II

106TH CONGRESS

2D SESSION S. 2520

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

importation of certain covered products, and for other purposes.

IN THE SENATE OF THE UNITED STATES

MAY 9, 2000

Mr. JEFFORDS (for himself, Mr. WELLSTONE, Ms. SNOWE, and Ms. COLLINS)

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

allow for the importation of certain covered products,

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 ‘‘Medicine Equity and

5 Drug Safety Act of 2000’’.

6 SEC. 2. FINDINGS.

7 Congress makes the following findings:

8 (1) The cost of prescription drugs for Ameri9 cans continues to rise at an alarming rate.
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1 (2) Millions of Americans, including medicare

2 beneficiaries on fixed incomes, face a daily choice be3 tween purchasing life-sustaining prescription drugs,

4 or paying for other necessities, such as food and

5 housing.

6 (3) Many life-saving prescription drugs are

7 available in countries other than the United States

8 at substantially lower prices, even though such drugs

9 were developed and are approved for use by patients

10 in the United States.

11 (4) Many Americans travel to Canada or other

12 countries to purchase prescription drugs because the

13 medicines that they need are unaffordable in the

14 United States.

15 (5) Americans should be able to purchase medi16 cines at prices that are comparable to prices for

17 such medicines in other countries, but efforts to en18 able such purchases should not endanger the gold

19 standard for safety and effectiveness that has been

20 established and maintained in the United States.

21 SEC. 3. IMPORTATION OF COVERED PRODUCTS.

22 Chapter VIII of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 381 et seq.) is amended—

24 (1) in section 801(d)(1), by inserting ‘‘and sec25 tion 804’’ after ‘‘paragraph (2)’’; and
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1 (2) by adding at the end the following:

2 ‘‘SEC. 804. IMPORTATION OF COVERED PRODUCTS.

3 ‘‘(a) REGULATIONS.—

4 ‘‘(1) IN GENERAL.—Notwithstanding sections

5 301(d), 301(t), and 801(a), the Secretary, after con6 sultation with the United States Trade Representa7 tive and the Commissioner of Customs, shall promul8 gate regulations permitting importation into the

9 United States of covered products.

10 ‘‘(2) LIMITATION.—Regulations promulgated

11 under paragraph (1) shall—

12 ‘‘(A) require that safeguards are in place

13 that provide a reasonable assurance to the Sec14 retary that each covered product that is im15 ported is safe and effective for its intended use;

16 ‘‘(B) require that the individual, or phar17 macist or wholesaler, importing a covered prod18 uct complies with the provisions of subsection

19 (b) or (c), as appropriate; and

20 ‘‘(C) contain such additional safeguards as

21 the Secretary may specify in order to ensure

22 the safety of patients in the United States.

23 ‘‘(3) SAFEGUARDS.—In determining safeguards

24 for a covered product under paragraph (2)(C), the

25 Secretary shall consider the adequacy of the regu-
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1 latory structure of the exporting country to ensure

2 the safety and effectiveness of the covered product.

3 ‘‘(4) RECORDS.—Regulations promulgated

4 under paragraph (1) shall require that records re5 garding importation described in subsections (b) and

6 (c) be gathered and maintained by the Secretary for

7 a period of time determined to be necessary by the

8 Secretary.

9 ‘‘(b) PERSONAL BAGGAGE.—

10 ‘‘(1) IN GENERAL.—The Secretary shall pro11 mulgate regulations that permit an individual to im12 port into the United States a covered product in per13 sonal baggage.

14 ‘‘(2) REGULATIONS.—Regulations promulgated

15 under paragraph (1) shall require an individual im16 porting a covered product to—

17 ‘‘(A) affirm in writing that the product is

18 for personal use of the individual;

19 ‘‘(B) seek to import an amount of the

20 product appropriate for personal use, such as a

21 3-month supply; and

22 ‘‘(C) provide to the Secretary—

23 ‘‘(i) the name and address of a health

24 professional licensed to prescribe drugs in

25 the United States that is responsible for
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1 treatment with the product, or evidence

2 that the product is for the continuation of

3 a treatment begun in a foreign country;

4 ‘‘(ii) a description of the product, in5 cluding the name, the amount being im6 ported, and the price paid for the product;

7 ‘‘(iii) information indicating the des8 tination of the product;

9 ‘‘(iv) information indicating the date

10 on which and the place where the product

11 was purchased;

12 ‘‘(v) the name, address, and telephone

13 number of the importer; and

14 ‘‘(vi) any other information that the

15 Secretary determines is necessary to en16 sure that the product being imported is

17 safe and effective for its intended use, and

18 to ensure that the Secretary maintains the

19 ability to track an imported product that is

20 found to be counterfeit, expired, subpotent,

21 or otherwise unsafe or ineffective for its in22 tended use.

23 ‘‘(c) REIMPORTATION.—

24 ‘‘(1) IN GENERAL.—The Secretary shall pro25 mulgate regulations that permit a pharmacist or
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1 wholesaler to import into the United States a cov2 ered product that meets the requirements of sections

3 501, 502, and 505, and was manufactured in a

4 State and exported, or in an establishment reg5 istered under 510.

6 ‘‘(2) REGULATIONS.—Regulations promulgated

7 under paragraph (1) shall require a pharmacist or

8 wholesaler to provide to the Secretary—

9 ‘‘(A) a description of the product, includ10 ing the name, the amount being imported, and

11 the price paid for the product;

12 ‘‘(B) information indicating the destination

13 of the product;

14 ‘‘(C) information indicating the date on

15 which and the place where the product was pur16 chased;

17 ‘‘(D) the name, address, and telephone

18 number of the importer, and the professional li19 cense number of the pharmacist or wholesaler;

20 ‘‘(E) information demonstrating to the sat21 isfaction of the Secretary that the product

22 being imported was manufactured in a State or

23 at an establishment registered under section

24 510; and
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1 ‘‘(F) any other information that the Sec2 retary determines is necessary to ensure that

3 the product being imported is safe and effective.

4 ‘‘(d) STUDY AND REPORT.—

5 ‘‘(1) STUDY.—The Secretary shall conduct, or

6 contract with an entity to conduct, a study on the

7 imports permitted under this section, taking into

8 consideration the information received under sub9 sections (a), (b), and (c). In conducting such study,

10 the Secretary or entity shall evaluate the safety and

11 purity of the products imported, and other patent

12 and trade issues that may have an effect on the

13 safety or availability of such products .

14 ‘‘(2) REPORT.—Not later than 5 years after the

15 date of enactment of this section, the Secretary shall

16 prepare and submit to Congress a report containing

17 the study described in paragraph (1).

18 ‘‘(e) CONSTRUCTION.—Nothing in this section shall

19 be construed to limit the statutory, regulatory, or enforce20 ment authority of the Secretary relating to importation

21 of covered products, other than the importation described

22 in subsections (a), (b), and (c).

23 ‘‘(f) LIMITATION.—Information collected pursuant to

24 this section shall be subject to the provisions of section
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1 522a of title 5, United States Code (commonly known as

2 the ‘Privacy Act of 1974’).

3 ‘‘(g) DEFINITIONS.—In this section:

4 ‘‘(1) COVERED PRODUCT.—The term ‘covered

5 product’ means a prescription drug under section

6 503(b)(1).

7 ‘‘(2) PHARMACIST.—The term ‘pharmacist’

8 means a person licensed by a State to practice phar9 macy in the United States, including the dispensing

10 and selling of prescription drugs.

11 ‘‘(3) WHOLESALER.—The term ‘wholesaler’

12 means a person licensed as a wholesaler or dis13 tributor of prescription drugs in the United States.’’.

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