108TH CONGRESS

1ST SESSION H. R. 2427

AN ACT

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,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Pharmaceutical Mar3 ket Access Act of 2003’’.

4 SEC. 2. FINDINGS.

5 The Congress finds as follows:

6 (1) Americans unjustly pay up to 1000 percent

7 more to fill their prescriptions than consumers in

8 other countries.

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

10 market for pharmaceuticals yet consumers still pay

11 the world’s highest prices.

12 (3) An unaffordable drug is neither safe nor ef13 fective. Allowing and structuring the importation of

14 prescription drugs ensures access to affordable

15 drugs, thus providing a level of safety to American

16 consumers they do not currently enjoy.

17 (4) According to the Congressional Budget Of18 fice, American seniors alone will spend $1.8 trillion

19 dollars on pharmaceuticals over the next ten years.

20 (5) Allowing open pharmaceutical markets

21 could save American consumers at least $635 billion

22 of their own money each year.

23 SEC. 3. PURPOSES.

24 The purposes of this Act are as follows:

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 the

2 American pharmaceutical markets.

3 (3) To allow the importation of drugs only if

4 the drugs and the facilities where they are manufac5 tured are approved by the Food and Drug Adminis6 tration, and to exclude pharmaceutical narcotics.

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 (technologies similar to those used to

11 secure 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 180 days after the date

18 of the enactment of the Pharmaceutical Market

19 Access 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 amending paragraph (1) to read as

25 follows:
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1 ‘‘(1) require that each covered product imported

2 pursuant to such subsection complies with sections

3 501, 502, and 505, and other applicable require4 ments of 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 amending subparagraph (B) to

6 read as follows:

7 ‘‘(B) Certification from the importer or

8 manufacturer of such 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 amending subsection (e) to read as fol14 lows:

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 amending subparagraph (A) to read

15 as follows:

16 ‘‘(A) IN GENERAL.—The Secretary shall

17 conduct, or contract with an entity to conduct,

18 a study on the imports permitted pursuant to

19 subsection (a), including consideration of the

20 information received under subsection (d). In

21 conducting such study, the Secretary or entity

22 shall evaluate the compliance of importers with

23 regulations under subsection (a), and the inci24 dence of shipments pursuant to such sub25 section, if any, that have been determined to be
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1 misbranded or adulterated, and determine how

2 such compliance contrasts with the incidence of

3 shipments of prescription drugs transported

4 within the United States that have been deter5 mined to be misbranded or adulterated.’’; and

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

7 later than 2 years after the effective date of

8 final regulations under subsection (a),’’ and in9 serting ‘‘Not later than 18 months after the

10 date of the enactment of the Pharmaceutical

11 Market Access Act of 2003,’’;

12 (9) in subsection (k)(2)—

13 (A) by redesignating subparagraphs (D)

14 and (E) as subparagraphs (E) and (F), respec15 tively; and

16 (B) by inserting after subparagraph (C)

17 the following:

18 ‘‘(D) The term ‘qualifying individual’

19 means an individual who is not a pharmacist or

20 a wholesaler. ’’; and

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

22 SEC. 5. USE OF COUNTERFEIT-RESISTANT TECHNOLOGIES

23 TO PREVENT COUNTERFEITING.

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

25 Food, Drug, and Cosmetic Act (21 U.S.C. 352; deeming
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1 drugs and devices to be misbranded) is amended by adding

2 at the end the following:

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

4 the packaging of such drug complies with the require5 ments of section 505B for counterfeit-resistant tech6 nologies.’’.

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

8 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend9 ed by inserting after section 505A the following:

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

11 ‘‘(a) INCORPORATION OF COUNTERFEIT-RESISTANT

12 TECHNOLOGIES INTO PRESCRIPTION DRUG PACK13 AGING.—The Secretary shall require that the packaging

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

15 ‘‘(1) overt optically variable counterfeit-resist16 ant technologies that are described in subsection (b)

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

18 ‘‘(2) technologies that have an equivalent func19 tion of security, as determined by the Secretary.

20 ‘‘(b) ELIGIBLE TECHNOLOGIES.—Technologies de21 scribed in this subsection—

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

23 for visual identification of product authenticity with24 out the need for readers, microscopes, lighting de25 vices, or scanners;
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1 ‘‘(2) shall be similar to that used by the Bureau

2 of Engraving and Printing to secure United States

3 currency;

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

5 highly secure, tightly controlled environment; and

6 ‘‘(4) should incorporate additional layers of

7 non-visible covert security features up to and includ8 ing forensic capability.

9 ‘‘(c) STANDARDS FOR PACKAGING.—

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

11 of making it more difficult to counterfeit the pack12 aging of drugs subject to section 503(b), manufac13 turers of the drugs shall incorporate the technologies

14 described in subsection (b) into multiple elements of

15 the physical packaging of the drugs, including blister

16 packs, shrink wrap, package labels, package seals,

17 bottles, and boxes.

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

19 Shipments of drugs described in subsection (a) shall

20 include a label on the shipping container that incor21 porates the technologies described in subsection (b),

22 so that officials inspecting the packages will be able

23 to determine the authenticity of the shipment. Chain

24 of custody procedures shall apply to such labels and

25 shall include procedures applicable to contractual
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1 agreements for the use and distribution of the labels,

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

3 access for the relevant governmental agencies for

4 audit or verification of the use and distribution of

5 the labels.’’.

Passed the House of Representatives July 25 (legislative day, July 24), 2003.

Attest:

Clerk.
108TH CONGRESS

1ST SESSION H. R. 2427

AN ACT

To authorize the Secretary of Health and Human

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