II 

Calendar No. 436

108TH CONGRESS 

2D SESSION S. 2137

To authorize the Secretary of Health and Human Services to promulgate 

regulations for the reimportation of prescription drugs, and for other 

purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 26, 2004

Mr. DORGAN (for himself, Ms. SNOWE, Ms. STABENOW, Mr. MCCAIN, and Mr. 

DASCHLE) introduced the following bill; which was read the first time 

FEBRUARY 27, 2004

Read the second time and placed on the calendar 

A BILL

To authorize the Secretary of Health and Human Services 

to promulgate regulations for the reimportation 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 2003’’. 
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1 SEC. 2. FINDINGS. 

2 Congress finds that—

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 largest market for 

7 pharmaceuticals in the world, yet American con8 sumers pay the highest prices for pharmaceuticals in 

9 the world; 

10 (3) an unaffordable drug is neither safe nor ef11 fective; 

12 (4) allowing and structuring the importation of 

13 prescription drugs ensures access to affordable 

14 drugs, thus providing a level of safety to American 

15 consumers that consumers do not currently enjoy; 

16 (5) according to the Congressional Budget Of17 fice, American seniors alone will spend 

18 $1,800,000,000,000 on pharmaceuticals over the 

19 next 10 years; and 

20 (6) allowing open pharmaceutical markets could 

21 save American consumers at least $635,000,000,000 

22 each year. 

23 SEC. 3. PURPOSES. 

24 The purposes of this Act are—

25 (1) to give all Americans immediate relief from 

26 the outrageously high cost of pharmaceuticals; 
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1 (2) to reverse the perverse economics of Amer2 ican pharmaceutical markets; 

3 (3) to allow the importation of drugs (excluding 

4 pharmaceutical narcotics) only if the drugs and the 

5 facilities in which the drugs are manufactured are 

6 approved by the Food and Drug Administration; and 

7 (4) to require that imported prescription drugs 

8 be packaged and shipped using counterfeit-resistant 

9 technologies approved by the Bureau of Engraving 

10 and Printing, similar to the technologies used to se11 cure United States currency. 

12 SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS. 

13 Section 804 of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 384) is amended—

15 (1) in subsection (a)—

16 (A) by striking ‘‘The Secretary’’ and in17 serting ‘‘Not later than 181 days after the date 

18 of enactment of the Pharmaceutical Market Ac19 cess Act of 2003, the Secretary’’; and 

20 (B) by striking ‘‘pharmacists and whole21 salers’’ and inserting ‘‘pharmacists, wholesalers, 

22 and qualifying individuals’’; 

23 (2) in subsection (b)—

24 (A) by striking paragraph (1) and insert25 ing the following: 
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1 ‘‘(1) require that each covered product imported 

2 under that subsection complies with sections 501, 

3 502, and 505 and other applicable requirements of 

4 this Act; and’’; 

5 (B) in paragraph (2), by striking ‘‘, includ6 ing subsection (d); and’’ and inserting a period; 

7 and 

8 (C) by striking paragraph (3); 

9 (3) in subsection (c), by inserting ‘‘by phar10 macists and wholesalers (but not qualifying individ11 uals)’’ after ‘‘importation of covered products’’; 

12 (4) in subsection (d)—

13 (A) by striking paragraphs (3) and (10); 

14 (B) in paragraph (5), by striking ‘‘, includ15 ing the professional license number of the im16 porter, if any’’; 

17 (C) in paragraph (6)—

18 (i) in subparagraph (C), by inserting 

19 ‘‘(if required under subsection (e))’’ before 

20 the period; 

21 (ii) in subparagraph (D), by inserting 

22 ‘‘(if required under subsection (e))’’ before 

23 the period; and 

24 (iii) in subparagraph (E), by striking 

25 ‘‘labeling’’; 
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1 (D) in paragraph (7)—

2 (i) in subparagraph (A), by inserting 

3 ‘‘(if required under subsection (e))’’ before 

4 the period; and 

5 (ii) by striking subparagraph (B) and 

6 inserting the following: 

7 ‘‘(B) Certification from the importer or 

8 manufacturer of the product that the product 

9 meets all requirements of this Act.’’; and 

10 (E) by redesignating paragraphs (4) 

11 through (9) as paragraphs (3) through (8), re12 spectively; 

13 (5) by striking subsection (e) and inserting the 

14 following: 

15 ‘‘(e) TESTING.—

16 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

17 regulations under subsection (a) shall require that 

18 testing referred to in paragraphs (5) through (7) of 

19 subsection (d) be conducted by the importer of the 

20 covered product, unless the covered product is a pre21 scription drug subject to the requirements of section 

22 505B for counterfeit-resistant technologies. 

23 ‘‘(2) EXCEPTION.—The testing requirements of 

24 paragraphs (5) through (7) of subsection (d) shall 
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1 not apply to an importer unless the importer is a 

2 wholesaler.’’; 

3 (6) in subsection (f), by striking ‘‘or designated 

4 by the Secretary, subject to such limitations as the

5 Secretary determines to be appropriate to protect 

6 the public health’’; 

7 (7) in subsection (g)—

8 (A) by striking ‘‘counterfeit or’’; and 

9 (B) by striking ‘‘and the Secretary deter10 mines that the public is adequately protected 

11 from counterfeit and violative covered products 

12 being imported pursuant to subsection (a)’’; 

13 (8) in subsection (i)(1)—

14 (A) by striking subparagraph (A) and in15 serting the following: 

16 ‘‘(A) STUDY.—

17 ‘‘(i) IN GENERAL.—The Secretary 

18 shall conduct, or contract with an entity to 

19 conduct, a study on the imports permitted 

20 under subsection (a), including consider21 ation of the information received under 

22 subsection (d). 

23 ‘‘(ii) EVALUATION.— In conducting 

24 the study, the Secretary or entity shall—
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1 ‘‘(I) evaluate the compliance of 

2 importers with regulations under sub3 section (a), and the incidence of ship4 ments under that subsection, if any, 

5 that have been determined to be mis6 branded or adulterated; and 

7 ‘‘(II) determine how that compli8 ance contrasts with the incidence of 

9 shipments of prescription drugs trans10 ported within the United States that 

11 have been determined to be mis12 branded or adulterated.’’; and 

13 (B) in subparagraph (B), by striking ‘‘Not 

14 later than 2 years after the effective date of 

15 final regulations under subsection (a),’’ and in16 serting ‘‘Not later than 18 months after the 

17 date of enactment of the Pharmaceutical Mar18 ket Access Act of 2003,’’; 

19 (9) in subsection (k)(2)—

20 (A) by redesignating subparagraphs (D) 

21 and (E) as subparagraphs (E) and (F), respec22 tively; and 

23 (B) by inserting after subparagraph (C) 

24 the following: 
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1 ‘‘(D) QUALIFYING INDIVIDUAL.—The term 

2 ‘qualifying individual’ means an individual who 

3 is not a pharmacist or a wholesaler. ’’; and 

4 (10) by striking subsections (l) and (m). 

5 SEC. 5. USE OF COUNTERFEIT-RESISTANT TECHNOLOGIES 

6 TO PREVENT COUNTERFEITING. 

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

8 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend9 ed by adding at the end the following: 

10 ‘‘(w) If it is a drug subject to section 503(b), unless 

11 the packaging of the drug complies with the requirements 

12 of section 505B for counterfeit-resistant technologies.’’. 

13 (b) REQUIREMENTS.—Title V of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend15 ed by inserting after section 505A the following: 

16 ‘‘SEC. 505B. COUNTERFEIT-RESISTANT TECHNOLOGIES. 

17 ‘‘(a) INCORPORATION OF COUNTERFEIT-RESISTANT

18 TECHNOLOGIES INTO PRESCRIPTION DRUG PACK19 AGING.—The Secretary shall require that the packaging 

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

21 ‘‘(1) overt optically variable counterfeit-resist22 ant technologies that are described in subsection (b) 

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

24 ‘‘(2) technologies that have an equivalent func25 tion of security, as determined by the Secretary. 
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1 ‘‘(b) ELIGIBLE TECHNOLOGIES.—Technologies de2 scribed in this subsection—

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

4 for visual identification of product authenticity with5 out the need for readers, microscopes, lighting de6 vices, or scanners; 

7 ‘‘(2) shall be similar to the technologies used by 

8 the Bureau of Engraving and Printing to secure 

9 United States currency; 

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

11 highly secure, tightly controlled environment; and 

12 ‘‘(4) should incorporate additional layers of 

13 nonvisible covert security features up to and includ14 ing forensic capability. 

15 ‘‘(c) STANDARDS FOR PACKAGING.—

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

17 of making it more difficult to counterfeit the pack18 aging of drugs subject to section 503(b), a manufac19 turer of the drugs shall incorporate the technologies 

20 described in subsection (b) into multiple elements of 

21 the physical packaging of the drugs, including blister 

22 packs, shrink wrap, package labels, package seals, 

23 bottles, and boxes. 

24 ‘‘(2) LABELING OF SHIPPING CONTAINER.—
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1 ‘‘(A) IN GENERAL.—A shipment of a drug 

2 described in subsection (a) shall include a label 

3 on the shipping container that incorporates the 

4 technologies described in subsection (b), so that 

5 officials inspecting the packages will be able to 

6 determine the authenticity of the shipment. 

7 ‘‘(B) CHAIN-OF-CUSTODY PROCEDURES.—

8 ‘‘(i) IN GENERAL.—A manufacturer of 

9 a drug described in subsection (a) shall en10 sure that chain-of-custody procedures 

11 apply to a label required under subpara12 graph (A). 

13 ‘‘(ii) REQUIRED PROCEDURES.—

14 Chain-of-custody procedures required 

15 under clause (i) shall include—

16 ‘‘(I) procedures applicable to con17 tractual agreements for the use and 

18 distribution of the labels; 

19 ‘‘(II) methods to audit the use of 

20 the labels; and 

21 ‘‘(III) database access for the rel22 evant governmental agencies for audit 

23 or verification of the use and distribu24 tion of the labels.’’.

Calendar No. 436

108TH CONGRESS 

2D SESSION S. 2137

A BILL

To authorize the Secretary of Health and Human 

Services to promulgate regulations for the reimportation of prescription drugs, and for other purposes. 

FEBRUARY 27, 2004

Read the second time and placed on the calendar