similar programs, including Springfield, Massachusetts; Montgomery)79.7(,)0( Alabama;)]TJ T* -0.0053 Tc 0.0129 Tw [(and Montgomery County)79.7(, Maryland. )]TJ 1.6364 -1.0909 TD -0.0157 Tc 0.0715 Tw [(In January 2005, Rhode Island)109.7(s Department of Health was the first in the)]TJ -1.6364 -1.0909 TD 0.004 Tc 0.1097 Tw (nation to file regulations to allow residents to purchase prescription drugs )Tj T* -0.0157 Tc 0.1261 Tw (from Canada. The regulations give the Rhode Island Board of Pharmacy the)Tj T* -0.0153 Tc 0.129 Tw (authority to license Canadian pharmacies in the same manner that it licenses)Tj T* -0.0157 Tc 0.0478 Tw (other out-of-state mail-order pharmacies \(5\). The pharmacies must be licensed)Tj T* 0.0041 Tw (by regulators where they are based, and Rhode Island regulators retain the right)Tj T* 0.0008 Tc 0.1129 Tw [(to inspect the Canadian locations if necessary)79.8(. The regulations also specify )]TJ T* -0.0157 Tc 0.052 Tw (minimum staffing and safety requirements at the pharmacies. Residents can fill)Tj T* 0.1014 Tw (prescriptions from the Canadian pharmacies by using the Internet, telephone, )Tj T* -0.0094 Tc 0.1231 Tw (or other methods and receive the medications through the mail or a private )Tj T* -0.0157 Tc 0.0129 Tw (delivery service \(7\). )Tj 1.6364 -1.0909 TD -0.0139 Tc -0.0173 Tw [(The FDA has, for the most part, refrained from taking formal action against)]TJ -1.6364 -1.0909 TD -0.0125 Tc -0.0187 Tw (states and municipalities that have instituted such programs. Instead, the agency)Tj T* -0.0052 Tc 0.1293 Tw (has sent letters to those entities advising them of the safety risks associated)Tj T* 0.0104 Tw (with importing medicines. The FDA has also warned that such programs may)Tj T* 0.0573 Tw (violate federal law and that states could face tort liability suits and charges of)Tj T* 0.0129 Tw (assisting in criminal activity if individuals suffer injury from these drugs. )Tj 1.6364 -1.0909 TD 0.0025 Tc 0.1112 Tw [(In a few cases, however)59.6(, the federal government has acted with tighter)]TJ -1.6364 -1.0909 TD -0.0157 Tc -0.0248 Tw (enforcement. In 2003, the U.S. Department of Justice filed a lawsuit on behalf of)Tj T* 0.0888 Tw (the FDA against two sister companies, Rx Depot Canada LLC and Rx Depot)Tj T* 0.0143 Tw [(Inc., that enabled U.S. residents to purchase lower)34.8(-cost prescription drugs from)]TJ T* -0.018 Tw (Canada. The government claimed that the storefront pharmacy violated a feder-)Tj T* -0.0261 Tc -0.0155 Tw (al law that allows only prescription drug manufacturers to import medications into)Tj T* -0.0157 Tc 0.1138 Tw (the U.S. In December 2004, the FDA obtained an injunction prohibiting the)Tj T* -0.0201 Tc -0.0215 Tw (company from importing prescription drugs and requiring the company to tell its)Tj T* -0.0157 Tc 0.0643 Tw (customers that its drug import business violates the law \(8\). The FDA has also)Tj T* 0.0054 Tw [(threatened to take the state of Illinois to court for initiating its drug import pro-)]TJ T* -0.0078 Tw (gram, which is increasingly gaining the support and participation of other states. )Tj 1.6364 -1.0909 TD 0.0838 Tw (In response to growing concerns about the adequacy of supply in Canada,)Tj -1.6364 -1.0909 TD 0.0575 Tw (given rapidly growing and illegal trade through Canadian Internet pharmacies,)Tj T* -0.026 Tc -0.0156 Tw (many pharmaceutical companies established supply integrity programs. In January)Tj T* -0.0157 Tc [(2005, Merck & Co., the second largest U.S. drug maker)59.7(, began shutting off sales)]TJ T* -0.0227 Tc -0.0189 Tw [(to Canadian pharmacies exporting drugs to American patients. Merck became the)]TJ T* -0.0157 Tc -0.023 Tw (fourth drug maker to take such a step, joining Pfizer Inc., AstraZeneca PLC, and)Tj T* 0 Tc 0 Tw (W)Tj 1.0274 0 TD -0.0157 Tc 0.0535 Tw (yeth. In reaction, consumer groups have filed lawsuits against these pharma-)Tj -1.0274 -1.0909 TD -0.0046 Tw [(ceutical companies, claiming that they are violating antitrust and consumer)34.8(-pro-)]TJ T* 0.0253 Tw (tection laws by reducing supplies to Canadian pharmacies that sell medicines to)Tj T* -0.0138 Tc 0.1274 Tw [(Americans. Minnesota)109.7(s governor is now considering importation agreements)]TJ T* -0.0004 Tc 0.1141 Tw (with countries in Europe and elsewhere because pharmaceutical companies)Tj T* -0.0157 Tc 0.004 Tw [(threatened to end supplies of their products to Canadian online pharmacies tha)-10.1(t)]TJ T* -0.0053 Tc 0.0129 Tw (sell to Minnesota residents. )Tj /F5 1 Tf 12 0 0 12 302.8872 44.1436 Tm 0 Tc 0 Tw (6)Tj ET Q endstream endobj 40 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 42 0 obj << /Length 5827 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 171.6172 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj /F5 1 Tf 12 0 0 12 302.5695 44.1436 Tm 0 Tc 0 Tw (7)Tj /F8 1 Tf 11 0 0 11 127 711.1045 Tm -0.0001 Tc 0.0138 Tw (Response of Canadian Officials )Tj /F3 1 Tf 0 -2.1818 TD -0.0239 Tc -0.0229 Tw (In June 2005, the Canadian Health Minister announced that he plans to introduce)Tj 0 -1.0909 TD -0.0209 Tc 0.0244 Tw (legislation that would allow for the temporary ban of bulk exports when supplies)Tj T* -0.023 Tc -0.0238 Tw (are running low at home. He also intends to establish a drug supply network with-)Tj T* -0.0209 Tc 0.0359 Tw (in the federal ministry Health Canada and work with provinces and pharmaceu-)Tj T* -0.0202 Tc 0.1287 Tw [(tical companies to provide more comprehensive data on Canada)109.8(s prescription)]TJ T* -0.0209 Tc 0.0419 Tw [(drug supply)79.7(. The Canadian Health Minister has continually warned that impor-)]TJ T* -0.0232 Tc -0.0236 Tw [(tation by the U.S. is cutting into Canada)109.6(s ability to adequately supply medications)]TJ T* -0.0209 Tc 0.051 Tw (to its citizens. Although no shortage currently exists, Canadian officials are con-)Tj T* -0.025 Tc -0.0218 Tw (cerned that if importation legislation is passed, Americans will flock to Canada and)Tj T* -0.006 Tc 0.1145 Tw (disrupt the supply chain in this much smaller nation. The Canadian Health)Tj T* -0.0177 Tc 0.1262 Tw (Minister previously suggested establishing a list of prescriptions on which the)Tj T* -0.0256 Tc -0.0212 Tw (Canadian government can restrict sales in the event of a shortage. He also has pro-)Tj T* -0.0209 Tc 0.0184 Tw (posed a crackdown on online pharmacies that sell prescription drugs to U.S. res-)Tj T* -0.0117 Tw (idents and proposed restrictions against Canadian physicians co-signing prescrip-)Tj T* -0.0297 Tc -0.0171 Tw (tions for U.S. residents who are not present and have not been examined. Although)Tj T* -0.0209 Tc 0.0553 Tw (there is no law against signing foreign prescriptions without seeing the patients,)Tj T* 0.0129 Tw (physician regulatory boards in Canada have ethics rules against the practice \(9\). )Tj 1.6364 -1.0909 TD -0.0157 Tc 0.0498 Tw (Advocacy groups for U.S. seniors have begun to examine proposals to pur-)Tj -1.6364 -1.0909 TD 0.0376 Tw (chase prescription drugs from European and Asian nations because of concerns)Tj T* -0.0152 Tw [(that the Canadian government might block the sale of lower)34.8(-cost medications to)]TJ T* -0.0209 Tc -0.0207 Tw (the U.S. While supporters maintain that the prescription drug regulatory systems)Tj T* -0.0169 Tc -0.0247 Tw (of European nations are as safe as those in the U.S., others cite the dangers of the)Tj T* -0.0157 Tc 0.1022 Tw (European system, which operates under parallel trade, where any European)Tj T* 0.0129 Tw [(country can import drugs from any other European country)79.7(.)0.3( )]TJ /F8 1 Tf 0 -2.1818 TD -0.0001 Tc 0.0138 Tw [(Priv)19.7(ate Sector)]TJ /F3 1 Tf T* -0.0052 Tc 0 Tw (As)Tj 1.0109 0 TD ( )Tj 0.247 0 TD -0.0209 Tc 0.0089 Tw (drug importation proposals are debated, the private sector continues to evalu-)Tj -1.2578 -1.0909 TD 0.0083 Tw (ate and develop strategies to ensure the safe distribution of prescription drugs. In)Tj T* -0.0137 Tc 0.1222 Tw (2005, the National Association of Boards of Pharmacy \(NABP\) launched the)Tj T* 0 Tc 0 Tw (V)Tj 0.6204 0 TD -0.0209 Tc -0.0163 Tw [(erified Accredited Wholesale Distributors \(V)79.8(A)74.8(WD\) program to accredit whole-)]TJ -0.6204 -1.0909 TD 0.0735 Tw (sale drug distributors. The program, which includes inspections paid for by the)Tj T* -0.0164 Tw [(wholesaler)59.7(, is designed to protect the public by preventing counterfeit drugs from)]TJ T* -0.0235 Tc -0.0233 Tw [(entering the U.S. drug supply)79.7(. The V)79.7(A)74.8(WD accreditation assures stakeholders that)]TJ T* -0.0182 Tc 0.1267 Tw (wholesaler distributors are legitimate, are qualified for state licensure, and are)Tj T* -0.0209 Tc 0.1074 Tw (using security and best practices for safely distributing prescription drugs. The )Tj T* -0.0052 Tc 0.1137 Tw [(program is similar to the NABP)109.7(s V)99.6(erified Internet Pharmacy Practice Sites)]TJ T* -0.025 Tc -0.0217 Tw (\(VIPPS\) program, which developed a certification process for Internet pharmacies)Tj T* -0.0209 Tc 0.0325 Tw [(in 1999. T)179.8(o)0( be VIPPS-certified, a pharmacy must comply with the licensing and)]TJ T* -0.0137 Tw (inspection requirements of their state and each state to which they dispense phar-)Tj T* 0.0059 Tw (maceuticals. Pharmacies must also comply with VIPPS criteria, including patient)Tj T* 0.0123 Tw [(rights to privacy)79.7(, authentication and security of prescription orders, adherence to)]TJ T* 0.0905 Tw [(a recognized quality assurance policy)79.7(, and provision of meaningful consultation)]TJ T* 0.0129 Tw (between patients and pharmacists. )Tj 1.6364 -1.0909 TD -0.0234 Tc -0.0234 Tw (The American Medical Association \(AMA\) recently endorsed the importation)Tj -1.6364 -1.0909 TD -0.0303 Tc -0.0165 Tw (of prescription drugs by wholesalers and pharmacies, provided that the medications)Tj T* -0.0297 Tc -0.0171 Tw [(are FDA-approved and are subject to reliable electronic tracking and that Congress)]TJ T* -0.0002 Tc 0.033 Tw (provides the FDA with the resources and authority to ensure that the supply)Tj T* -0.0103 Tc 0 Tw (is )Tj 0.8602 0 TD (r)Tj 0.3788 0 TD (eli)Tj 0.9881 0 TD -0.031 Tc -0.0157 Tw [(able. The AMA continues to oppose individual importation t)-15.5(h)-15.5(r)]TJ 24.6491 0 TD -0.0155 Tc (ough Internet)Tj -26.8763 -1.0909 TD -0.0053 Tc 0.0129 Tw (pharmacies until safety can be guaranteed. )Tj ET Q endstream endobj 43 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F8 31 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 45 0 obj << /Length 5319 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 69.9869 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj /F8 1 Tf 11 0 0 11 127 711.1045 Tm 0.0139 Tw [(Pub)9.6(lic Opinion)]TJ /F3 1 Tf 0 -2.1818 TD -0.0053 Tc -0.0123 Tw (A recent Kaiser Family Foundation survey found that 73% of Americans think)Tj 0 -1.0909 TD 0.0146 Tw (Congress should change the law to allow prescription drug importation. Only)Tj T* 0.0033 Tc 0.1207 Tw (21% oppose such measures. Sixty-nine percent said legalizing the practice)Tj T* -0.0179 Tc -0.0237 Tw [(would make medicines more affordable without sacrificing safety \(10\). A sepa)]TJ 30.9392 0 TD -0.0075 Tc 0 Tw (rate)Tj -30.9392 -1.0909 TD -0.0053 Tc 0.0443 Tw [(survey found that public support for drug importation decreased significantly)]TJ T* 0.0671 Tw (when respondents were asked about specific countries. Respondents were far)Tj T* 0.089 Tw (less likely to support importing medicines from European countries, such as)Tj T* -0.0155 Tc -0.0157 Tw (Greece, Portugal, and Spain \(40%\); European Union members, such as Estonia,)Tj T* -0.0053 Tc 0.1032 Tw (Latvia, and Malta \(31%\); or Asian countries, such as Japan \(42%\) than they)Tj T* 0.0129 Tw (were medicines from Canada \(69%\) \(11\).)Tj /F7 1 Tf 14 0 0 14 91 549.1045 Tm -0.0002 Tc 0.0139 Tw [(Ar)14.7(gument f)19.6(o)0(r Impor)-20(tation)]TJ /F8 1 Tf 11 0 0 11 127 519.1045 Tm (High Cost of Drugs)Tj /F3 1 Tf 0 -2.1818 TD -0.0157 Tc -0.0134 Tw (Both proponents and opponents of importation have stated that the larger prob-)Tj 0 -1.0909 TD 0.0035 Tw (lem at hand is the lack of affordability of prescription drugs. The importation of)Tj T* 0.0357 Tw (drugs is one of many strategies to reduce drug costs. It is well documented that)Tj T* 0.0112 Tw (American consumers, particularly the elderly and uninsured, often pay more for)Tj T* 0.0773 Tw (prescription drugs than do citizens in other countries. Americans pay up to an)Tj T* -0.0099 Tc 0.1236 Tw (estimated five times more to fill their prescriptions than consumers in other)Tj T* -0.0137 Tc 0.1274 Tw (countries. American seniors alone will spend $1.8 trillion on pharmaceuticals)Tj T* -0.0157 Tc 0.0129 Tw (over the next 10 years \(12\). )Tj 1.6364 -1.0909 TD -0.0209 Tc 0.0236 Tw [(Critics of the pharmaceutical industry cite that drug companies enjoy highe)-5.1(r)]TJ -1.6364 -1.0909 TD -0.0157 Tc 0.0408 Tw [(profits than any other industry year after year)59.7(. In 2002, for example, the top 10)]TJ T* 0.032 Tw (drug companies in the United States had a median profit margin of 17%, com-)Tj T* 0.0129 Tw (pared with only 3.1% for all the other industries on the )Tj /F5 1 Tf 22.8565 0 TD 0 Tw (Fortune )Tj /F3 1 Tf 3.2583 0 TD 0.013 Tw (500 list \(13\).)Tj -24.4785 -1.0909 TD 0.005 Tc 0.1305 Tw (Importation would not only give Americans access to more affordable )Tj -1.6364 -1.0909 TD -0.0157 Tc 0.0869 Tw (prescription drugs but would also increase competition among pharmaceutical)Tj T* 0.0895 Tw (companies, which could help drive down the prices of prescription drugs pro-)Tj T* 0.005 Tc 0.2163 Tw (duced in the U.S. An open pharmaceutical market could save American )Tj T* -0.0157 Tc 0.0129 Tw (consumers at least $38 billion each year \(14\). )Tj /F8 1 Tf 0 -2.1818 TD -0.0002 Tc 0.0139 Tw [(Ac)9.6(hie)14.7(ving Saf)9.6(ety)]TJ /F3 1 Tf T* -0.0053 Tc 0.1259 Tw [(Many prescription drugs that are commonly used by Americans are already)]TJ 0 -1.0909 TD -0.0146 Tc -0.0166 Tw (being manufactured abroad. About four in 10 prescription drugs now sold in the)Tj T* -0.0053 Tc 0.1042 Tw (U.S. are manufactured abroad, including most cholesterol-lowering medica-)Tj T* -0.025 Tw [(tions that are manufactured in Ireland, such as Lipitor \(Pfizer Inc.\). According)]TJ T* 0.0157 Tw [(to W)29.7(illiam Hubbard, associate commissioner of the FDA, the agency inspects)]TJ T* 0.0129 Tw (the part of the Irish plant that makes the pills sold in the U.S. \(15\). )Tj 1.6364 -1.0909 TD 0.0446 Tw [(Although a system has been created to ensure safety)79.7(, these inspections do)]TJ -1.6364 -1.0909 TD -0.0126 Tc -0.0186 Tw [(not always take place due to a lack of resources. The FDA is supposed to inspect)]TJ T* -0.0053 Tc 0.043 Tw [(each foreign drug manufacturer at least every other year)59.7(, but with only about)]TJ T* -0.0249 Tc -0.0167 Tw ($50 million each year to complete all drug inspections, both domestic and for)Tj 30.5286 0 TD -0.0145 Tc 0 Tw (eign,)Tj -30.5286 -1.0909 TD -0.0053 Tc 0.0129 Tw (the agency finds it impossible to fulfill this obligation \(15\). )Tj 1.6364 -1.0909 TD -0.0209 Tc 0.0084 Tw (Supporters, therefore, continue to advocate for strengthening and expanding)Tj -1.6364 -1.0909 TD -0.0123 Tw (the current regulatory system, including inspections of foreign production plants,)Tj T* -0.0168 Tw (licensing of wholesale importers, tracking of shipments from factories to pharma-)Tj T* -0.0286 Tc -0.0182 Tw [(cies, and the creation of an FDA W)89.7(eb site that lists approved pharmacies that could)]TJ T* -0.0209 Tc 0.0129 Tw (supply U.S. residents with safe prescription drugs from other nations.)Tj /F5 1 Tf 12 0 0 12 302.8872 44.1436 Tm 0 Tc 0 Tw (8)Tj ET Q endstream endobj 46 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F7 24 0 R /F8 31 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 50 0 obj << /Length 5194 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 171.6172 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj 11 0 0 11 145 710.6533 Tm 0 Tc 0 Tw (W)Tj 1.0578 0 TD -0.0053 Tc 0.0572 Tw [(ith an estimated two million Americans already importing prescription)]TJ -2.6942 -1.0909 TD 0.0074 Tc 0.1167 Tw (drugs without any safety mechanisms in place, proponents of importation )Tj T* -0.0053 Tc 0.0129 Tw [(continue to urge Congress to act to ensure the safety of these individuals.)]TJ /F8 1 Tf 0 -2.1818 TD -0.0001 Tc 0.0138 Tw [(State Suppor)-19.9(t)]TJ /F3 1 Tf T* 0 Tc 0 Tw (V)Tj 0.6359 0 TD -0.0053 Tc 0.1127 Tw [(arious state officials, including those from Minnesota, Iowa, V)99.8(e)0.1(rmont, and)]TJ -0.6359 -1.0909 TD 0.104 Tw [(North Dakota, have testified in support of importation. At a February 2005)]TJ T* -0.0108 Tc -0.0204 Tw [(hearing held by the Senate Health, Education, Labor)59.5(, and Pensions Committee)]TJ T* -0.0053 Tc 0.0737 Tw (\(HELP\), Minnesota Governor Pawlenty noted that safety concerns have not)Tj T* 0.0013 Tc 0.1227 Tw [(been a problem for his state)109.6(s drug importation program, RxConnect.com.)]TJ T* 0 Tc 0 Tw (W)Tj 1.0078 0 TD -0.0053 Tc -0.0045 Tw [(algreens and CVS Pharmacy)79.7(, the top two pharmacy chains in the U.S., have)]TJ -1.0078 -1.0909 TD 0.0122 Tw (also expressed support for importation on the condition that a safe channel be)Tj T* 0 Tw (established. )Tj /F8 1 Tf 0 -2.1818 TD -0.0002 Tc 0.0139 Tw [(Canada-Onl)14.7(y Appr)19.6(oac)9.6(h)]TJ /F3 1 Tf T* 0.0073 Tc 0.1219 Tw (Still others defend Canada-only importation proposals by attesting to the)Tj 0 -1.0909 TD -0.0027 Tc -0.0389 Tw [(securit)15.5(y)15.5( o)15.5(f)15.5( )]TJ 4.4929 0 TD -0.0182 Tc -0.0234 Tw (the Canadian system. The President of Ontario-based CanadaPharm,)Tj -4.4929 -1.0909 TD -0.0126 Tc 0.1263 Tw (a mail-order pharmacy that supplies Americans with prescription drugs from)Tj T* -0.0196 Tc -0.022 Tw [(Canada, has noted that Canada)109.6(s pharmaceutical approval and regulatory process,)]TJ T* -0.0177 Tc -0.0239 Tw (regulated through the Therapeutic Products Directorate, is equally as rigorous)Tj T* -0.0157 Tc -0.025 Tw [(as that of the FDA. He also pointed out that there is more opportunity inside the)]TJ T* -0.0148 Tc 0.1285 Tw (U.S. than in Canada for illicit drugs entering the drug distribution system.)Tj T* -0.0157 Tc 0.1059 Tw (Only five prescription drug wholesalers exist in Canada, in contrast to several)Tj T* -0.0056 Tc 0.1193 Tw (hundred in the U.S. Furthermore, medications are dispensed to pharmacies )Tj T* -0.0057 Tc 0.1194 Tw [(in manufacturer)34.8(-sealed packages, unlike in the U.S., where wholesalers may)]TJ T* -0.0157 Tc 0.0129 Tw (repackage them \(16\).)Tj /F7 1 Tf 14 0 0 14 91 356.6533 Tm -0.0002 Tc 0.0139 Tw [(Ar)14.7(gument a)9.6(gainst Impor)-20(tation)]TJ /F8 1 Tf 11 0 0 11 127 326.6533 Tm -0.0001 Tc [(Saf)9.7(ety Concerns)]TJ /F3 1 Tf 1.6364 -2.1818 TD -0.0054 Tc 0.1226 Tw [(The most vocal argument against prescription drug importation centers )]TJ -1.6364 -1.0909 TD -0.0121 Tc -0.0191 Tw [(on safety)82.9(.)-229.6(Opponents )-5.2(fear )]TJ 10.6685 0 TD -0.0101 Tc -0.0159 Tw (that foreign drugs may be improperly labeled, stored,)Tj -10.6685 -1.0909 TD -0.0002 Tc 0.004 Tw (and shipped. Concerns have also been raised about the substitution of similar)Tj T* 0.0914 Tw (but not therapeutically equivalent products and recall management. Most)Tj T* 0.0229 Tw [(serious of all, however)59.6(, is the increased potential for exploitation by counter-)]TJ T* 0.0055 Tc 0.1237 Tw (feiters, narcotics traffickers, organized criminals, and terrorists, leading to )Tj T* 0.0206 Tc 0.131 Tw (an increase in altered and counterfeit treatments entering the U.S. and)Tj T* -0.0002 Tc 0.0927 Tw [(increased risk for bioterrorism. The FDA, the W)89.6(orld Health Organization,)]TJ T* 0.0991 Tw (and pharmaceutical companies report that counterfeit cases are on the rise.)Tj T* 0.0206 Tc 0.1369 Tw (Other studies have documented links between counterfeit products and )Tj T* -0.0002 Tc 0.0541 Tw [(terrorist organizations, which engage in such activity to finance their opera-)]TJ T* -0.0038 Tc 0.0114 Tw [(tio)-3.8(ns \(5\).)]TJ 1.6364 -1.0909 TD -0.0157 Tc -0.0158 Tw (In 2003, the FDA and the U.S. Customs and Border Protection conducted a)Tj -1.6364 -1.0909 TD 0.0102 Tw (series of spot examinations of mail shipments of foreign drugs entering the U.S.)Tj T* -0.0255 Tc -0.0161 Tw [(Of the 1,153 imported drug products examined, the overwhelming majority of the)]TJ T* -0.0157 Tc 0.026 Tw (drugs \(88%\) were found to be in violation of U.S. federal pharmaceutical safety)Tj T* -0.0168 Tc -0.0248 Tw (or efficacy standards. These drugs came from many countries, including Canada,)Tj T* -0.017 Tc -0.0246 Tw (India, Thailand, and the Philippines. The potentially hazardous medicines found)Tj T* -0.0157 Tc 0.0187 Tw (included drugs different from those approved by the FDA, inadequately labeled)Tj /F5 1 Tf 12 0 0 12 302.5695 44.1436 Tm 0 Tc 0 Tw (9)Tj ET Q endstream endobj 51 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F7 24 0 R /F8 31 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 53 0 obj << /Length 5314 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 69.9869 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj 11 0 0 11 127 710.6533 Tm -0.0157 Tc 0.0112 Tw [(or packaged drugs, drugs withdrawn from the market, animal drugs that are not)]TJ 0 -1.0909 TD -0.0135 Tc 0.1271 Tw (approved for human use, drugs with dangerous interactions, drugs that carry)Tj T* 0.1273 Tw (risks requiring initial screening and/or periodic patient monitoring, and con-)Tj T* -0.0157 Tc 0.0129 Tw (trolled substances \(17\).)Tj 1.6364 -1.0909 TD 0.0113 Tw (On 20 May 2004, the Senate HELP Committee held a hearing where FDA)Tj -1.6364 -1.0909 TD -0.022 Tc -0.0196 Tw [(Associate Commissioners Hubbard and T)159.8(aylor warned of counterfeit medications)]TJ T* -0.0157 Tc 0.0568 Tw (from India, Indonesia, and Pakistan, as well as prescription drugs that have the)Tj T* -0.0164 Tc -0.0252 Tw (same chemical analysis as others but do not properly dissolve in the bloodstream. )Tj 1.6364 -1.0909 TD -0.0157 Tc -0.0173 Tw [(Finally)79.7(, the Government Accountability Office \(GAO\) reported in July 2004)]TJ -1.6364 -1.0909 TD -0.0094 Tw (that the FDA and U.S. Customs and Border Protection officials were concerned)Tj T* 0.0355 Tw (that the volume of imported, adulterated, misbranded, or unapproved prescrip-)Tj T* 0.1285 Tw (tion drugs is large and increasing. The GAO concluded that federal agencies )Tj T* -0.0194 Tc -0.0222 Tw (cannot assure American consumers that prescription drugs purchased from inter-)Tj T* -0.0123 Tc 0.126 Tw [(national distributors are safe, effective, or high-quality)79.7(. Another recent GAO)]TJ T* -0.0157 Tc 0.0129 Tw (report on drugs purchased from the Internet echoed these concerns.)Tj 1.6364 -1.0909 TD -0.0025 Tc 0.1266 Tw (The Secretaries of HHS for the Clinton and Bush administrations, the)Tj -1.6364 -1.0909 TD -0.0119 Tc -0.0193 Tw [(FDA, 11 former FDA Commissioners, the U.S. Customs Service, and the Drug)]TJ T* -0.0053 Tc 0.0129 Tw (Enforcement Administration have all voiced concerns over drug importation. )Tj /F8 1 Tf 0 -2.1818 TD 0 Tc 0 Tw (W)Tj 0.9089 0 TD -0.0001 Tc 0.0139 Tw (eaknesses in the Current System)Tj /F3 1 Tf -0.9089 -2.1818 TD -0.0053 Tc 0.0274 Tw (Those concerned with safety often point to weaknesses in the current system,)Tj 0 -1.0909 TD 0.049 Tw (which must be corrected before drug importation can be made legal. Lack of)Tj T* -0.0192 Tw (resources is a significant contributor to security lapses. The FDA currently has)Tj T* -0.0101 Tc -0.0211 Tw (only about 100 investigators nationwide to handle the approximately 10 million)Tj T* -0.0053 Tc 0.0961 Tw [(parcels coming into the U.S. annually)79.8(. At the U.S. Post Office Airport Mail)]TJ T* 0.0044 Tc 0.1196 Tw (Facility at JFK Airport, for example, only 1%2% of the 40,000 packages)Tj T* -0.0053 Tc 0.0859 Tw (received daily are inspected As a result, nonFDA-approved medications are)Tj T* 0.0213 Tw (entering the U.S. at a rapid pace. Random inspections conducted by the FDA)Tj T* 0.0029 Tc 0.1211 Tw (at several mail facilities revealed that 86%88% of the packages examined )Tj T* -0.0053 Tc 0.0129 Tw (contained nonFDA-approved drugs \(5\). )Tj 1.6364 -1.0909 TD -0.0099 Tc -0.0213 Tw (The current system also lacks a uniform mechanism to track medicine from)Tj -1.6364 -1.0909 TD -0.0053 Tc 0.1154 Tw (the point of manufacture to the point of sale, such as a chain of custody or)Tj T* 0.0152 Tw (pedigree, as well as uniform interstate standards to regulate wholesalers and)Tj T* -0.0012 Tc 0.1252 Tw (distributors. Furthermore, Internet pharmacies are not currently regulated,)Tj T* -0.0019 Tc 0.1259 Tw (making it difficult to ensure product quality and origin or to ensure that a )Tj T* -0.0053 Tc 0.0129 Tw (prescription is required or a physician is employed \(5\).)Tj 1.6364 -1.0909 TD -0.0027 Tw (The FDA has been particularly vulnerable to criticism following its failure)Tj -1.6364 -1.0909 TD 0.0056 Tc 0.1185 Tw (to inspect often enough the long-troubled British vaccine plant owned by)Tj T* -0.0053 Tc 0.0393 Tw [(Chiron, which the U.S. had counted on for half of its flu vaccine supply)79.9(. The)]TJ T* 0.0795 Tw [(plant)109.8(s entire vaccine supply was impounded last year after British regulators )]TJ T* 0.0129 Tw [(discovered serious problems, which were later confirmed by the FDA. )]TJ 1.6364 -1.0909 TD 0.0838 Tw [(The President)109.8(s fiscal year 2006 budget proposal would reduce funds for)]TJ -1.6364 -1.0909 TD 0.0131 Tw [(almost all FDA inspection programs, such as those that review overseas plants)]TJ T* 0.0854 Tw (that make prescription drugs bound for the U.S. If Congress approves these)Tj T* -0.002 Tc 0.126 Tw (provisions, the number of foreign drug plant inspections would drop 5.8%)Tj T* -0.0122 Tc -0.019 Tw (compared with estimated 2005 inspections. The only increases are an expansion)Tj T* -0.0053 Tc -0.0233 Tw (of a network of labs to analyze food for bioterror agents and increasing staffing)Tj T* 0.0867 Tw (in the office that monitors the safety of prescription drugs once they hit the)Tj T* 0.0129 Tw (market \(18\).)Tj /F5 1 Tf 12 0 0 12 299.7744 44.1436 Tm -0.0004 Tc 0 Tw (10)Tj ET Q endstream endobj 54 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F8 31 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 56 0 obj << /Length 4807 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 171.6172 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj /F8 1 Tf 11 0 0 11 127 711.1045 Tm -0.0001 Tc 0.0138 Tw [(High Cost of Ensuring Saf)9.7(ety and Uncer)-19.9(tainty of Sa)14.8(vings f)19.7(o)0.1(r)]TJ 0 -1.0909 TD 0 Tw [(Consumer)14.8(s)]TJ /F3 1 Tf 0 -2.1818 TD -0.0157 Tc 0.0578 Tw (A 2004 report by HHS found that assuring the safety of imported medications)Tj 0 -1.0909 TD 0.0231 Tw (would be so costlyhundreds of millions of dollarsthat consumers would see)Tj T* 0.0932 Tw (a price break of only about 1%. A 2004 analysis by the Congressional Budget)Tj T* -0.0069 Tc 0.1205 Tw (Office \(CBO\) similarly concluded that the savings from such a program are)Tj T* -0.0157 Tc 0.0041 Tw (expected to be small, especially in a Canada-only approach \(19\). Critics also fear)Tj T* 0.0221 Tw (that middlemen, such as wholesalers and Internet pharmacies, will reap most or)Tj T* 0.0049 Tw [(all of the savings from importing lower)34.8(-priced pharmaceuticals, rather than pass)]TJ T* 0.0129 Tw (the savings on to consumers.)Tj /F8 1 Tf 0 -2.1818 TD -0.0001 Tc 0.0138 Tw [(Impact on Resear)19.7(c)9.8(h)0.1( and De)14.8(velopment)]TJ /F3 1 Tf T* -0.0053 Tc -0.02 Tw (The U.S. continues to lead the world in biotechnology innovation because our)Tj 0 -1.0909 TD -0.0091 Tc -0.0221 Tw (national policies foster innovation. Unlike nations that impose price controls to)Tj T* -0.0142 Tc -0.017 Tw [(ensure prescription drug affordability)79.7(, pharmaceutical companies in the U.S. are)]TJ T* -0.0026 Tc 0.1266 Tw (free to sell at whatever price they choose. According to manufacturers, the)Tj T* -0.0157 Tc 0.0323 Tw (high price of drugs in the U.S. is largely a result of the pharmaceutical industry)Tj T* 0.0604 Tw (being a high-risk business that requires substantial investments in research and)Tj T* -0.0249 Tw [(development. Last year)59.7(, member companies of the Pharmaceutical Research and)]TJ T* -0.0214 Tc -0.0202 Tw (Manufacturers of America \(PhRMA\) spent more than $33 billion on research and)Tj T* -0.0157 Tc -0.0228 Tw (development. In contrast, all pharmaceutical companies, including those that are)Tj T* 0.082 Tw (not members of PhRMA, spent $21 billion on total promotion and marketing)Tj T* 0.0129 Tw (combined \(20\). )Tj 1.6364 -1.0909 TD -0.0114 Tc 0.125 Tw (Pharmaceutical companies argue that if importation were legalized, their)Tj -1.6364 -1.0909 TD -0.0153 Tc 0.129 Tw (incentive to invest in research and development would be reduced. The final)Tj T* -0.0157 Tc -0.0095 Tw [(report of the HHS T)159.8(ask Force concluded that legalizing imports would cut drug)]TJ T* -0.0187 Tc -0.0229 Tw (companies profits, which pay for research and development, resulting in three or)Tj T* -0.0164 Tc -0.0252 Tw (four fewer new drugs being approved each year \(3\). Another study estimated that)Tj T* -0.0144 Tc 0.1281 Tw [(if importation was approved, national research and development spending by)]TJ T* -0.0157 Tc 0.0895 Tw (pharmaceutical and biotechnology firms would plummet by $14.8 billion over )Tj T* 0.0776 Tw (the next 12 years and 262 life-saving drugs would be abandoned for economic )Tj T* -0.0087 Tc 0.1224 Tw (reasons \(21\). Importation could also erode incentives for providing)Tj 28.9421 0 TD 0.0016 Tc 0 Tw (low-cost)Tj -28.9421 -1.0909 TD -0.0053 Tc (generics. )Tj /F8 1 Tf 0 -2.1818 TD -0.0001 Tc 0.0138 Tw [(Disruptions in the Canadian Suppl)14.8(y)]TJ /F3 1 Tf T* -0.0053 Tc 0.0421 Tw (Still others warn of the adverse effect importation may have on the Canadian)Tj 0 -1.0909 TD 0.0347 Tw [(supply)79.7(. Canada, which fills about 300 million prescriptions annually)79.8(, lacks the)]TJ T* 0.1151 Tw (infrastructure and supply to provide for Americans, who fill 3.1 billion pre-)Tj T* -0.0118 Tw [(scriptions annually)79.8(, in addition to its own residents \(5\). Since Canada)109.8(s popula-)]TJ T* -0.0129 Tc -0.0183 Tw (tion is just a fraction of the size of the U.S., even a small portion of U.S. patients)Tj T* -0.0053 Tc 0.0178 Tw (ordering medications from across the border could overwhelm current supply)Tj T* 0.0925 Tw (and distribution systems. The end result would be higher prices and limited)Tj T* 0.0821 Tw (supplies for Canadian patients. In the event that Canada faces a prescription)Tj T* -0.0096 Tc -0.0216 Tw (drug shortage, the nation could declare an emergency and remove patent rights)Tj T* -0.0053 Tc -0.0123 Tw (for medications. In a worst-case scenario, the Canadian government could ban)Tj T* 0.0129 Tw [(all prescription drug exports to the U.S. )]TJ /F5 1 Tf 12 0 0 12 299.4567 44.1436 Tm -0.0004 Tc 0 Tw (11)Tj ET Q endstream endobj 57 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F8 31 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 59 0 obj << /Length 4894 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 69.9869 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj /F8 1 Tf 11 0 0 11 127 711.1045 Tm -0.0001 Tc 0.0138 Tw (Liability Concerns)Tj /F3 1 Tf 0 -2.1818 TD -0.0053 Tc 0.1055 Tw [(Importation also raises concerns about liability in the event that a patient is)]TJ 0 -1.0909 TD 0.0075 Tw (harmed by an imported medicine. American pharmaceutical companies, phar-)Tj T* -0.0086 Tc -0.0226 Tw (macies, pharmacists, hospitals, and physicians can all be sued and held liable for)Tj T* -0.0053 Tc 0.1196 Tw (prescribing and dispensing imported medications that injure patients. Many)Tj T* 0.0925 Tw (complicated issues related to liability have yet to be resolved, including who)Tj T* -0.0123 Tw [(would be at fault \(i.e., importer)59.7(, prescribing physician, dispensing pharmacists,)]TJ T* -0.0107 Tc -0.0205 Tw (or manufacturer\), jurisdiction \(e.g., suits might require going to foreign courts\),)Tj T* -0.0053 Tc 0.0882 Tw (and the role of the patient \(e.g., determining patient fault when he or she is)Tj T* 0.0129 Tw (aware of the source of the product\).)Tj /F8 1 Tf 0 -2.1818 TD -0.0002 Tc 0.0139 Tw [(Alternative )79.6(W)39.7(a)19.7(ys f)19.6(or Consumer)14.7(s to Access Lo)14.7(wer)19.6(-Cost Drugs)]TJ /F3 1 Tf T* -0.0151 Tc -0.0161 Tw (Significant progress has been made over the last few years in both the public and)Tj 0 -1.0909 TD -0.0077 Tc -0.0235 Tw (private sector to improve patients access to affordable medications. The MMA)Tj T* -0.0075 Tc -0.0237 Tw [(of 2003 includes a comprehensive outpatient prescription drug benefit that will)]TJ T* -0.0053 Tc 0.0842 Tw [(be available to all Medicare beneficiaries beginning on 1 January 2006. This)]TJ T* -0.0082 Tc -0.023 Tw (benefit will provide savings on medications for Medicare beneficiaries, with the)Tj T* -0.0053 Tc 0.0208 Tw (most assistance being provided to low-income individuals and those with very)Tj T* -0.0138 Tc -0.0174 Tw (high drug expenditures. Forty million Medicare beneficiaries, including approx-)Tj T* -0.0053 Tc -0.0203 Tw [(imately 12 million without any coverage today)79.9(, will be able to access affordable)]TJ T* 0.0154 Tc 0.2392 Tw (and safe medications with protection against high out-of-pocket costs.)Tj T* -0.0053 Tc -0.0136 Tw (Approximately 11 million low-income elderly and disabled individuals will pay)Tj T* 0.0129 Tw (only minimal co-payments for this coverage. )Tj 1.6364 -1.0909 TD -0.0157 Tc 0.1252 Tw (In addition to the new Medicare benefit, the pharmaceutical industry has)Tj -1.6364 -1.0909 TD -0.0201 Tc -0.0215 Tw (taken steps to improve access to medicines for the uninsured. Eli Lilly created the)Tj T* -0.0234 Tc -0.0182 Tw [(Lilly Cares program, which offers free medication, through physicians, to patients)]TJ T* -0.0157 Tc 0.0538 Tw (who are otherwise unable to obtain their products. Eli Lilly also developed the)Tj T* -0.0209 Tc 0.0226 Tw [(LillyAnswers program to help address concerns about growing medical expense)-5.1(s)]TJ T* -0.0157 Tc -0.0074 Tw (for Medicare recipients without prescription drug coverage. For eligible seniors,)Tj T* 0.0295 Tw (LillyAnswers provides a 30-day supply of any Lilly retail drug for a flat $12 fee.)Tj T* -0.0176 Tc -0.024 Tw [(Pfizer)109.7(s Helpful Answers Initiative includes the Pfizer Pfriends program, through)]TJ T* -0.0109 Tc 0.1246 Tw (which low-income, uninsured families can buy medicines at prices similar to)Tj T* -0.0066 Tc 0.1203 Tw (those paid by large purchasers, as well as the Connection to Care program,)Tj T* -0.0157 Tc 0.0659 Tw (through which families making $31,000 or less per year can receive free Pfizer)Tj T* -0.021 Tw (medicines from their physicians offices. Novartis and nine other pharmaceutical)Tj T* -0.0188 Tc -0.0228 Tw [(companies recently launched the T)179.8(ogether Rx Access card, a free program, which)]TJ T* 0.005 Tc 0.1839 Tw (provides low-income uninsured individuals with savings of approximately)Tj T* -0.0157 Tc 0.0003 Tw [(25%40% on a wide range of prescription products. Finally)79.7(, the Partnership for)]TJ T* 0.0092 Tw [(Prescription Assistance \(PP)74.8(A\) is another collaborative effort among pharmaceu-)]TJ T* -0.0062 Tw (tical companies, health care providers, patient advocacy organizations, and com-)Tj T* -0.0157 Tw (munity groups to help qualifying patients who lack prescription coverage get the)Tj T* -0.0075 Tw [(medicines they need. The PP)74.8(A \(www)79.7(.pparx.org\) offers a single point of access to)]TJ T* 0.0913 Tw (more than 275 public and private patient assistance programs, including more)Tj T* 0.0129 Tw (than 150 programs offered by pharmaceutical companies. )Tj /F5 1 Tf 12 0 0 12 299.7744 44.1436 Tm -0.0004 Tc 0 Tw (12)Tj ET Q endstream endobj 60 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F8 31 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 62 0 obj << /Length 5130 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 171.6172 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj /F7 1 Tf 14 0 0 14 91 708.9512 Tm -0.0001 Tc -0.0658 Tw [(Where W)35(e)0.1( )-79.6(Stand)]TJ /F3 1 Tf 11 0 0 11 127 690.9512 Tm -0.0053 Tc 0.0837 Tw [(In January 2005, the College)109.8(s Board of Regents \(BOR\) voted to modify the)]TJ 0 -1.0909 TD 0.0634 Tw [(College)109.8(s policy on prescription drug importation. An ACP policy previously)]TJ T* 0.0893 Tw (oppose[d] reimportation until safety concerns raised by HHS and the FDA)Tj T* 0.0963 Tw (were resolved. The new policy states that ACP supports legislative and/or)Tj T* 0.0392 Tw (regulatory measures to develop a process to ascertain and certify the safety of)Tj T* -0.015 Tc -0.0162 Tw (reimported prescription drugs. The position was amended to allow the College)Tj T* -0.0053 Tc 0.0351 Tw (to be more responsive to patients suffering from the high cost of prescription)Tj T* 0.0031 Tc 0.1209 Tw [(drugs without criticizing the pharmaceutical industry)109.8(s)0( pricing practices or )]TJ T* -0.0053 Tc 0.0129 Tw (dictating how the industry should be paid. )Tj 1.6364 -1.0909 TD 0.1235 Tw (Although this modified policy allows the College to respond more pro-)Tj -1.6364 -1.0909 TD 0.0084 Tc 0.1156 Tw [(actively)79.7(, its lack of specificity makes it an inadequate tool to evaluate and)]TJ T* -0.0138 Tc -0.0174 Tw (respond to quickly evolving importation proposals and actions at the federal and)Tj T* -0.0157 Tc 0.0282 Tw [(state level. The following recommendations, based on the arguments presente)-10.3(d)]TJ T* -0.0053 Tc 0.0012 Tw [(in this paper)59.7(, will better guide the College in evaluating proposals on the issue)]TJ T* 0.0129 Tw (of prescription drug importation: )Tj /F9 1 Tf 1.6364 -2.1818 TD -0.0057 Tc 0.1252 Tw (Recommendation 1: )Tj /F3 1 Tf 9.6314 0 TD -0.0053 Tc 0.1166 Tw (Action is needed, including consideration of drug)Tj -11.2677 -1.0909 TD -0.0061 Tc -0.0251 Tw (importation, to reduce the high cost of prescription drugs in the United States.)Tj T* -0.0178 Tc -0.0238 Tw [(However)59.7(, assuring high quality and patient safety must remain the top priorit)-10.4(y)-10.4( )-10.4(o)-10.4(f)]TJ T* -0.0053 Tc 0.0129 Tw (any cost control program.)Tj /F9 1 Tf 1.6364 -2.1818 TD 0.0001 Tc 0.1331 Tw (Recommendation 2: )Tj /F3 1 Tf 9.7507 0 TD 0 Tc 0.124 Tw (Before legalizing the importation of prescription)Tj -11.387 -1.0909 TD -0.0053 Tc 0.0129 Tw (drugs, Congress should: )Tj 2.1818 -2.1818 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc 0.1179 Tw (Permit state pilot programs to test the safe implementation of pre-)Tj 0 -1.0909 TD -0.0021 Tc -0.0239 Tw [(scription drug importation programs. T)139.7(rials could initially be aimed at)]TJ T* -0.0002 Tc 0.079 Tw (individuals without drug coverage. The results of such pilots should)Tj T* 0.013 Tw [(serve as a model for the federal government and individual states. )]TJ -1.0909 -1.0909 TD 0.5719 Tc 0 Tw (C)Tj 1.8515 0 TD 0.0018 Tc 0.1274 Tw (reate an independent FDA oversight board to handle drug safety)Tj -0.7606 -1.0909 TD -0.0049 Tc -0.0211 Tw (issues, including those related to prescription drug importation, and to)Tj T* -0.0002 Tc 0.0269 Tw [(communicate more effectively with patients and physicians about the)]TJ T* -0.0001 Tc 0.0129 Tw [(risks and benefits of such medications. )]TJ -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc -0.0106 Tw (Study and report on the effectiveness of promising new and emerging)Tj 0 -1.0909 TD -0.007 Tc -0.019 Tw (anti-counterfeiting technologies, such as radio frequency chips to track)Tj T* -0.0052 Tc -0.0208 Tw (drug shipments. Nevertheless, it should be recognized that widespread)Tj T* -0.0002 Tc 0.0464 Tw (adoption of authentication technologies is a daunting task that could)Tj T* -0.0086 Tc -0.0174 Tw [(raise the cost of imported drugs, thereby reducing any expected savings)]TJ T* -0.0002 Tc 0.0129 Tw (from importation.)Tj -1.0909 -1.0909 TD 0.5719 Tc 0 Tw (U)Tj 1.934 0 TD 0.0102 Tc 0.119 Tw [(rge the expansion of accreditation programs. In particular)59.6(, ACP)]TJ -0.8431 -1.0909 TD -0.0002 Tc 0.0525 Tw [(urges the NABP to consider applying its Internet pharmacy accredi-)]TJ T* 0.0996 Tw [(tation program on an international level to help consumers identify)]TJ T* 0.013 Tw (legitimate Internet pharmacies.)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD 0.0122 Tc 0.117 Tw [(Enhance resources of the FDA to inspect facilities manufacturing )]TJ 0 -1.0909 TD -0.0002 Tc -0.0258 Tw (prescription drugs for export to the U.S. and enhance resources of the)Tj T* -0.0133 Tw (FDA, the U.S. Customs Service, law enforcement agencies, and other)Tj T* -0.0009 Tw (federal agencies involved in assuring that products that are illegal, are)Tj T* 0.0518 Tw (counterfeit, or do not meet U.S. safety and quality standards are not)Tj T* 0.013 Tw (allowed into the U.S. )Tj /F5 1 Tf 12 0 0 12 299.4567 44.1436 Tm -0.0004 Tc 0 Tw (13)Tj ET Q endstream endobj 63 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F7 24 0 R /F9 64 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 66 0 obj << /Length 4848 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 69.9869 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj /F9 1 Tf 11 0 0 11 145 710.6533 Tm -0.0057 Tc -0.0067 Tw (Recommendation 3)Tj /F3 1 Tf 8.8297 0 TD -0.0053 Tc -0.0063 Tw (: ACP believes that any drug importation system that)Tj -10.4661 -1.0909 TD 0.0129 Tw (Congress approves should:)Tj 2.1818 -2.1818 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc 0.1288 Tw (Be a closed system, in which participating pharmacies and Internet)Tj 0 -1.0909 TD 0.013 Tw (sites must meet FDA standards;)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc 0.013 Tw (Have a tightly controlled and documented supply chain;)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD 0.0121 Tc 0.1171 Tw (Not include controlled substances, biologics, or products that are)Tj 0 -1.0909 TD 0.0186 Tc 0.1106 Tw (infused/injected or products that are photoreactive or have strict )Tj T* -0.0002 Tc 0.0129 Tw (temperature requirements; )Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0157 Tc 0.0683 Tw (Be limited to countries that meet U.S. standards to assure high quality)Tj 0 -1.0909 TD -0.0002 Tc 0.013 Tw (and patient safety of imported drugs;)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0001 Tc 0.1145 Tw (Include adequate resources for inspections of facilities and enforce-)Tj 0 -1.0909 TD -0.0002 Tc 0.013 Tw (ment of U.S. requirements; and )Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0001 Tc 0.0866 Tw [(Require that only prescriptions written by a U.S.-licensed physician)]TJ 0 -1.0909 TD -0.0209 Tc 0.0024 Tw [(with an established professional relationship with the patient be accepte)-20.6(d)]TJ T* -0.0002 Tc 0.013 Tw (for importation. )Tj /F9 1 Tf -1.6364 -2.1818 TD -0.0036 Tc 0.1368 Tw (Recommendation 4: )Tj /F3 1 Tf 9.6927 0 TD -0.0034 Tc 0.1274 Tw (Prescription drug importation is not a long-term)Tj -11.3291 -1.0909 TD -0.0053 Tc 0.0567 Tw (solution to the high cost of prescription drugs, which is having a detrimental)Tj T* 0.0025 Tc 0.1215 Tw (effect on Americans access to life-saving therapies. ACP urges the federal )Tj T* -0.0055 Tc -0.0257 Tw (government to take immediate action to improve access to pharmaceuticals by:)Tj 2.1818 -2.1818 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD 0.0015 Tc 0.1277 Tw [(Assuring there are sufficient incentives for pharmaceutical research)]TJ 0 -1.0909 TD -0.0002 Tc 0.013 Tw (and development;)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0157 Tc 0.0129 Tw (Encouraging increased competition among brand-name manufacturers;)Tj -1.0909 -1.0909 TD 0.5719 Tc 0 Tw (S)Tj 1.6468 0 TD -0.0001 Tc 0.0129 Tw [(peeding the approval and encouraging the use of generic drugs;)]TJ -1.6468 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0157 Tc 0.0174 Tw (Negotiating volume discounts on prescription drug prices and pursuing)Tj 0 -1.0909 TD 0.006 Tc 0.1232 Tw (prescription drug bulk purchasing agreements under the Medicare)Tj T* -0.0002 Tc 0 Tw (program;)Tj -1.0909 -1.0909 TD 0 Tc ()Tj 1.0909 0 TD -0.0061 Tc -0.0199 Tw (Expanding the availability of public and private sector health insurance)Tj 0 -1.0909 TD -0.0002 Tc 0.013 Tw (that includes coverage for prescription drugs;)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD 0.0033 Tc 0.1259 Tw (Encouraging pharmaceutical manufacturers to expand their patient)Tj 0 -1.0909 TD -0.0002 Tc -0.0008 Tw (assistance and drug discount programs and increase patient education)Tj T* -0.0001 Tc 0.0129 Tw (for these programs;)Tj -1.0909 -1.0909 TD 0.5719 Tc 0 Tw (P)Tj 1.7148 0 TD -0.0061 Tc -0.0199 Tw (rotecting state pharmaceutical programs that may be impacted by the)Tj -0.6239 -1.0909 TD -0.0001 Tc 0.0128 Tw (new Medicare law;)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc 0.013 Tw [(Reviewing recent increases in the cost of pharmaceuticals;)]TJ -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD 0.0057 Tc 0.1235 Tw (Studying the effectiveness of prescription drug substitutes, such as)Tj 0 -1.0909 TD -0.0002 Tc 0.013 Tw [(lower)34.7(-cost, therapeutically equivalent medications;)]TJ -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0157 Tc 0.0129 Tw (Encouraging and helping to implement disease management programs;)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0001 Tc 0.0129 Tw (Encouraging the use of evidence-based medicine; and)Tj -1.0909 -1.0909 TD 0 Tc 0 Tw ()Tj 1.0909 0 TD -0.0002 Tc 0.013 Tw (Considering limits on direct-to-consumer drug advertising. )Tj -1.6364 -2.1818 TD -0.0053 Tc 0.0149 Tw [(ACP should work with its members to carry out those reforms of which it)]TJ -1.6364 -1.0909 TD -0.0054 Tc 0.013 Tw (is capable. )Tj /F5 1 Tf 12 0 0 12 299.7744 44.1436 Tm -0.0004 Tc 0 Tw (14)Tj ET Q endstream endobj 67 0 obj << /ProcSet [/PDF /Text ] /Font << /F3 15 0 R /F5 16 0 R /F9 64 0 R >> /ExtGState << /GS2 8 0 R /GS3 17 0 R >> >> endobj 69 0 obj << /Length 4879 >> stream 1 g /GS3 gs 0 792 m 0 792 l f q 0.2 i 0 792 612 -792 re 0 792 m W n 0 792.015 612 -792 re W n BT /F3 1 Tf 9 0 0 9 171.6172 748.1709 Tm 0 0 0 1 k /GS2 gs -0.0002 Tc 0.013 Tw (Prescription Drug Importation as a Policy Option to Lower the Cost of Medications in the U.S.)Tj /F7 1 Tf 14 0 0 14 91 708.9512 Tm -0.0001 Tc 0 Tw [(Glossar)-9.9(y)]TJ /F9 1 Tf 11 0 0 11 127 690.9512 Tm -0.0057 Tc (AMA: )Tj /F3 1 Tf 2.9495 0 TD -0.0053 Tc 0.0129 Tw (American Medical Association.)Tj /F9 1 Tf -2.9495 -2.1818 TD -0.0057 Tc 0 Tw (BOR: )Tj /F3 1 Tf 2.9419 0 TD -0.0053 Tc 0.0924 Tw [(Board of Regentsmanages the business and affairs of ACP)149.8(. 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