I 

109TH CONGRESS 

2D SESSION H. R. 4792 

To fix the Medicare Part D prescription drug program by requiring the 

Secretary of Health and Human Services to negotiate fair prices for 

prescription drugs on behalf of Medicare beneficiaries, to further reduce 

drug costs to consumers by allowing the importation of prescription 

drugs under the Federal Food, Drug, and Cosmetic Act, to provide 

seniors with adequate time to consider their options under Medicare 

part D by extending the 2006 Medicare prescription drug enrollment 

period through December 31, 2006, without penalty, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 16, 2006 

Mr. LARSEN of Washington (for himself and Mr. MCDERMOTT) introduced the 

following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means and Judiciary, for a period to be subsequently determined by the Speaker, in each 

case for consideration of such provisions as fall within the jurisdiction of 

the committee concerned 

A BILL 

To fix the Medicare Part D prescription drug program by 

requiring the Secretary of Health and Human Services 

to negotiate fair prices for prescription drugs on behalf 

of Medicare beneficiaries, to further reduce drug costs 

to consumers by allowing the importation of prescription 

drugs under the Federal Food, Drug, and Cosmetic Act, 

to provide seniors with adequate time to consider their 

options under Medicare part D by extending the 2006 

Medicare prescription drug enrollment period through 


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December 31, 2006, without penalty, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Fix Medicare Part D 

5 Act’’. 

6 TITLE I—NEGOTIATION OF FAIR 

7 DRUG PRICES 

8 SEC. 101. NEGOTIATING FAIR PRICES FOR MEDICARE PRE9 SCRIPTION DRUGS ON BEHALF OF MEDICARE 

10 BENEFICIARIES. 

11 Section 1860D–11 of the Social Security Act (42 

12 U.S.C. 1395–111) is amended by striking subsection (i) 

13 (relating to noninterference) and by inserting the fol14 lowing: 

15 ‘‘(i) REQUIREMENT TO NEGOTIATE PRICES WITH

16 MANUFACTURERS.—In order to ensure that beneficiaries 

17 enrolled under prescription drug plans and MA–PD plans 

18 pay the lowest possible price, the Secretary shall have and 

19 exercise authority similar to that of the Secretary of Vet20 erans Affairs, Secretary of Defense, and the heads of other 

21 Federal agencies and departments that purchase prescrip22 tion drugs in bulk to negotiate contracts with manufactur23 ers of covered part D drugs, consistent with the requireVerDate Aug 31 2005 03:00 Feb 23, 2006 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4792.IH H4792

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1 ments and in furtherance of the goals of providing quality 

2 care and containing costs under this part.’’. 

3 TITLE II—DRUG IMPORTATION 

4 IMPROVEMENTS 

5 SEC. 201. SHORT TITLE. 

6 This title may be cited as the ‘‘Pharmaceutical Mar7 ket Access Act of 2006’’. 

8 SEC. 202. FINDINGS. 

9 Congress finds as follows: 

10 (1) Americans unjustly pay up to 1000 percent 

11 more to fill their prescriptions than consumers in 

12 other countries. 

13 (2) The United States is the world’s largest 

14 market for pharmaceuticals yet consumers still pay 

15 the world’s highest prices. 

16 (3) An unaffordable drug is neither safe nor ef17 fective. Allowing and structuring the importation of 

18 prescription drugs ensures access to affordable 

19 drugs, thus providing a level of safety to American 

20 consumers they do not currently enjoy. 

21 (4) According to the Congressional Budget Of22 fice, American seniors alone will spend 

23 $1,800,000,000,000 on pharmaceuticals over the 

24 next 10 years. 


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1 (5) Allowing open pharmaceutical markets 

2 could save American consumers at least 

3 $635,000,000,000 of their own money. 

4 SEC. 203. PURPOSES. 

5 The purposes of this title are as follows: 

6 (1) To give all Americans immediate relief from 

7 the outrageously high cost of pharmaceuticals. 

8 (2) To reverse the perverse economics of the 

9 American pharmaceutical market. 

10 (3) To allow the importation of prescription 

11 drugs only if the drugs and facilities where such 

12 drugs are manufactured are approved by the Food 

13 and Drug Administration, and to exclude pharma14 ceutical narcotics. 

15 (4) To require that imported prescription drugs 

16 be packaged and shipped using counterfeit-resistant 

17 technologies. 

18 SEC. 204. AMENDMENTS TO SECTION 804 OF THE FEDERAL 

19 FOOD, DRUG, AND COSMETIC ACT. 

20 (a) DEFINITIONS.—Section 804(a) of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 384(a)) is 

22 amended to read as follows: 

23 ‘‘(a) DEFINITIONS.—In this section: 


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1 ‘‘(1) IMPORTER.—The term ‘importer’ means a 

2 pharmacy, group of pharmacies, pharmacist, or 

3 wholesaler. 

4 ‘‘(2) PERMITTED COUNTRY.—The term ‘per5 mitted country’ means a country, union, or economic 

6 area that is listed in subparagraph (A) of section 

7 802(b)(1) (as of December 31, 2003), except that 

8 the Secretary— 

9 ‘‘(A) may add a country, union, or eco10 nomic area to such list for purposes of this sec11 tion if the Secretary determines that the coun12 try, union, or economic area has a pharma13 ceutical infrastructure that is substantially 

14 equivalent or superior to the pharmaceutical in15 frastructure of the United States, taking into 

16 consideration pharmacist qualifications, phar17 macy storage procedures, the drug distribution 

18 system, the drug dispensing system, and market 

19 regulation; and 

20 ‘‘(B) may remove a country, union, or eco21 nomic area from such list for purposes of this 

22 section if the Secretary determines that the 

23 country, union, or economic area does not have 

24 such a pharmaceutical infrastructure. 


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1 ‘‘(3) PHARMACIST.—The term ‘pharmacist’ 

2 means a person licensed by the relevant govern3 mental authority to practice pharmacy, including the 

4 dispensing and selling of prescription drugs. 

5 ‘‘(4) PHARMACY.—The term ‘pharmacy’ means 

6 a person that is licensed by the relevant govern7 mental authority to engage in the business of selling 

8 prescription drugs that employs 1 or more phar9 macists. 

10 ‘‘(5) PRESCRIPTION DRUG.—The term ‘pre11 scription drug’ means a drug subject to section 

12 503(b), other than— 

13 ‘‘(A) a controlled substance (as defined in 

14 section 102 of the Controlled Substances Act 

15 (21 U.S.C. 802)); 

16 ‘‘(B) a biological product (as defined in 

17 section 351 of the Public Health Service Act 

18 (42 U.S.C. 262)); 

19 ‘‘(C) an infused drug (including a peri20 toneal dialysis solution); 

21 ‘‘(D) an intravenously injected drug; 

22 ‘‘(E) a drug that is inhaled during surgery; 

23 or 

24 ‘‘(F) a drug which is a parenteral drug, 

25 the importation of which pursuant to subsection 


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1 (b) is determined by the Secretary to pose a 

2 threat to the public health, in which case sec3 tion 801(d)(1) shall continue to apply. 

4 ‘‘(6) QUALIFYING DRUG.—The term ‘qualifying 

5 drug’ means a prescription drug that— 

6 ‘‘(A) is approved pursuant to an applica7 tion submitted under section 505(b)(1); and 

8 ‘‘(B) is not— 

9 ‘‘(i) a drug manufactured through 1 

10 or more biotechnology processes; 

11 ‘‘(ii) a drug that is required to be re12 frigerated; or 

13 ‘‘(iii) a photoreactive drug. 

14 ‘‘(7) QUALIFYING INTERNET PHARMACY.—The 

15 term ‘qualifying Internet pharmacy’ means a reg16 istered exporter that dispenses qualifying drugs to 

17 individuals over an Internet website. 

18 ‘‘(8) QUALIFYING LABORATORY.—The term 

19 ‘qualifying laboratory’ means a laboratory in the 

20 United States that has been approved by the Sec21 retary for the purposes of this section. 

22 ‘‘(9) REGISTERED EXPORTER.—The term ‘reg23 istered exporter’ means a person that is in the busi24 ness of exporting a drug to persons in the United 

25 States (or that seeks to be in such business), for 


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1 which a registration under this section has been ap2 proved and is in effect. 

3 ‘‘(10) WHOLESALER.— 

4 ‘‘(A) IN GENERAL.—The term ‘wholesaler’ 

5 means a person licensed as a wholesaler or dis6 tributor of prescription drugs in the United 

7 States under section 503(e)(2)(A). 

8 ‘‘(B) EXCLUSION.—The term ‘wholesaler’ 

9 does not include a person authorized to import 

10 drugs under section 801(d)(1).’’. 

11 (b) REGULATIONS.—Section 804(b) of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 384(b)) is 

13 amended to read as follows: 

14 ‘‘(b) REGULATIONS.—Not later than 180 days after 

15 the date of enactment of the Pharmaceutical Market Ac16 cess Act of 2006, the Secretary, after consultation with 

17 the United States Trade Representative and the Commis18 sioner of Customs, shall promulgate regulations permit19 ting pharmacists, pharmacies, and wholesalers to import 

20 qualifying drugs from permitted countries into the United 

21 States.’’. 

22 (c) LIMITATION.—Section 804(c) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 384(c)) is 

24 amended by striking ‘‘prescription drug’’ each place it ap25 pears and inserting ‘‘qualifying drug’’. 


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1 (d) INFORMATION AND RECORDS.—Section 

2 804(d)(1) of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 384(d)(1)) is amended— 

4 (1) by striking subparagraph (G) and redesig5 nating subparagraphs (H) through (N) as subpara6 graphs (G) through (M), respectively; 

7 (2) in subparagraph (H) (as so redesignated), 

8 by striking ‘‘telephone number, and professional li9 cense number (if any)’’ and inserting ‘‘and telephone 

10 number’’; and 

11 (3) in subparagraph (L) (as so redesignated), 

12 by striking ‘‘(J) and (L)’’ and inserting ‘‘(I) and 

13 (K)’’. 

14 (e) TESTING.—Section 804(e) of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 384(e)) is amended 

16 to read as follows: 

17 ‘‘(e) TESTING.—The regulations under subsection (b) 

18 shall require that the testing described under subpara19 graphs (I) and (K) of subsection (d)(1) be conducted by 

20 the importer of the qualifying drug, unless the qualifying 

21 drug is subject to the requirements under section 505C 

22 for counterfeit-resistant technologies.’’. 

23 (f) REGISTRATION OF EXPORTERS; INSPECTIONS.— 

24 Section 804(f) of the Federal Food, Drug, and Cosmetic 

25 Act (21 U.S.C. 384(f)) is amended to read as follows: 


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1 ‘‘(f) REGISTRATION OF EXPORTERS; INSPECTIONS.— 

2 ‘‘(1) IN GENERAL.—Any person that seeks to 

3 be a registered exporter (referred to in this sub4 section as the ‘registrant’) shall submit to the Sec5 retary a registration that includes the following: 

6 ‘‘(A) The name of the registrant and iden7 tification of all places of business of the reg8 istrant that relate to qualifying drugs, including 

9 each warehouse or other facility owned or con10 trolled by, or operated for, the registrant; 

11 ‘‘(B) An agreement by the registrant to— 

12 ‘‘(i) make its places of business that 

13 relate to qualifying drugs (including ware14 houses and other facilities owned or con15 trolled by, or operated for, the exporter) 

16 and records available to the Secretary for 

17 on-site inspections, without prior notice, 

18 for the purpose of determining whether the 

19 registrant is in compliance with this Act’s 

20 requirements; 

21 ‘‘(ii) export only qualifying drugs; 

22 ‘‘(iii) export only to persons author23 ized to import the drugs; 

24 ‘‘(iv) notify the Secretary of a recall 

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1 uted in a permitted country to or from 

2 which the registrant has exported or im3 ported, or intends to export or import, to 

4 the United States; 

5 ‘‘(v) monitor compliance with registra6 tion conditions and report any noncompli7 ance promptly; 

8 ‘‘(vi) submit a compliance plan show9 ing how the registrant will correct viola10 tions, if any; and 

11 ‘‘(vii) promptly notify the Secretary of 

12 changes in the registration information of 

13 the registrant. 

14 ‘‘(2) NOTICE OF APPROVAL OR DISAPPROVAL.— 

15 ‘‘(A) IN GENERAL.—Not later than 90 

16 days after receiving a completed registration 

17 from a registrant, the Secretary shall— 

18 ‘‘(i) notify such registrant of receipt 

19 of the registration; 

20 ‘‘(ii) assign such registrant a registra21 tion number; and 

22 ‘‘(iii) approve or disapprove the appli23 cation. 

24 ‘‘(B) DISAPPROVAL OF APPLICATION.— 

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1 ‘‘(i) IN GENERAL.—The Secretary 

2 shall disapprove a registration, and notify 

3 the registrant of such disapproval, if the 

4 Secretary has reason to believe that such 

5 registrant is not in compliance with a reg6 istration condition. 

7 ‘‘(ii) SUBSEQUENT APPROVAL.—The 

8 Secretary may subsequently approve a reg9 istration that was denied under clause (i) 

10 if the Secretary finds that the registrant is 

11 in compliance with all registration condi12 tions. 

13 ‘‘(3) LIST.—The Secretary shall— 

14 ‘‘(A) maintain an up-to-date list of reg15 istered exporters (including qualifying Internet 

16 pharmacies that sell qualifying drugs to individ17 uals); 

18 ‘‘(B) make such list available to the public 

19 on the Internet site of the Food and Drug Ad20 ministration and via a toll-free telephone num21 ber; and 

22 ‘‘(C) update such list promptly after the 

23 approval of a registration under this subsection. 

24 ‘‘(4) EDUCATION OF CONSUMERS.—The Sec25 retary shall carry out activities, by use of the InterVerDate Aug 31 2005 03:00 Feb 23, 2006 Jkt 049200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H4792.IH H4792

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1 net website and toll-free telephone number under 

2 paragraph (3), that educate consumers with regard 

3 to the availability of qualifying drugs for import for 

4 personal use under this section, including informa5 tion on how to verify whether an exporter is reg6 istered. 

7 ‘‘(5) INSPECTION OF IMPORTERS AND REG8 ISTERED EXPORTERS.—The Secretary shall inspect 

9 the warehouses, other facilities, and records of im10 porters and registered exporters as often as the Sec11 retary determines necessary to ensure that such im12 porters and registered exporters are in compliance 

13 with this section.’’. 

14 (g) SUSPENSION OF IMPORTATION.—Section 804(g) 

15 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

16 384(g)) is amended by— 

17 (1) striking ‘‘and the Secretary determines that 

18 the public is adequately protected from counterfeit 

19 and violative prescription drugs being imported 

20 under subsection (b)’’; and 

21 (2) by adding after the period at the end the 

22 following: ‘‘The Secretary shall reinstate the impor23 tation by a specific importer upon a determination 

24 by the Secretary that the violation has been cor25 rected and that the importer has demonstrated that 


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1 further violations will not occur. This subsection 

2 shall not apply to a prescription drug imported by 

3 an individual, or to a prescription drug shipped to 

4 an individual by a qualifying Internet pharmacy.’’. 

5 (h) WAIVER AUTHORITY FOR INDIVIDUALS.—Section 

6 804(j) of the Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 384(j)) is amended to read as follows: 

8 ‘‘(j) IMPORTATION BY INDIVIDUALS.— 

9 ‘‘(1) IN GENERAL.—Not later than 180 days 

10 after the enactment of the Pharmaceutical Market 

11 Access Act of 2006, the Secretary shall by regula12 tion permit an individual to import a drug from a 

13 permitted country to the United States if the drug 

14 is— 

15 ‘‘(A) a qualifying drug; 

16 ‘‘(B) imported from a licensed pharmacy 

17 or qualifying Internet pharmacy; 

18 ‘‘(C) for personal use by an individual, or 

19 family member of the individual, not for resale; 

20 ‘‘(D) in a quantity that does not exceed a 

21 90-day supply during any 90-day period; and 

22 ‘‘(E) accompanied by a copy of a prescrip23 tion for the drug, which— 

24 ‘‘(i) is valid under applicable Federal 

25 and State laws; and 


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1 ‘‘(ii) was issued by a practitioner who 

2 is authorized to administer prescription 

3 drugs. 

4 ‘‘(2) DRUGS DISPENSED OUTSIDE THE UNITED

5 STATES.—An individual may import a drug from a 

6 country that is not a permitted country if— 

7 ‘‘(A) the drug was dispensed to the indi8 vidual while the individual was in such country, 

9 and the drug was dispensed in accordance with 

10 the laws and regulations of such country; 

11 ‘‘(B) the individual is entering the United 

12 States and the drug accompanies the individual 

13 at the time of entry; 

14 ‘‘(C) the drug is approved for commercial 

15 distribution in the country in which the drug 

16 was obtained; 

17 ‘‘(D) the drug does not appear to be adul18 terated; and 

19 ‘‘(E) the quantity of the drug does not ex20 ceed a 14-day supply.’’. 

21 (i) REPEAL OF CERTAIN PROVISIONS.—Section 804 

22 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

23 384) is amended by striking subsections (l) and (m). 


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1 SEC. 205. REGISTRATION FEES. 

2 Subchapter C of chapter VII of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 397f et seq.) is 

4 amended by adding at the end the following: 

5 ‘‘PART 5—FEES RELATING TO PRESCRIPTION 

6 DRUG IMPORTATION 

7 ‘‘SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IM8 PORTATION. 

9 ‘‘(a) REGISTRATION FEE.—The Secretary shall es10 tablish a registration fee program under which a reg11 istered exporter under section 804 shall be required to pay 

12 an annual fee to the Secretary in accordance with this sub13 section. 

14 ‘‘(b) COLLECTION.— 

15 ‘‘(1) COLLECTION ON INITIAL REGISTRATION.— 

16 A fee under this section shall be payable for the fis17 cal year in which the registered exporter first sub18 mits a registration under section 804 (or reregisters 

19 under that section if that person has withdrawn its 

20 registration and subsequently reregisters) in a 

21 amount of $10,000, due on the date the exporter 

22 first submits a registration to the Secretary under 

23 section 804. 

24 ‘‘(2) COLLECTION IN SUBSEQUENT YEARS.— 

25 After the fee is paid for the first fiscal year, the fee 


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1 described under this subsection shall be payable on 

2 or before October 1 of each year. 

3 ‘‘(3) ONE FEE PER FACILITY.—The fee shall be 

4 paid only once for each registered exporter for a fis5 cal year in which the fee is payable. 

6 ‘‘(c) FEE AMOUNT.— 

7 ‘‘(1) IN GENERAL.—Subject to subsection 

8 (b)(1), the amount of the fee shall be determined 

9 each year by the Secretary and shall be based on the 

10 anticipated costs to the Secretary of enforcing the 

11 amendments made by the Pharmaceutical Market 

12 Access Act of 2006 in the subsequent fiscal year. 

13 ‘‘(2) LIMITATION.— 

14 ‘‘(A) IN GENERAL.—The aggregate total of 

15 fees collected under this section shall not exceed 

16 1 percent of the total price of drugs exported 

17 annually to the United States by registered ex18 porters under this section. 

19 ‘‘(B) REASONABLE ESTIMATE.—Subject to 

20 the limitation described in subparagraph (A), a 

21 fee under this subsection for an exporter shall 

22 be an amount that is a reasonable estimate by 

23 the Secretary of the annual share of the ex24 porter of the volume of drugs exported by ex25 porters under this section. 


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1 ‘‘(d) USE OF FEES.—The fees collected under this 

2 section shall be used for the sole purpose of administering 

3 this section with respect to registered exporters, including 

4 the costs associated with— 

5 ‘‘(1) inspecting the facilities of registered ex6 porters, and of other entities in the chain of custody 

7 of a qualifying drug; 

8 ‘‘(2) developing, implementing, and maintaining 

9 a system to determine registered exporters’ compli10 ance with the registration conditions the Pharma11 ceutical Market Access Act of 2006, including when 

12 shipments of qualifying drugs are offered for import 

13 into the United States; and 

14 ‘‘(3) inspecting such shipments, as necessary, 

15 when offered for import into the United States to 

16 determine if any such shipment should be refused 

17 admission. 

18 ‘‘(e) ANNUAL FEE SETTING.—The Secretary shall 

19 establish, 60 days before the beginning of each fiscal year 

20 beginning after September 30, 2006, for that fiscal year, 

21 registration fees. 

22 ‘‘(f) EFFECT OF FAILURE TO PAY FEES.— 

23 ‘‘(1) DUE DATE.—A fee payable under this sec24 tion shall be paid by the date that is 30 days after 

25 the date on which the fee is due. 


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1 ‘‘(2) FAILURE TO PAY.—If a registered exporter 

2 subject to a fee under this section fails to pay the 

3 fee, the Secretary shall not permit the registered ex4 porter to engage in exportation to the United States 

5 or offering for exportation prescription drugs under 

6 this Act until all such fees owed by that person are 

7 paid. 

8 ‘‘(g) REPORTS.— 

9 ‘‘(1) FEE ESTABLISHMENT.—Not later than 60 

10 days before the beginning of each fiscal year, the 

11 Secretary shall— 

12 ‘‘(A) publish registration fees under this 

13 section for that fiscal year; 

14 ‘‘(B) hold a meeting at which the public 

15 may comment on the recommendations; and 

16 ‘‘(C) provide for a period of 30 days for 

17 the public to provide written comments on the 

18 recommendations. 

19 ‘‘(2) PERFORMANCE AND FISCAL REPORT.—Be20 ginning with fiscal year 2006, not later than 60 days 

21 after the end of each fiscal year during which fees 

22 are collected under this section, the Secretary shall 

23 submit to the Committee on Health, Education, 

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1 mittee on Energy and Commerce of the House of 

2 Representatives a report that describes— 

3 ‘‘(A) implementation of the registration fee 

4 authority during the fiscal year; and 

5 ‘‘(B) the use by the Secretary of the fees 

6 collected during the fiscal year for which the re7 port is made.’’. 

8 SEC. 206. COUNTERFEIT-RESISTANT TECHNOLOGY. 

9 (a) MISBRANDING.—Section 502 of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 352; deeming 

11 drugs and devices to be misbranded) is amended by adding 

12 at the end the following: 

13 ‘‘(x) If it is a drug subject to section 503(b), unless 

14 the packaging of such drug complies with the require15 ments of section 505C for counterfeit-resistant tech16 nologies.’’. 

17 (b) REQUIREMENTS.—Chapter V of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 

19 is amended by inserting after section 505B the following: 

20 ‘‘SEC. 505C. COUNTERFEIT-RESISTANT TECHNOLOGIES. 

21 ‘‘(a) INCORPORATION OF COUNTERFEIT-RESISTANT

22 TECHNOLOGIES INTO PRESCRIPTION DRUG PACK23 AGING.—The Secretary shall require that the packaging 

24 of any drug subject to section 503(b) incorporate— 


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1 ‘‘(1) overt optically variable counterfeit-resist2 ant technologies that are described in subsection (b) 

3 and comply with the standards of subsection (c); or 

4 ‘‘(2) technologies that have an equivalent func5 tion of security, as determined by the Secretary. 

6 ‘‘(b) ELIGIBLE TECHNOLOGIES.—Technologies de7 scribed in this subsection— 

8 ‘‘(1) shall be visible to the naked eye, providing 

9 for visual identification of product authenticity with10 out the need for readers, microscopes, lighting de11 vices, or scanners; 

12 ‘‘(2) shall be similar to that used by the Bureau 

13 of Engraving and Printing to secure United States 

14 currency; 

15 ‘‘(3) shall be manufactured and distributed in a 

16 highly secure, tightly controlled environment; and 

17 ‘‘(4) should incorporate additional layers of 

18 non-visible covert security features up to and includ19 ing forensic capability. 

20 ‘‘(c) STANDARDS FOR PACKAGING.— 

21 ‘‘(1) MULTIPLE ELEMENTS.—For the purpose 

22 of making it more difficult to counterfeit the pack23 aging of drugs subject to section 503(b), manufac24 turers of the drugs shall incorporate the technologies 

25 described in subsection (b) into multiple elements of 


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1 the physical packaging of the drugs, including blister 

2 packs, shrink wrap, package labels, package seals, 

3 bottles, and boxes. 

4 ‘‘(2) LABELING OF SHIPPING CONTAINER.— 

5 Shipments of drugs described in subsection (a) shall 

6 include a label on the shipping container that incor7 porates the technologies described in subsection (b), 

8 so that officials inspecting the packages will be able 

9 to determine the authenticity of the shipment. Chain 

10 of custody procedures shall apply to such labels and 

11 shall include procedures applicable to contractual 

12 agreements for the use and distribution of the labels, 

13 methods to audit the use of the labels, and database 

14 access for the relevant governmental agencies for 

15 audit or verification of the use and distribution of 

16 the labels. 

17 ‘‘(d) EFFECTIVE DATE.—This section shall take ef18 fect 180 days after the date of enactment of the Pharma19 ceutical Market Access Act of 2006.’’. 

20 SEC. 207. PROHIBITED ACTS. 

21 Section 301 of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 331) is amended by inserting after sub23 section (k) the following: 


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1 ‘‘(l) The failure to register in accordance with section 

2 804(f) or to import or offer to import a prescription drug 

3 in violation of a suspension order under section 804(g).’’. 

4 SEC. 208. PATENTS. 

5 Section 271 of title 35, United States Code, is 

6 amended— 

7 (1) by redesignating subsections (h) and (i) as 

8 subsections (i) and (j), respectively; and 

9 (2) by inserting after subsection (g) the fol10 lowing: 

11 ‘‘(h) It shall not be an act of infringement to use, 

12 offer to sell, or sell within the United States or to import 

13 into the United States any patented invention under sec14 tion 804 (21 U.S.C. 384) of the Federal Food, Drug, and 

15 Cosmetic Act that was first sold abroad by or under au16 thority of the owner or licensee of such patent.’’. 

17 SEC. 209. OTHER ENFORCEMENT ACTIONS. 

18 (a) IN GENERAL.—Section 804 of the Federal Food, 

19 Drug, and Cosmetic Act (as amended in section 4) is 

20 amended by adding at the end the following: 

21 ‘‘(l) UNFAIR OR DISCRIMINATORY ACTS AND PRAC22 TICES.— 

23 ‘‘(1) IN GENERAL.—It is unlawful for a manu24 facturer, directly or indirectly (including by being a 

25 party to a licensing or other agreement) to— 


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1 ‘‘(A) discriminate by charging a higher 

2 price for a prescription drug sold to a person in 

3 a permitted country that exports a prescription 

4 drug to the United States under this section 

5 than the price that is charged to another person 

6 that is in the same country and that does not 

7 export a prescription drug into the United 

8 States under this section; 

9 ‘‘(B) discriminate by charging a higher 

10 price for a prescription drug sold to a person 

11 that distributes, sells, or uses a prescription 

12 drug imported into the United States under 

13 this section than the price that is charged to 

14 another person in the United States that does 

15 not import a prescription drug under this sec16 tion, or that does not distribute, sell, or use 

17 such a drug; 

18 ‘‘(C) discriminate by denying supplies of a 

19 prescription drug to a person in a permitted 

20 country that exports a prescription drug to the 

21 United States under this section or distributes, 

22 sells, or uses a prescription drug imported into 

23 the United States under this section; 

24 ‘‘(D) discriminate by publicly, privately, or 

25 otherwise refusing to do business with a person 


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1 in a permitted country that exports a prescrip2 tion drug to the United States under this sec3 tion or distributes, sells, or uses a prescription 

4 drug imported into the United States under 

5 this section; 

6 ‘‘(E) discriminate by specifically restricting 

7 or delaying the supply of a prescription drug to 

8 a person in a permitted country that exports a 

9 prescription drug to the United States under 

10 this section or distributes, sells, or uses a pre11 scription drug imported into the United States 

12 under this section; 

13 ‘‘(F) cause there to be a difference (includ14 ing a difference in active ingredient, route of 

15 administration, dosage form, strength, formula16 tion, manufacturing establishment, manufac17 turing process, or person that manufactures the 

18 drug) between a prescription drug for distribu19 tion in the United States and the drug for dis20 tribution in a permitted country for the purpose 

21 of restricting importation of the drug into the 

22 United States under this section; 

23 ‘‘(G) refuse to allow an inspection author24 ized under this section of an establishment that 

25 manufactures a prescription drug that may be 


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1 imported or offered for import under this sec2 tion; 

3 ‘‘(H) fail to conform to the methods used 

4 in, or the facilities used for, the manufacturing, 

5 processing, packing, or holding of a prescription 

6 drug that may be imported or offered for im7 port under this section to good manufacturing 

8 practice under this Act; 

9 ‘‘(I) become a party to a licensing or other 

10 agreement related to a prescription drug that 

11 fails to provide for compliance with all require12 ments of this section with respect to such pre13 scription drug or that has the effect of prohib14 iting importation of the drug under this section; 

15 or 

16 ‘‘(J) engage in any other action that the 

17 Federal Trade Commission determines to dis18 criminate against a person that engages in, or 

19 to impede, delay, or block the process for, the 

20 importation of a prescription drug under this 

21 section. 

22 ‘‘(2) AFFIRMATIVE DEFENSE.—It shall be an 

23 affirmative defense to a charge that a person has 

24 discriminated under subparagraph (A), (B), (C), 

25 (D), or (E) of paragraph (1) that the higher price 


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1 charged for a prescription drug sold to a person, the 

2 denial of supplies of a prescription drug to a person, 

3 the refusal to do business with a person, or the spe4 cific restriction or delay of supplies to a person is 

5 not based, in whole or in part, on— 

6 ‘‘(A) the person exporting or importing a 

7 prescription drug into the United States under 

8 this section; or 

9 ‘‘(B) the person distributing, selling, or 

10 using a prescription drug imported into the 

11 United States under this section. 

12 ‘‘(3) PRESUMPTION AND AFFIRMATIVE DE13 FENSE.— 

14 ‘‘(A) PRESUMPTION.—A difference (includ15 ing a difference in active ingredient, route of 

16 administration, dosage form, strength, formula17 tion, manufacturing establishment, manufac18 turing process, or person that manufactures the 

19 drug) created after January 1, 2006, between a 

20 prescription drug for distribution in the United 

21 States and the drug for distribution in a per22 mitted country shall be presumed under para23 graph (1)(H) to be for the purpose of restrict24 ing importation of the drug into the United 

25 States under this section. 


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1 ‘‘(B) AFFIRMATIVE DEFENSE.—It shall be 

2 an affirmative defense to the presumption 

3 under subparagraph (A) that— 

4 ‘‘(i) the difference was required by the 

5 country in which the drug is distributed; or 

6 ‘‘(ii) the Secretary has determined 

7 that the difference was necessary to im8 prove the safety or effectiveness of the 

9 drug. 

10 ‘‘(4) EFFECT OF SUBSECTION.— 

11 ‘‘(A) SALES IN OTHER COUNTRIES.—This 

12 subsection applies only to the sale or distribu13 tion of a prescription drug in a country if the 

14 manufacturer of the drug chooses to sell or dis15 tribute the drug in the country. Nothing in this 

16 subsection shall be construed to compel the 

17 manufacturer of a drug to distribute or sell the 

18 drug in a country. 

19 ‘‘(B) DISCOUNTS TO INSURERS, HEALTH

20 PLANS, PHARMACY BENEFIT MANAGERS, AND

21 COVERED ENTITIES.—Nothing in this sub22 section shall be construed to— 

23 ‘‘(i) prevent or restrict a manufac24 turer of a prescription drug from providing 

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1 macy benefit manager in the United 

2 States, or covered entity in the drug dis3 count program under section 340B in re4 turn for inclusion of the drug on a for5 mulary; 

6 ‘‘(ii) require that such discounts be 

7 made available to other purchasers of the 

8 prescription drug; or 

9 ‘‘(iii) prevent or restrict any other 

10 measures taken by an insurer, health plan, 

11 or pharmacy benefit manager to encourage 

12 consumption of such prescription drug. 

13 ‘‘(C) CHARITABLE CONTRIBUTIONS.— 

14 Nothing in this subsection shall be construed 

15 to— 

16 ‘‘(i) prevent a manufacturer from do17 nating a prescription drug, or supplying a 

18 prescription drug at nominal cost, to a 

19 charitable or humanitarian organization, 

20 including the United Nations and affili21 ates, or to a government of a foreign coun22 try; or 

23 ‘‘(ii) apply to such donations or sup24 plying of a prescription drug. 

25 ‘‘(5) ENFORCEMENT.— 


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1 ‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC2 TICE.—A violation of this subsection shall be 

3 treated as a violation of a rule defining an un4 fair or deceptive act or practice prescribed 

5 under section 18(a)(1)(B) of the Federal Trade 

6 Commission Act. 

7 ‘‘(B) ACTIONS BY THE COMMISSION.—The 

8 Federal Trade Commission— 

9 ‘‘(i) shall enforce this subsection in 

10 the same manner, by the same means, and 

11 with the same jurisdiction, powers, and du12 ties as though all applicable terms and pro13 visions of the Federal Trade Commission 

14 Act were incorporated into and made a 

15 part of this section; and 

16 ‘‘(ii) may seek monetary relief three17 fold the damages sustained. 

18 ‘‘(6) ACTIONS BY STATES.— 

19 ‘‘(A) IN GENERAL.— 

20 ‘‘(i) CIVIL ACTIONS.—The attorney 

21 general of a State may bring a civil action 

22 on behalf of the residents of the State, and 

23 persons doing business in the State, in a 

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1 propriate jurisdiction for a violation of 

2 paragraph (1) to— 

3 ‘‘(I) enjoin that practice; 

4 ‘‘(II) enforce compliance with 

5 this subsection; 

6 ‘‘(III) obtain damages, restitu7 tion, or other compensation on behalf 

8 of residents of the State and persons 

9 doing business in the State, including 

10 threefold the damages; or 

11 ‘‘(IV) obtain such other relief as 

12 the court may consider to be appro13 priate. 

14 ‘‘(ii) NOTICE.— 

15 ‘‘(I) IN GENERAL.—Before filing 

16 an action under clause (i), the attor17 ney general of the State involved shall 

18 provide to the Federal Trade Commis19 sion— 

20 ‘‘(aa) written notice of that 

21 action; and 

22 ‘‘(bb) a copy of the com23 plaint for that action. 

24 ‘‘(II) EXEMPTION.—Subclause 

25 (I) shall not apply with respect to the 


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1 filing of an action by an attorney gen2 eral of a State under this paragraph, 

3 if the attorney general determines 

4 that it is not feasible to provide the 

5 notice described in that subclause be6 fore filing of the action. In such case, 

7 the attorney general of a State shall 

8 provide notice and a copy of the com9 plaint to the Federal Trade Commis10 sion at the same time as the attorney 

11 general files the action. 

12 ‘‘(B) INTERVENTION.— 

13 ‘‘(i) IN GENERAL.—On receiving no14 tice under subparagraph (A)(ii), the Com15 mission shall have the right to intervene in 

16 the action that is the subject of the notice. 

17 ‘‘(ii) EFFECT OF INTERVENTION.—If 

18 the Commission intervenes in an action 

19 under subparagraph (A), it shall have the 

20 right— 

21 ‘‘(I) to be heard with respect to 

22 any matter that arises in that action; 

23 and 

24 ‘‘(II) to file a petition for appeal. 


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1 ‘‘(C) CONSTRUCTION.—For purposes of 

2 bringing any civil action under subparagraph 

3 (A), nothing in this subsection shall be con4 strued to prevent an attorney general of a State 

5 from exercising the powers conferred on the at6 torney general by the laws of that State to— 

7 ‘‘(i) conduct investigations; 

8 ‘‘(ii) administer oaths or affirmations; 

9 or 

10 ‘‘(iii) compel the attendance of wit11 nesses or the production of documentary 

12 and other evidence. 

13 ‘‘(D) ACTIONS BY THE COMMISSION.— 

14 ‘‘(i) IN GENERAL.—In any case in 

15 which an action is instituted by or on be16 half of the Commission for a violation of 

17 paragraph (1), a State may not, during the 

18 pendency of that action, institute an action 

19 under subparagraph (A) for the same vio20 lation against any defendant named in the 

21 complaint in that action. 

22 ‘‘(ii) INTERVENTION.—An attorney 

23 general of a State may intervene, on behalf 

24 of the residents of that State, in an action 

25 instituted by the Commission. 


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1 ‘‘(iii) EFFECT OF INTERVENTION.—If 

2 an attorney general of a State intervenes 

3 in an action instituted by the Commission, 

4 such attorney general shall have the 

5 right— 

6 ‘‘(I) to be heard with respect to 

7 any matter that arises in that action; 

8 and 

9 ‘‘(II) to file a petition for appeal. 

10 ‘‘(E) VENUE.—Any action brought under 

11 subparagraph (A) may be brought in the dis12 trict court of the United States that meets ap13 plicable requirements relating to venue under 

14 section 1391 of title 28, United States Code. 

15 ‘‘(F) SERVICE OF PROCESS.—In an action 

16 brought under subparagraph (A), process may 

17 be served in any district in which the defend18 ant— 

19 ‘‘(i) is an inhabitant; or 

20 ‘‘(ii) may be found. 

21 ‘‘(G) LIMITATION OF ACTIONS.—Any ac22 tion under this paragraph to enforce a cause of 

23 action under this subsection by the Federal 

24 Trade Commission or the attorney general of a 

25 State shall be forever barred unless commenced 


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1 within 5 years after the Federal Trade Commis2 sion, or the attorney general, as the case may 

3 be, knew or should have known that the cause 

4 of action accrued. No cause of action barred 

5 under existing law on the effective date of the 

6 Pharmaceutical Market Access Act of 2006 

7 shall be revived by such Act. 

8 ‘‘(H) MEASUREMENT OF DAMAGES.—In 

9 any action under this paragraph to enforce a 

10 cause of action under this subsection in which 

11 there has been a determination that a defend12 ant has violated a provision of this subsection, 

13 damages may be proved and assessed in the ag14 gregate by statistical or sampling methods, by 

15 the computation of illegal overcharges or by 

16 such other reasonable system of estimating ag17 gregate damages as the court in its discretion 

18 may permit without the necessity of separately 

19 proving the individual claim of, or amount of 

20 damage to, persons on whose behalf the suit 

21 was brought. 

22 ‘‘(I) EXCLUSION ON DUPLICATIVE RE23 LIEF.—The district court shall exclude from the 

24 amount of monetary relief awarded in an action 

25 under this paragraph brought by the attorney 


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1 general of a State any amount of monetary re2 lief which duplicates amounts which have been 

3 awarded for the same injury. 

4 ‘‘(7) EFFECT ON ANTITRUST LAWS.—Nothing 

5 in this subsection shall be construed to modify, im6 pair, or supersede the operation of the antitrust 

7 laws. For the purpose of this subsection, the term 

8 ‘antitrust laws’ has the meaning given it in the first 

9 section of the Clayton Act, except that it includes 

10 section 5 of the Federal Trade Commission Act to 

11 the extent that such section 5 applies to unfair 

12 methods of competition. 

13 ‘‘(8) MANUFACTURER.—In this subsection, the 

14 term ‘manufacturer’ means any entity, including any 

15 affiliate or licensee of that entity, that is engaged 

16 in— 

17 ‘‘(A) the production, preparation, propaga18 tion, compounding, conversion, or processing of 

19 a prescription drug, either directly or indirectly 

20 by extraction from substances of natural origin, 

21 or independently by means of chemical syn22 thesis, or by a combination of extraction and 

23 chemical synthesis; or 


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1 ‘‘(B) the packaging, repackaging, labeling, 

2 relabeling, or distribution of a prescription 

3 drug.’’. 

4 (b) REGULATIONS.—The Federal Trade Commission 

5 shall promulgate regulations to carry out the enforcement 

6 program under section 804(l) of the Federal Food, Drug, 

7 and Cosmetic Act (as added by subsection (a)). 

8 (c) SUSPENSION AND TERMINATION OF EXPORT9 ERS.—Section 804(g) of the Federal Food, Drug, and 

10 Cosmetic Act (as amended by section 304(g)) (21 U.S.C. 

11 384(g)) is amended by— 

12 (1) striking ‘‘(g) SUSPENSION OF IMPORTA13 TION.—The Secretary’’ and inserting 

14 ‘‘(g) SUSPENSION OF IMPORTATION.— 

15 ‘‘(1) IN GENERAL.—The Secretary’’; and 

16 (2) adding at the end the following: 

17 ‘‘(2) SUSPENSION AND TERMINATION OF EX18 PORTERS.— 

19 ‘‘(A) SUSPENSION.—With respect to the 

20 effectiveness of a registration submitted under 

21 subsection (f) by a registered exporter: 

22 ‘‘(i) Subject to clause (ii), if the Sec23 retary determines, after notice and oppor24 tunity for a hearing, that the registered ex25 porter has failed to maintain substantial 

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1 compliance with all registration conditions, 

2 the Secretary may suspend the registra3 tion. 

4 ‘‘(ii) If the Secretary determines that, 

5 under color of the registration, the reg6 istered exporter has exported a drug that 

7 is not a qualifying drug, or a drug that 

8 does not meet the criteria under this sec9 tion, or has exported a qualifying drug to 

10 an individual in violation of this section, 

11 the Secretary shall immediately suspend 

12 the registration. A suspension under the 

13 preceding sentence is not subject to the 

14 provision by the Secretary of prior notice, 

15 and the Secretary shall provide to the reg16 istered exporter involved an opportunity 

17 for a hearing not later than 10 days after 

18 the date on which the registration is sus19 pended. 

20 ‘‘(iii) The Secretary may reinstate the 

21 registration, whether suspended under 

22 clause (i) or (ii), if the Secretary deter23 mines that the registered exporter has 

24 demonstrated that further violations of 

25 registration conditions will not occur. 


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1 ‘‘(B) TERMINATION.—The Secretary, after 

2 notice and opportunity for a hearing, may ter3 minate the registration under subsection (f) of 

4 a registered exporter if the Secretary deter5 mines that the registered exporter has engaged 

6 in a pattern or practice of violating 1 or more 

7 registration conditions, or if on 1 or more occa8 sions the Secretary has under subparagraph 

9 (A)(ii) suspended the registration of the reg10 istered exporter. The Secretary may make the 

11 termination permanent, or for a fixed period of 

12 not less than 1 year. During the period in 

13 which the registration of a registered exporter 

14 is terminated, any registration submitted under 

15 subsection (f) by such exporter or a person who 

16 is a partner in the export enterprise or a prin17 cipal officer in such enterprise, and any reg18 istration prepared with the assistance of such 

19 exporter or such a person, has no legal effect 

20 under this section.’’. 

21 SEC. 210. AUTHORIZATION OF APPROPRIATIONS. 

22 There are authorized to be appropriated such sums 

23 as may be necessary to carry out this title (and the amend24 ments made by this title). 


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1 TITLE III—EXTENSION OF 2006 

2 ENROLLMENT PERIOD 

3 SEC. 301. EXTENSION OF 2006 ANNUAL COORDINATED 

4 ELECTION PERIOD FOR MEDICARE PRE5 SCRIPTION DRUG BENEFIT; SUSPENSION OF 

6 LATE ENROLLMENT PENALTIES THROUGH 

7 DECEMBER 31, 2006. 

8 (a) EXTENSION OF 2006 ANNUAL COORDINATED

9 ELECTION PERIOD FOR MEDICARE PRESCRIPTION DRUG

10 BENEFIT.— 

11 (1) FOR MEDICARE PRESCRIPTION DRUG

12 PLANS.—Section 1860D–1(b)(1)(B)(iii) of the Social 

13 Security Act (42 U.S.C. 1395w–101(b)(1)(B)(iii)) is 

14 amended by inserting ‘‘, except that in applying 

15 paragraph (1) of such section, with respect to the 

16 annual coordinated election period for 2006, such 

17 period shall continue through November 14, 2006’’ 

18 before the period. 

19 (2) APPLICATION TO MA–PD PLANS.—Section 

20 1851(e)(3)(B)(iii) of such Act (42 U.S.C. 1395w– 

21 21(e)(3)(B)(iii)) is amended by inserting ‘‘, except 

22 that in the case of an MA–PD plan, such period 

23 shall continue through November 14, 2006’’ after 

24 ‘‘May 15, 2006’’. 


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1 (b) SUSPENSION OF LATE ENROLLMENT PENALTIES

2 THROUGH DECEMBER 31, 2006.—Section 1860D– 

3 13(b)(3)(B) of the Social Security Act (42 U.S.C. 1395w– 

4 113(b)(3)(B)) is amended by inserting ‘‘after December 

5 2006 and’’ after ‘‘any month beginning’’. 

Æ 


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