II

106TH CONGRESS

1ST SESSION S. 1191

To amend the Federal Food, Drug, and Cosmetic Act to provide for facilitating the importation into the United States of certain drugs that

have been approved by the Food and Drug Administration, and for

other purposes.

IN THE SENATE OF THE UNITED STATES

JUNE 9, 1999

Mr. DORGAN (for himself, Mr. WELLSTONE, Ms. SNOWE, and Mr. JOHNSON)

introduced the following bill; which was read twice and referred to the

Committee on Health, Education, Labor, and Pensions

A BILL

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

provide for facilitating the importation into the United

States of certain drugs that have been approved by the

Food and Drug Administration, 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 ‘‘International Prescrip5 tion Drug Parity Act’’.
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1 SEC. 2. FACILITATION OF IMPORTATION OF DRUGS AP2 PROVED BY FOOD AND DRUG ADMINISTRA3 TION.

4 (a) IN GENERAL.—Section 801(d) of the Federal

5 Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is

6 amended—

7 (1) by redesignating paragraphs (3) and (4) as

8 paragraphs (4) and (5), respectively; and

9 (2) by striking ‘‘(d)(1)’’ and all that follows

10 through the end of paragraph (2) and inserting the

11 following:

12 ‘‘(d)(1) If a covered drug is domestically approved

13 and is manufactured in a State and exported, or such drug

14 is domestically approved and is for commercial distribu15 tion and is manufactured in a foreign establishment reg16 istered under section 510(i), the manufacturer shall, as

17 a condition of maintaining the domestic approval of the

18 drug, comply with the following:

19 ‘‘(A) Without regard to whether a shipment of

20 such drug is intended for importation into the

21 United States, for each shipment of such drug, the

22 manufacturer shall—

23 ‘‘(i) maintain a record that identifies the

24 shipment of such drug;

25 ‘‘(ii) maintain a record that details how

26 such shipment of such drug complies with cur-
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•S 1191 IS

1 rent good manufacturing practice and section

2 501; and

3 ‘‘(iii) provide the labeling required for any

4 such drug pursuant to section 502 and pursu5 ant to the application for domestic approval.

6 ‘‘(B) Upon the request of a person who intends

7 to import into the United States drugs from such

8 shipment (and who meets applicable legal require9 ments to be an importer of covered drugs), the man10 ufacturer shall provide to the person a copy of each

11 of the records maintained under subparagraph (A)

12 with respect to the shipment.

13 ‘‘(2) For the purpose of facilitating the importation

14 into the United States of covered drugs, the Secretary

15 shall promulgate by regulation the following:

16 ‘‘(A) Criteria regarding the records described in

17 paragraph (1) and use of the records to demonstrate

18 domestic approval of the drugs and compliance with

19 sections 501 and 502.

20 ‘‘(B) Criteria regarding labeling requirements

21 for the drugs that the Secretary determines to be

22 appropriate.

23 ‘‘(C) Criteria regarding the amount of charges

24 that may be imposed by manufacturers of the drugs
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1 for maintaining and providing the records specified

2 in subparagraph (A).

3 ‘‘(3) In this subsection:

4 ‘‘(A) The term ‘covered drug’ means a drug

5 that is described in section 503(b)(1) or is composed

6 wholly or partly of insulin.

7 ‘‘(B) The term ‘domestically approved’, with re8 spect to a drug, means a drug for which an applica9 tion is approved under section 505, or as applicable,

10 under section 351 of the Public Health Service Act

11 (42 U.S.C. 262). The term ‘domestic approval’, with

12 respect to a drug, means approval of an application

13 for a drug under such a section.’’.

14 (b) CONFORMING AMENDMENTS.—

15 (1) Section 801(d) of the Federal Food, Drug,

16 and Cosmetic Act (21 U.S.C. 381(d)) is amended in

17 paragraph (5) (as redesignated by subsection (a)(1))

18 by striking ‘‘paragraph (3)’’ each place such term

19 appears and inserting ‘‘paragraph (4)’’.

20 (2) Section 301(w) of the Federal Food, Drug,

21 and Cosmetic Act (21 U.S.C. 331(w)) is amended—

22 (A) by striking ‘‘801(d)(3)’’ each place it

23 appears and inserting ‘‘801(d)(4)’’;

24 (B) by striking ‘‘801(d)(3)(A)’’ and insert25 ing ‘‘801(d)(4)(A)’’; and
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1 (C) by striking ‘‘801(d)(3)(B)’’ and insert2 ing ‘‘801(d)(4)(B)’’.

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