IV

106TH CONGRESS

2D SESSION H. CON. RES. 420

Providing for corrections in the enrollment of the bill H.R. 4461.

IN THE HOUSE OF REPRESENTATIVES

OCTOBER 10, 2000

Ms. KAPTUR (for herself and Mr. Obey) submitted the following concurrent

resolution; which was referred to the Committee on Commerce, and in addition to the Committee on House Administration, 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

CONCURRENT RESOLUTION

Providing for corrections in the enrollment of the bill H.R.

4461.

1 Resolved by the House of Representatives (the Senate

2 concurring), That, in the enrollment of the bill (H.R.

3 4461) making appropriations for Agriculture, Rural De4 velopment, Food and Drug Administration, and Related

5 Agencies programs for the fiscal year ending September

6 30, 2001, and for other purposes, the Clerk of the House

7 shall strike section 745 and insert the following:
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1 SEC. 745. (a) SHORT TITLE.—This section may be

2 cited as the ‘‘Medicine Equity and Drug Safety Act of

3 2000’’.

4 (b) FINDINGS.—Congress makes the following find5 ings:

6 (1) The cost of prescription drugs for Ameri7 cans continues to rise at an alarming rate.

8 (2) Millions of Americans, including medicare

9 beneficiaries on fixed incomes, face a daily choice be10 tween purchasing life-sustaining prescription drugs,

11 or paying for other necessities, such as food and

12 housing.

13 (3) Many life-saving prescription drugs are

14 available in countries other than the United States

15 at substantially lower prices, even though such drugs

16 were developed and are approved for use by patients

17 in the United States.

18 (4) Many Americans travel to other countries to

19 purchase prescription drugs because the medicines

20 that they need are unaffordable in the United

21 States.

22 (5) Americans should be able to purchase medi23 cines at prices that are comparable to prices for

24 such medicines in other countries, but efforts to en25 able such purchases should not endanger the gold
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1 standard for safety and effectiveness that has been

2 established and maintained in the United States.

3 (c) IMPORTS AND EXPORTS.—Chapter VIII of the

4 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381

5 et seq.) is amended—

6 (1) in section 801(d)(1), by inserting ‘‘and sec7 tion 804’’ after ‘‘paragraph (2)’’; and

8 (2) by adding at the end the following:

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

10 ‘‘(a) REGULATIONS.—

11 ‘‘(1) IN GENERAL.—The Secretary, after con12 sultation with the United States Trade Representa13 tive and the Commissioner of Customs, shall promul14 gate regulations permitting a pharmacist or whole15 saler to import into the United States covered prod16 ucts. Such regulations shall be promulgated as expe17 ditiously as possible, but in no case later than two

18 years after the date of the enactment of the Medi19 cine Equity and Drug Safety Act of 2000.

20 ‘‘(2) LIMITATION.—Regulations promulgated

21 under paragraph (1) shall—

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

23 that provide a reasonable assurance to the Sec24 retary that each covered product that is im25 ported is safe and effective for its intended use;
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1 ‘‘(B) require that the pharmacist or whole2 saler importing a covered product complies with

3 the provisions of paragraph (3); and

4 ‘‘(C) contain such additional safeguards as

5 the Secretary may specify in order to ensure

6 the protection of the public health of patients in

7 the United States or to facilitate the importa8 tion of covered products.

9 ‘‘(3) INFORMATION AND RECORDS.—Regula10 tions promulgated under paragraph (1) shall require

11 such pharmacist or wholesaler to provide informa12 tion and records to the Secretary, including—

13 ‘‘(A) the name and amount of the active

14 ingredient of the product and description of the

15 dosage form;

16 ‘‘(B) the date that such product is shipped

17 and the quantity of such product that is

18 shipped, the point of origin and the United

19 States consignee of such product, and the price

20 paid for such product;

21 ‘‘(C) documentation from the foreign seller

22 specifying the original source of the product

23 and the amount of each lot of the product origi24 nally received;
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1 ‘‘(D) the manufacturer’s lot or control

2 number of the product imported;

3 ‘‘(E) the name, address, and telephone

4 number of the importer and consignee, includ5 ing the professional license number of the im6 porter, if the importer is a pharmacist or phar7 maceutical wholesaler;

8 ‘‘(F) for a product that is—

9 ‘‘(i) coming from the first foreign re10 cipient of the product who received such

11 product from the manufacturer—

12 ‘‘(I) documentation dem13 onstrating that such product came

14 from such recipient and was received

15 by such recipient from such manufac16 turer;

17 ‘‘(II) documentation of the

18 amount of each lot of the product re19 ceived by such recipient to dem20 onstrate that the amount being im21 ported into the United States is not

22 more than the amount that was re23 ceived by such recipient;

24 ‘‘(III) documentation dem25 onstrating that a statistically valid
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1 sample of each lot of the initial im2 ported shipment was tested at an ap3 propriate Food and Drug Administra4 tion approved United States labora5 tory for authenticity and degradation

6 by the importer or manufacturer of

7 such product;

8 ‘‘(IV) documentation dem9 onstrating that a statistically valid

10 sample of all subsequent shipments

11 from such recipient was tested at an

12 appropriate Food and Drug Adminis13 tration approved United States lab14 oratory for authenticity and degrada15 tion by the importer or manufacturer

16 of such product; and

17 ‘‘(V) certification from the im18 porter or manufacturer of such prod19 uct that the product is approved for

20 marketing in the United States and

21 meets all labeling requirements under

22 this Act; and

23 ‘‘(ii) not coming from the first foreign

24 recipient of the product, documentation

25 demonstrating that a statistically valid
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1 sample of each lot was tested for authen2 ticity and degradation at an appropriate

3 Food and Drug Administration approved

4 United States laboratory by the importer

5 or manufacturer of such product, and

6 meets all labeling requirements under this

7 Act;

8 ‘‘(G) complete data derived from all tests

9 necessary to assure that the product is in com10 pliance with established specifications and

11 standards, including laboratory records; and

12 ‘‘(H) any other information that the Sec13 retary determines is necessary to ensure the

14 protection of the public health of patients in the

15 United States.

16 ‘‘(4) RECORDS MAINTAINED BY SECRETARY.—

17 Records described in paragraph (3) shall be main18 tained by the Secretary for a period of time deter19 mined to be necessary by the Secretary.

20 ‘‘(5) RECORDS MAINTAINED BY IMPORTER.—

21 The pharmacist or wholesaler who imports a covered

22 product as described in paragraph (1) shall maintain

23 records documenting the resale price for such prod24 uct for a period of time specified by the Secretary.
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1 Such records shall be provided upon request to fa2 cilitate the studies under this section.

3 ‘‘(b) TESTING.—

4 ‘‘(1) IN GENERAL.—Testing referred to in sub5 paragraphs (F) and (G) of subsection (a)(3) may be

6 conducted by the pharmacist or wholesaler who is

7 importing such product, or by the manufacturer of

8 the product, in a Food and Drug Administration ap9 proved laboratory. Such testing may also be con10 ducted by an independent laboratory under contract

11 with such pharmacist, wholesaler, or manufacturer.

12 ‘‘(2) AUTHENTICATION.—

13 ‘‘(A) IN GENERAL.—In conducting tests

14 under paragraph (1), the manufacturer of such

15 product shall provide to the pharmacist or

16 wholesaler, information—

17 ‘‘(i) to authenticate such product and

18 confirm that the labeling of such product

19 complies with labeling requirements under

20 this Act; and

21 ‘‘(ii) to indicate if such product is eli22 gible for importation under this section.

23 ‘‘(B) CONFIDENTIALITY.—Information

24 supplied under subparagraph (A) and sub25 section (a)(3)(A) shall not be disclosed for any
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1 purpose not authorized by this section. Any per2 son who knowingly and willingly discloses such

3 information for purposes not authorized by this

4 section shall be imprisoned for a period not to

5 exceed 18 months, fined in accordance with title

6 18, United States Code, or both.

7 ‘‘(3) DISCRETION.—The Secretary may waive

8 or modify testing requirements described under sub9 section (a)(3) if agreements have been entered into

10 by the Secretary that ensure the safety and effec11 tiveness of the product imported from a specific

12 country, or through a specific distribution chain cer13 tified by the Secretary.

14 ‘‘(c) APPROVED LABELING.—The manufacturer of a

15 covered product shall provide to the importer involved

16 written authorization for the importer to use at no cost

17 the approved labeling for such product.

18 ‘‘(d) NON-DISCRIMINATION.—No manufacturer of a

19 covered product may take actions that discriminate

20 against, or cause other persons to discriminate against,

21 United States pharmacists or wholesalers regarding the

22 sale or distribution of covered products.

23 ‘‘(e) STUDY AND REPORT.—

24 ‘‘(1) STUDY.—The General Accounting Office

25 shall conduct a study on the imports permitted
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1 under this section, taking into consideration the in2 formation received under subsection (a). In con3 ducting such study, the Office shall—

4 ‘‘(A) evaluate importer’s compliance with

5 regulations, determine the number of ship6 ments, if any, permitted under this section that

7 have been determined to be counterfeit, mis8 branded, or adulterated; and

9 ‘‘(B) consult with the United States Trade

10 Representative and United States Patent and

11 Trademark Office to evaluate the effect of im12 portations permitted under this Act on trade

13 and patent rights under Federal law.

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

15 effective date of final regulations issued pursuant to

16 this section, the General Accounting Office shall pre17 pare and submit to Congress a report containing the

18 study described in paragraph (1).

19 ‘‘(f) CONSTRUCTION.—Nothing in this section shall

20 be construed to limit the statutory, regulatory, or enforce21 ment authority of the Secretary relating to importation

22 of covered products, other than the importation described

23 in subsection (a).

24 ‘‘(g) DEFINITIONS.—In this section:

25 ‘‘(1) COVERED PRODUCT.—
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1 ‘‘(A) IN GENERAL.—The term ‘covered

2 product’ means a prescription drug product

3 under section 503(b)(1) that meets the applica4 ble requirements of section 505, and is ap5 proved by the Food and Drug Administration

6 and manufactured in a facility identified in the

7 approved application and is not adulterated

8 under section 501 or misbranded under section

9 502.

10 ‘‘(B) CHARITABLE CONTRIBUTIONS; PAR11 ENTERAL DRUGS.—Notwithstanding any other

12 provision of this section, section 801(d)(1)—

13 ‘‘(i) continues to apply to a covered

14 product donated at no cost by the manu15 facturer of the drug to a charitable or hu16 manitarian organization, including the

17 United Nations and affiliates, or to a gov18 ernment of a foreign country; and

19 ‘‘(ii) continues to apply to a covered

20 product that is a parenteral drug the im21 portation of which pursuant to subsection

22 (a) is determined by the Secretary to pose

23 a threat to the public health.

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

25 means a person licensed to practice pharmacy under
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1 State law, including the dispensing and selling of

2 prescription drugs, or an entity licensed or otherwise

3 authorized as a pharmacy under State law.

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

5 means a person licensed as a wholesaler or dis6 tributor of prescription drug products in the United

7 States pursuant to section 503(e)(2)(A).

8 ‘‘(4) DISCRIMINATION.—The term ‘discrimina9 tion’ includes with respect to United States phar10 macists or wholesalers a contract provision, a limita11 tion on supply, or other measure which has the ef12 fect of providing U.S. pharmacists or wholesalers ac13 cess to covered products on terms or conditions that

14 are less favorable than the terms or conditions pro15 vided to any foreign purchaser (other than a chari16 table purchaser) of such products, or otherwise has

17 the effect of restricting the access of United States

18 pharmacists or wholesalers to prescription drugs

19 that can be imported into the United States under

20 this section.

21 ‘‘(h) FUNDING.—For the purpose of carrying out this

22 section—

23 ‘‘(1) there is hereby appropriated, out of any

24 money in the Treasury not otherwise appropriated,

25 $23,000,000 for fiscal year 2001; and
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1 ‘‘(2) there are authorized to be appropriated for

2 fiscal year 2002 and each subsequent fiscal year

3 such sums as may be necessary.

4 ‘‘(i) CONDITIONS.—Regulations promulgated under

5 subsection (a)(1) shall become effective only if the Sec6 retary certifies to the Congress that the implementation

7 of this section will pose no greater risk to the public’s

8 health and safety than would otherwise apply.’’.

9 (d) PROHIBITED ACT.—

10 (1) IN GENERAL.—Section 301 of the Federal

11 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is

12 amended by adding at the end the following:

13 ‘‘(aa) The importation of a covered product in viola14 tion of section 804, the falsification of any record required

15 to be maintained or provided to the Secretary under such

16 section, or any other violation of requirements under such

17 section.’’.

18 (2) ENHANCED PENALTIES.—Section 303(b) of

19 the Federal Food, Drug, and Cosmetic Act (21

20 U.S.C. 333(b)) is amended by adding at the end the

21 following:

22 ‘‘(6) Notwithstanding subsection (a), any person who

23 is a manufacturer or importer of a covered product pursu24 ant to section 804(a) and knowingly fails to comply with

25 a requirement of subsection (b), (c), or (d) of section 804
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1 that is applicable to such manufacturer or importer, re2 spectively, shall be imprisoned for not more than 10 years

3 or fined not more than $1,000,000, or both.’’.

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