I 

109TH CONGRESS 

1ST SESSION H. R. 328

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

importation of prescription drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 25, 2005

Mr. GUTKNECHT (for himself, Mr. EMANUEL, Mrs. EMERSON, Mr. SANDERS, 

Ms. DELAURO, Mrs. NORTHUP, Mr. BURTON of Indiana, Ms. GINNY

BROWN-WAITE of Florida, Mr. JONES of North Carolina, Mr. BROWN of 

Ohio, Mr. ISTOOK, Mr. KINGSTON, Mr. RAMSTAD, Mr. KING of Iowa, and 

Mr. LANGEVIN) introduced the following bill; which was referred to the 

Committee on Energy and Commerce, and in addition to the Committee 

on the 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 amend the Federal Food, Drug, and Cosmetic Act with 

respect to the importation of prescription drugs, 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 ‘‘Pharmaceutical Mar5 ket Access Act of 2005’’. 
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1 SEC. 2. FINDINGS. 

2 Congress finds as follows: 

3 (1) Americans unjustly pay up to 1000 percent 

4 more to fill their prescriptions than consumers in 

5 other countries. 

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

7 market for pharmaceuticals yet consumers still pay 

8 the world’s highest prices. 

9 (3) An unaffordable drug is neither safe nor ef10 fective. Allowing and structuring the importation of 

11 prescription drugs ensures access to affordable 

12 drugs, thus providing a level of safety to American 

13 consumers they do not currently enjoy. 

14 (4) According to the Congressional Budget Of15 fice, American seniors alone will spend 

16 $1,800,000,000,000 on pharmaceuticals over the 

17 next 10 years. 

18 (5) Allowing open pharmaceutical markets 

19 could save American consumers at least 

20 $635,000,000,000 of their own money. 

21 SEC. 3. PURPOSES. 

22 The purposes of this Act are as follows: 

23 (1) To give all Americans immediate relief from 

24 the outrageously high cost of pharmaceuticals. 

25 (2) To reverse the perverse economics of the 

26 American pharmaceutical market. 
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1 (3) To allow the importation of prescription 

2 drugs only if the drugs and facilities where such 

3 drugs are manufactured are approved by the Food 

4 and Drug Administration, and to exclude pharma5 ceutical narcotics. 

6 (4) To require that imported prescription drugs 

7 be packaged and shipped using counterfeit-resistant 

8 technologies. 

9 SEC. 4. AMENDMENTS TO SECTION 804 OF THE FEDERAL 

10 FOOD, DRUG, AND COSMETIC. 

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

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

13 amended to read as follows: 

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

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

16 pharmacy, group of pharmacies, pharmacist, or 

17 wholesaler. 

18 ‘‘(2) PERMITTED COUNTRY.—The term ‘per19 mitted country’ means a country, union, or economic 

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

21 802(b)(1) (as of December 31, 2003), except that 

22 the Secretary—

23 ‘‘(A) may add a country, union, or eco24 nomic area to such list for purposes of this sec25 tion if the Secretary determines that the coun-
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1 try, union, or economic area has a pharma2 ceutical infrastructure that is substantially 

3 equivalent or superior to the pharmaceutical in4 frastructure of the United States, taking into 

5 consideration pharmacist qualifications, phar6 macy storage procedures, the drug distribution 

7 system, the drug dispensing system, and market 

8 regulation; and 

9 ‘‘(B) may remove a country, union, or eco10 nomic area from such list for purposes of this 

11 section if the Secretary determines that the 

12 country, union, or economic area does not have 

13 such a pharmaceutical infrastructure. 

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

15 means a person licensed by the relevant govern16 mental authority to practice pharmacy, including the 

17 dispensing and selling of prescription drugs. 

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

19 a person that is licensed by the relevant govern20 mental authority to engage in the business of selling 

21 prescription drugs that employs 1 or more phar22 macists. 

23 ‘‘(5) PRESCRIPTION DRUG.—The term ‘pre24 scription drug’ means a drug subject to section 

25 503(b), other than—
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1 ‘‘(A) a controlled substance (as defined in 

2 section 102 of the Controlled Substances Act 

3 (21 U.S.C. 802)); 

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

5 section 351 of the Public Health Service Act 

6 (42 U.S.C. 262)); 

7 ‘‘(C) an infused drug (including a peri8 toneal dialysis solution); 

9 ‘‘(D) an intravenously injected drug; 

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

11 or 

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

13 the importation of which pursuant to subsection 

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

15 threat to the public health, in which case sec16 tion 801(d)(1) shall continue to apply. 

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

18 drug’ means a prescription drug that—

19 ‘‘(A) is approved pursuant to an applica20 tion submitted under section 505(b)(1); and 

21 ‘‘(B) is not—

22 ‘‘(i) a drug manufactured through 1 

23 or more biotechnology processes; 

24 ‘‘(ii) a drug that is required to be re25 frigerated; or 
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1 ‘‘(iii) a photoreactive drug. 

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

3 term ‘qualifying Internet pharmacy’ means a reg4 istered exporter that dispenses qualifying drugs to 

5 individuals over an Internet website. 

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

7 ‘qualifying laboratory’ means a laboratory in the 

8 United States that has been approved by the Sec9 retary for the purposes of this section. 

10 ‘‘(9) REGISTERED EXPORTER.—The term ‘reg11 istered exporter’ means a person that is in the busi12 ness of exporting a drug to persons in the United 

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

14 which a registration under this section has been ap15 proved and is in effect. 

16 ‘‘(10) WHOLESALER.—

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

18 means a person licensed as a wholesaler or dis19 tributor of prescription drugs in the United 

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

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

22 does not include a person authorized to import 

23 drugs under section 801(d)(1).’’. 
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1 (b) REGULATIONS.—Section 804(b) of the Federal 

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

3 amended to read as follows: 

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

5 the date of enactment of the Pharmaceutical Market Ac6 cess Act of 2005, the Secretary, after consultation with 

7 the United States Trade Representative and the Commis8 sioner of Customs, shall promulgate regulations permit9 ting pharmacists, pharmacies, and wholesalers to import 

10 qualifying drugs from permitted countries into the United 

11 States.’’. 

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

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

14 amended by striking ‘‘prescription drug’’ each place it ap15 pears and inserting ‘‘qualifying drug’’. 

16 (d) INFORMATION AND RECORDS.—Section 

17 804(d)(1) of the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 384(d)(1)) is amended—

19 (1) by striking subparagraph (G) and redesig20 nating subparagraphs (H) through (N) as subpara21 graphs (G) through (M), respectively; 

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

23 by striking ‘‘telephone number, and professional li24 cense number (if any)’’ and inserting ‘‘and telephone 

25 number’’; and 
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1 (3) in subparagraph (L) (as so redesignated), 

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

3 (K)’’. 

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

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

6 to read as follows: 

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

8 shall require that the testing described under subpara9 graphs (I) and (K) of subsection (d)(1) be conducted by 

10 the importer of the qualifying drug, unless the qualifying 

11 drug is subject to the requirements under section 505C 

12 for counterfeit-resistant technologies.’’. 

13 (f) REGISTRATION OF EXPORTERS; INSPECTIONS.—

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

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

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

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

18 be a registered exporter (referred to in this sub19 section as the ‘registrant’) shall submit to the Sec20 retary a registration that includes the following: 

21 ‘‘(A) The name of the registrant and iden22 tification of all places of business of the reg23 istrant that relate to qualifying drugs, including 

24 each warehouse or other facility owned or con25 trolled by, or operated for, the registrant; 
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1 ‘‘(B) An agreement by the registrant to—

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

3 relate to qualifying drugs (including ware4 houses and other facilities owned or con5 trolled by, or operated for, the exporter) 

6 and records available to the Secretary for 

7 on-site inspections, without prior notice, 

8 for the purpose of determining whether the 

9 registrant is in compliance with this Act’s 

10 requirements; 

11 ‘‘(ii) export only qualifying drugs; 

12 ‘‘(iii) export only to persons author13 ized to import the drugs; 

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

15 or withdrawal of a qualifying drug distrib16 uted in a permitted country to or from 

17 which the registrant has exported or im18 ported, or intends to export or import, to 

19 the United States; 

20 ‘‘(v) monitor compliance with registra21 tion conditions and report any noncompli22 ance promptly; 

23 ‘‘(vi) submit a compliance plan show24 ing how the registrant will correct viola25 tions, if any; and 
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1 ‘‘(vii) promptly notify the Secretary of 

2 changes in the registration information of 

3 the registrant. 

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

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

6 days after receiving a completed registration 

7 from a registrant, the Secretary shall—

8 ‘‘(i) notify such registrant of receipt 

9 of the registration; 

10 ‘‘(ii) assign such registrant a registra11 tion number; and 

12 ‘‘(ii) approve or disapprove the appli13 cation. 

14 ‘‘(B) DISAPPROVAL OF APPLICATION.—

15 ‘‘(i) IN GENERAL.—The Secretary 

16 shall disapprove a registration, and notify 

17 the registrant of such disapproval, if the 

18 Secretary has reason to believe that such 

19 registrant is not in compliance with a reg20 istration condition. 

21 ‘‘(ii) SUBSEQUENT APPROVAL.—The 

22 Secretary may subsequently approve a reg23 istration that was denied under clause (i) 

24 if the Secretary finds that the registrant is 
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1 in compliance with all registration condi2 tions. 

3 ‘‘(3) LIST.—The Secretary shall—

4 ‘‘(A) maintain an up-to-date list of reg5 istered exporters (including qualifying Internet 

6 pharmacies that sell qualifying drugs to individ7 uals); 

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

9 on the Internet site of the Food and Drug Ad10 ministration and via a toll-free telephone num11 ber; and 

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

13 approval of a registration under this subsection. 

14 ‘‘(4) EDUCATION OF CONSUMERS.—The Sec15 retary shall carry out activities, by use of the Inter16 net website and toll-free telephone number under 

17 paragraph (3), that educate consumers with regard 

18 to the availability of qualifying drugs for import for 

19 personal use under this section, including informa20 tion on how to verify whether an exporter is reg21 istered. 

22 ‘‘(5) INSPECTION OF IMPORTERS AND REG23 ISTERED EXPORTERS.—The Secretary shall inspect 

24 the warehouses, other facilities, and records of im25 porters and registered exporters as often as the Sec-
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1 retary determines necessary to ensure that such im2 porters and registered exporters are in compliance 

3 with this section.’’. 

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

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

6 384(g)) is amended by—

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

8 the public is adequately protected from counterfeit 

9 and violative prescription drugs being imported 

10 under subsection (b)’’; and 

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

12 following: ‘‘The Secretary shall reinstate the impor13 tation by a specific importer upon a determination 

14 by the Secretary that the violation has been cor15 rected and that the importer has demonstrated that 

16 further violations will not occur. This subsection 

17 shall not apply to a prescription drug imported by 

18 an individual, or to a prescription drug shipped to 

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

20 (h) WAIVER AUTHORITY FOR INDIVIDUALS.—Section 

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

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

23 ‘‘(j) IMPORTATION BY INDIVIDUALS.—

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

25 after the enactment of the Pharmaceutical Market 
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1 Access Act of 2005, the Secretary shall by regula2 tion permit an individual to import a drug from a 

3 permitted country to the United States if the drug 

4 is—

5 ‘‘(A) a qualifying drug; 

6 ‘‘(B) imported from a licensed pharmacy 

7 or qualifying Internet pharmacy; 

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

9 family member of the individual, not for resale; 

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

11 90-day supply during any 90-day period; and 

12 ‘‘(E) accompanied by a copy of a prescrip13 tion for the drug, which—

14 ‘‘(i) is valid under applicable Federal 

15 and State laws; and 

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

17 is authorized to administer prescription 

18 drugs. 

19 ‘‘(2) DRUGS DISPENSED OUTSIDE THE UNITED

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

21 country that is not a permitted country if—

22 ‘‘(A) the drug was dispensed to the indi23 vidual while the individual was in such country, 

24 and the drug was dispensed in accordance with 

25 the laws and regulations of such country; 
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1 ‘‘(B) the individual is entering the United 

2 States and the drug accompanies the individual 

3 at the time of entry; 

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

5 distribution in the country in which the drug 

6 was obtained; 

7 ‘‘(D) the drug does not appear to be adul8 terated; and 

9 ‘‘(E) the quantity of the drug does not ex10 ceed a 14-day supply.’’. 

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

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

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

14 SEC. 5. REGISTRATION FEES. 

15 Subchapter C of chapter VII of the Federal Food, 

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

17 amended by adding at the end the following: 

18 ‘‘PART 5—FEES RELATING TO PRESCRIPTION 

19 DRUG IMPORTATION 

20 ‘‘SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IM21 PORTATION. 

22 ‘‘(a) REGISTRATION FEE.—The Secretary shall es23 tablish a registration fee program under which a reg24 istered exporter under section 804 shall be required to pay 
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1 an annual fee to the Secretary in accordance with this sub2 section. 

3 ‘‘(b) COLLECTION.—

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

5 A fee under this section shall be payable for the fis6 cal year in which the registered exporter first sub7 mits a registration under section 804 (or reregisters 

8 under that section if that person has withdrawn its 

9 registration and subsequently reregisters) in a 

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

11 first submits a registration to the Secretary under 

12 section 804. 

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

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

15 described under this subsection shall be payable on 

16 or before October 1 of each year. 

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

18 paid only once for each registered exporter for a fis19 cal year in which the fee is payable. 

20 ‘‘(c) FEE AMOUNT.—

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

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

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

24 anticipated costs to the Secretary of enforcing the 
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1 amendments made by the Pharmaceutical Market 

2 Access Act of 2005 in the subsequent fiscal year. 

3 ‘‘(2) LIMITATION.—

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

5 fees collected under this section shall not exceed 

6 1 percent of the total price of drugs exported 

7 annually to the United States by registered ex8 porters under this section. 

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

10 the limitation described in subparagraph (A), a 

11 fee under this subsection for an exporter shall 

12 be an amount that is a reasonable estimate by 

13 the Secretary of the annual share of the ex14 porter of the volume of drugs exported by ex15 porters under this section. 

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

17 section shall be used for the sole purpose of administering 

18 this section with respect to registered exporters, including 

19 the costs associated with—

20 ‘‘(1) inspecting the facilities of registered ex21 porters, and of other entities in the chain of custody 

22 of a qualifying drug; 

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

24 a system to determine registered exporters’ compli25 ance with the registration conditions under the 
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1 Pharmaceutical Market Access Act of 2005, includ2 ing when shipments of qualifying drugs are offered 

3 for import into the United States; and 

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

5 when offered for import into the United States to 

6 determine if any such shipment should be refused 

7 admission. 

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

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

10 beginning after September 30, 2005, for that fiscal year, 

11 registration fees. 

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

13 ‘‘(1) DUE DATE.—A fee payable under this sec14 tion shall be paid by the date that is 30 days after 

15 the date on which the fee is due. 

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

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

18 fee, the Secretary shall not permit the registered ex19 porter to engage in exportation to the United States 

20 or offering for exportation prescription drugs under 

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

22 paid. 

23 ‘‘(g) REPORTS.—
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1 ‘‘(1) FEE ESTABLISHMENT.—Not later than 60 

2 days before the beginning of each fiscal year, the 

3 Secretary shall—

4 ‘‘(A) publish registration fees under this 

5 section for that fiscal year; 

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

7 may comment on the recommendations; and 

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

9 the public to provide written comments on the 

10 recommendations. 

11 ‘‘(2) PERFORMANCE AND FISCAL REPORT.—Be12 ginning with fiscal year 2005, not later than 60 days 

13 after the end of each fiscal year during which fees 

14 are collected under this section, the Secretary shall 

15 submit to the Committee on Health, Education, 

16 Labor, and Pensions of the Senate and the Com17 mittee on Energy and Commerce of the House of 

18 Representatives a report that describes—

19 ‘‘(A) implementation of the registration fee 

20 authority during the fiscal year; and 

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

22 collected during the fiscal year for which the re23 port is made.’’. 
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1 SEC. 6. COUNTERFEIT-RESISTANT TECHNOLOGY. 

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

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

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

5 at the end the following: 

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

7 the packaging of such drug complies with the require8 ments of section 505C for counterfeit-resistant tech9 nologies.’’. 

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

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

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

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

14 ‘‘(a) INCORPORATION OF COUNTERFEIT-RESISTANT

15 TECHNOLOGIES INTO PRESCRIPTION DRUG PACK16 AGING.—The Secretary shall require that the packaging 

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

18 ‘‘(1) overt optically variable counterfeit-resist19 ant technologies that are described in subsection (b) 

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

21 ‘‘(2) technologies that have an equivalent func22 tion of security, as determined by the Secretary. 

23 ‘‘(b) ELIGIBLE TECHNOLOGIES.—Technologies de24 scribed in this subsection—

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

26 for visual identification of product authenticity with-
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1 out the need for readers, microscopes, lighting de2 vices, or scanners; 

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

4 of Engraving and Printing to secure United States 

5 currency; 

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

7 highly secure, tightly controlled environment; and 

8 ‘‘(4) should incorporate additional layers of 

9 non-visible covert security features up to and includ10 ing forensic capability. 

11 ‘‘(c) STANDARDS FOR PACKAGING.—

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

13 of making it more difficult to counterfeit the pack14 aging of drugs subject to section 503(b), manufac15 turers of the drugs shall incorporate the technologies 

16 described in subsection (b) into multiple elements of 

17 the physical packaging of the drugs, including blister 

18 packs, shrink wrap, package labels, package seals, 

19 bottles, and boxes. 

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

21 Shipments of drugs described in subsection (a) shall 

22 include a label on the shipping container that incor23 porates the technologies described in subsection (b), 

24 so that officials inspecting the packages will be able 

25 to determine the authenticity of the shipment. Chain 
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1 of custody procedures shall apply to such labels and 

2 shall include procedures applicable to contractual 

3 agreements for the use and distribution of the labels, 

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

5 access for the relevant governmental agencies for 

6 audit or verification of the use and distribution of 

7 the labels. 

8 ‘‘(d) EFFECTIVE DATE.—This section shall take ef9 fect 180 days after the date of enactment of the Pharma10 ceutical Market Access Act of 2005.’’. 

11 SEC. 7. PROHIBITED ACTS. 

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

13 Act (21 U.S.C. 331) is amended by inserting after sub14 section (k) the following: 

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

16 804(f) or to import or offer to import a prescription drug 

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

18 SEC. 8. PATENTS. 

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

20 amended—

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

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

23 (2) by inserting after subsection (g) the fol24 lowing: 
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1 ‘‘(h) It shall not be an act of infringement to use, 

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

3 into the United States any patented invention under sec4 tion 804 (21 U.S.C. 384) of the Federal Food, Drug, and 

5 Cosmetic Act that was first sold abroad by or under au6 thority of the owner or licensee of such patent.’’. 

7 SEC. 9. OTHER ENFORCEMENT ACTIONS. 

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

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

10 amended by adding at the end the following: 

11 ‘‘(l) UNFAIR OR DISCRIMINATORY ACTS AND PRAC12 TICES.—

13 ‘‘(1) IN GENERAL.—It is unlawful for a manu14 facturer, directly or indirectly (including by being a 

15 party to a licensing or other agreement) to—

16 ‘‘(A) discriminate by charging a higher 

17 price for a prescription drug sold to a person in 

18 a permitted country that exports a prescription 

19 drug to the United States under this section 

20 than the price that is charged to another person 

21 that is in the same country and that does not 

22 export a prescription drug into the United 

23 States under this section; 

24 ‘‘(B) discriminate by charging a higher 

25 price for a prescription drug sold to a person 
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1 that distributes, sells, or uses a prescription 

2 drug imported into the United States under 

3 this section than the price that is charged to 

4 another person in the United States that does 

5 not import a prescription drug under this sec6 tion, or that does not distribute, sell, or use 

7 such a drug; 

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

9 prescription drug to a person in a permitted 

10 country that exports a prescription drug to the 

11 United States under this section or distributes, 

12 sells, or uses a prescription drug imported into 

13 the United States under this section; 

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

15 otherwise refusing to do business with a person 

16 in a permitted country that exports a prescrip17 tion drug to the United States under this sec18 tion or distributes, sells, or uses a prescription 

19 drug imported into the United States under 

20 this section; 

21 ‘‘(E) discriminate by specifically restricting 

22 or delaying the supply of a prescription drug to 

23 a person in a permitted country that exports a 

24 prescription drug to the United States under 

25 this section or distributes, sells, or uses a pre-
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1 scription drug imported into the United States 

2 under this section; 

3 ‘‘(F) cause there to be a difference (includ4 ing a difference in active ingredient, route of 

5 administration, dosage form, strength, formula6 tion, manufacturing establishment, manufac7 turing process, or person that manufactures the 

8 drug) between a prescription drug for distribu9 tion in the United States and the drug for dis10 tribution in a permitted country for the purpose 

11 of restricting importation of the drug into the 

12 United States under this section; 

13 ‘‘(G) refuse to allow an inspection author14 ized under this section of an establishment that 

15 manufactures a prescription drug that may be 

16 imported or offered for import under this sec17 tion; 

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

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

20 processing, packing, or holding of a prescription 

21 drug that may be imported or offered for im22 port under this section to good manufacturing 

23 practice under this Act; 

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

25 agreement related to a prescription drug that 
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1 fails to provide for compliance with all require2 ments of this section with respect to such pre3 scription drug or that has the effect of prohib4 iting importation of the drug under this section; 

5 or 

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

7 Federal Trade Commission determines to dis8 criminate against a person that engages in, or 

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

10 importation of a prescription drug under this 

11 section. 

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

13 affirmative defense to a charge that a person has 

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

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

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

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

18 the refusal to do business with a person, or the spe19 cific restriction or delay of supplies to a person is 

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

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

22 prescription drug into the United States under 

23 this section; or 
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1 ‘‘(B) the person distributing, selling, or 

2 using a prescription drug imported into the 

3 United States under this section. 

4 ‘‘(3) PRESUMPTION AND AFFIRMATIVE DE5 FENSE.—

6 ‘‘(A) PRESUMPTION.—A difference (includ7 ing a difference in active ingredient, route of 

8 administration, dosage form, strength, formula9 tion, manufacturing establishment, manufac10 turing process, or person that manufactures the 

11 drug) created after January 1, 2005, between a 

12 prescription drug for distribution in the United 

13 States and the drug for distribution in a per14 mitted country shall be presumed under para15 graph (1)(H) to be for the purpose of restrict16 ing importation of the drug into the United 

17 States under this section. 

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

19 an affirmative defense to the presumption 

20 under subparagraph (A) that—

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

22 country in which the drug is distributed; or 

23 ‘‘(ii) the Secretary has determined 

24 that the difference was necessary to im-
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•HR 328 IH 

1 prove the safety or effectiveness of the 

2 drug. 

3 ‘‘(4) EFFECT OF SUBSECTION.—

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

5 subsection applies only to the sale or distribu6 tion of a prescription drug in a country if the 

7 manufacturer of the drug chooses to sell or dis8 tribute the drug in the country. Nothing in this 

9 subsection shall be construed to compel the 

10 manufacturer of a drug to distribute or sell the 

11 drug in a country. 

12 ‘‘(B) DISCOUNTS TO INSURERS, HEALTH

13 PLANS, PHARMACY BENEFIT MANAGERS, AND

14 COVERED ENTITIES.—Nothing in this sub15 section shall be construed to—

16 ‘‘(i) prevent or restrict a manufac17 turer of a prescription drug from providing 

18 discounts to an insurer, health plan, phar19 macy benefit manager in the United 

20 States, or covered entity in the drug dis21 count program under section 340B in re22 turn for inclusion of the drug on a for23 mulary; 
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•HR 328 IH 

1 ‘‘(ii) require that such discounts be 

2 made available to other purchasers of the 

3 prescription drug; or 

4 ‘‘(iii) prevent or restrict any other 

5 measures taken by an insurer, health plan, 

6 or pharmacy benefit manager to encourage 

7 consumption of such prescription drug. 

8 ‘‘(C) CHARITABLE CONTRIBUTIONS.—

9 Nothing in this subsection shall be construed 

10 to—

11 ‘‘(i) prevent a manufacturer from do12 nating a prescription drug, or supplying a 

13 prescription drug at nominal cost, to a 

14 charitable or humanitarian organization, 

15 including the United Nations and affili16 ates, or to a government of a foreign coun17 try; or 

18 ‘‘(ii) apply to such donations or sup19 plying of a prescription drug. 

20 ‘‘(5) ENFORCEMENT.—

21 ‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC22 TICE.—A violation of this subsection shall be 

23 treated as a violation of a rule defining an un24 fair or deceptive act or practice prescribed 
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•HR 328 IH 

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

2 Commission Act. 

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

4 Federal Trade Commission—

5 ‘‘(i) shall enforce this subsection in 

6 the same manner, by the same means, and 

7 with the same jurisdiction, powers, and du8 ties as though all applicable terms and pro9 visions of the Federal Trade Commission 

10 Act were incorporated into and made a 

11 part of this section; and 

12 ‘‘(ii) may seek monetary relief three13 fold the damages sustained. 

14 ‘‘(6) ACTIONS BY STATES.—

15 ‘‘(A) IN GENERAL.—

16 ‘‘(i) CIVIL ACTIONS.—The attorney 

17 general of a State may bring a civil action 

18 on behalf of the residents of the State, and 

19 persons doing business in the State, in a 

20 district court of the United States of ap21 propriate jurisdiction for a violation of 

22 paragraph (1) to—

23 ‘‘(I) enjoin that practice; 

24 ‘‘(II) enforce compliance with 

25 this subsection; 
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•HR 328 IH 

1 ‘‘(III) obtain damages, restitu2 tion, or other compensation on behalf 

3 of residents of the State and persons 

4 doing business in the State, including 

5 threefold the damages; or 

6 ‘‘(IV) obtain such other relief as 

7 the court may consider to be appro8 priate. 

9 ‘‘(ii) NOTICE.—

10 ‘‘(I) IN GENERAL.—Before filing 

11 an action under clause (i), the attor12 ney general of the State involved shall 

13 provide to the Federal Trade Commis14 sion—

15 ‘‘(aa) written notice of that 

16 action; and 

17 ‘‘(bb) a copy of the com18 plaint for that action. 

19 ‘‘(II) EXEMPTION.—Subclause 

20 (I) shall not apply with respect to the 

21 filing of an action by an attorney gen22 eral of a State under this paragraph, 

23 if the attorney general determines 

24 that it is not feasible to provide the 

25 notice described in that subclause be-
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•HR 328 IH 

1 fore filing of the action. In such case, 

2 the attorney general of a State shall 

3 provide notice and a copy of the com4 plaint to the Federal Trade Commis5 sion at the same time as the attorney 

6 general files the action. 

7 ‘‘(B) INTERVENTION.—

8 ‘‘(i) IN GENERAL.—On receiving no9 tice under subparagraph (A)(ii), the Com10 mission shall have the right to intervene in 

11 the action that is the subject of the notice. 

12 ‘‘(ii) EFFECT OF INTERVENTION.—If 

13 the Commission intervenes in an action 

14 under subparagraph (A), it shall have the 

15 right—

16 ‘‘(I) to be heard with respect to 

17 any matter that arises in that action; 

18 and 

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

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

21 bringing any civil action under subparagraph 

22 (A), nothing in this subsection shall be con23 strued to prevent an attorney general of a State 

24 from exercising the powers conferred on the at25 torney general by the laws of that State to—
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•HR 328 IH 

1 ‘‘(i) conduct investigations; 

2 ‘‘(ii) administer oaths or affirmations; 

3 or 

4 ‘‘(iii) compel the attendance of wit5 nesses or the production of documentary 

6 and other evidence. 

7 ‘‘(D) ACTIONS BY THE COMMISSION.—

8 ‘‘(i) IN GENERAL.—In any case in 

9 which an action is instituted by or on be10 half of the Commission for a violation of 

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

12 pendency of that action, institute an action 

13 under subparagraph (A) for the same vio14 lation against any defendant named in the 

15 complaint in that action. 

16 ‘‘(ii) INTERVENTION.—An attorney 

17 general of a State may intervene, on behalf 

18 of the residents of that State, in an action 

19 instituted by the Commission. 

20 ‘‘(iii) EFFECT OF INTERVENTION.—If 

21 an attorney general of a State intervenes 

22 in an action instituted by the Commission, 

23 such attorney general shall have the 

24 right—
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•HR 328 IH 

1 ‘‘(I) to be heard with respect to 

2 any matter that arises in that action; 

3 and 

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

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

6 subparagraph (A) may be brought in the dis7 trict court of the United States that meets ap8 plicable requirements relating to venue under 

9 section 1391 of title 28, United States Code. 

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

11 brought under subparagraph (A), process may 

12 be served in any district in which the defend13 ant—

14 ‘‘(i) is an inhabitant; or 

15 ‘‘(ii) may be found. 

16 ‘‘(G) LIMITATION OF ACTIONS.—Any ac17 tion under this paragraph to enforce a cause of 

18 action under this subsection by the Federal 

19 Trade Commission or the attorney general of a 

20 State shall be forever barred unless commenced 

21 within 5 years after the Federal Trade Commis22 sion, or the attorney general, as the case may 

23 be, knew or should have known that the cause 

24 of action accrued. No cause of action barred 

25 under existing law on the effective date of the 
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•HR 328 IH 

1 Pharmaceutical Market Access Act of 2005 

2 shall be revived by such Act. 

3 ‘‘(H) MEASUREMENT OF DAMAGES.—In 

4 any action under this paragraph to enforce a 

5 cause of action under this subsection in which 

6 there has been a determination that a defend7 ant has violated a provision of this subsection, 

8 damages may be proved and assessed in the ag9 gregate by statistical or sampling methods, by 

10 the computation of illegal overcharges or by 

11 such other reasonable system of estimating ag12 gregate damages as the court in its discretion 

13 may permit without the necessity of separately 

14 proving the individual claim of, or amount of 

15 damage to, persons on whose behalf the suit 

16 was brought. 

17 ‘‘(I) EXCLUSION ON DUPLICATIVE RE18 LIEF.—The district court shall exclude from the 

19 amount of monetary relief awarded in an action 

20 under this paragraph brought by the attorney 

21 general of a State any amount of monetary re22 lief which duplicates amounts which have been 

23 awarded for the same injury. 

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

25 in this subsection shall be construed to modify, im-
35

•HR 328 IH 

1 pair, or supersede the operation of the antitrust 

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

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

4 section of the Clayton Act, except that it includes 

5 section 5 of the Federal Trade Commission Act to 

6 the extent that such section 5 applies to unfair 

7 methods of competition. 

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

9 term ‘manufacturer’ means any entity, including any 

10 affiliate or licensee of that entity, that is engaged 

11 in—

12 ‘‘(A) the production, preparation, propaga13 tion, compounding, conversion, or processing of 

14 a prescription drug, either directly or indirectly 

15 by extraction from substances of natural origin, 

16 or independently by means of chemical syn17 thesis, or by a combination of extraction and 

18 chemical synthesis; or 

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

20 relabeling, or distribution of a prescription 

21 drug.’’. 

22 (b) REGULATIONS.—The Federal Trade Commission 

23 shall promulgate regulations to carry out the enforcement 

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

25 and Cosmetic Act (as added by subsection (a)). 
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•HR 328 IH 

1 (c) SUSPENSION AND TERMINATION OF EXPORT2 ERS.—Section 804(g) of the Federal Food, Drug, and 

3 Cosmetic Act (as amended by section 4(g)) (21 U.S.C. 

4 384(g)) is amended by—

5 (1) striking ‘‘SUSPENSION OF IMPORTATION.—

6 The Secretary’’ and inserting 

7 ‘‘SUSPENSION OF IMPORTATION.—

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

9 (2) adding at the end the following: 

10 ‘‘(2) SUSPENSION AND TERMINATION OF EX11 PORTERS.—

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

13 effectiveness of a registration submitted under 

14 subsection (f) by a registered exporter: 

15 ‘‘(i) Subject to clause (ii), if the Sec16 retary determines, after notice and oppor17 tunity for a hearing, that the registered ex18 porter has failed to maintain substantial 

19 compliance with all registration conditions, 

20 the Secretary may suspend the registra21 tion. 

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

23 under color of the registration, the reg24 istered exporter has exported a drug that 

25 is not a qualifying drug, or a drug that 
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•HR 328 IH 

1 does not meet the criteria under this sec2 tion, or has exported a qualifying drug to 

3 an individual in violation of this section, 

4 the Secretary shall immediately suspend 

5 the registration. A suspension under the 

6 preceding sentence is not subject to the 

7 provision by the Secretary of prior notice, 

8 and the Secretary shall provide to the reg9 istered exporter involved an opportunity 

10 for a hearing not later than 10 days after 

11 the date on which the registration is sus12 pended. 

13 ‘‘(iii) The Secretary may reinstate the 

14 registration, whether suspended under 

15 clause (i) or (ii), if the Secretary deter16 mines that the registered exporter has 

17 demonstrated that further violations of 

18 registration conditions will not occur. 

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

20 notice and opportunity for a hearing, may ter21 minate the registration under subsection (f) of 

22 a registered exporter if the Secretary deter23 mines that the registered exporter has engaged 

24 in a pattern or practice of violating 1 or more 

25 registration conditions, or if on 1 or more occa-
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•HR 328 IH 

1 sions the Secretary has under subparagraph 

2 (A)(ii) suspended the registration of the reg3 istered exporter. The Secretary may make the 

4 termination permanent, or for a fixed period of 

5 not less than 1 year. During the period in 

6 which the registration of a registered exporter 

7 is terminated, any registration submitted under 

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

9 is a partner in the export enterprise or a prin10 cipal officer in such enterprise, and any reg11 istration prepared with the assistance of such 

12 exporter or such a person, has no legal effect 

13 under this section.’’. 

14 SEC. 10. AUTHORIZATION OF APPROPRIATIONS. 

15 There are authorized to be appropriated such sums 

16 as may be necessary to carry out this Act (and the amend17 ments made by this Act).

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