II

103D CONGRESS

2D SESSION S. 2168

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

distribution of samples of prescription drugs.

IN THE SENATE OF THE UNITED STATES

JUNE 8 (legislative day, JUNE 7), 1994

Mrs. KASSEBAUM introduced the following bill; which was read twice and

referred to the Committee on Labor and Human Resources

A BILL

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

prohibit the distribution of samples of prescription drugs.

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 AND REFERENCE.

4 (A) SHORT TITLE.—This Act may be cited as the

5 ‘‘Prescription Drug Marketing Reform Act of 1994’’.

6 (b) REFERENCE.—Whenever in this Act an amend7 ment or repeal is expressed in terms of an amendment

8 to, or repeal of, a section or other provision, the reference

9 shall be considered to be made to a section or other provi10 sion of the Federal Food, Drug, and Cosmetic Act.
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1 SEC. 2. PROHIBITION OF DRUG SAMPLES.

2 Section 503 (21 U.S.C. 353) is amended—

3 (1) in the first sentence of subsection (c)(1), by

4 inserting ‘‘distribute,’’ after ‘‘No person may’’,

5 (2) in the second sentence of such subsection,

6 by striking ‘‘and subsection (d)’’,

7 (3) by inserting after the second sentence of

8 such subsection the following: ‘‘For purposes of this

9 subsection, the term ‘distribute’ does not include

10 providing a drug sample to enable a practitioner li11 censed to prescribe a drug subject to subsection (b)

12 or a health care professional acting under the direc13 tion and supervision of such a practitioner to provide

14 for the dispensing of or to dispense a sample of such

15 drug if the sample is made available to a patient in

16 accordance with regulations of the Secretary specify17 ing conditions under which such drug is necessary

18 for medical care.’’,

19 (4) in paragraph (2), by inserting ‘‘distribute,’’

20 after ‘‘No person may’’,

21 (5) by redesignating paragraph (3) as para22 graph (4) and by adding after paragraph (2) the

23 following:

24 ‘‘(3) Nothing in paragraphs (1) and (2) precludes dis25 tribution of a drug subject to subsection (b) at no cost

26 or nominal cost pursuant to a program established by the
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•S 2168 IS

1 manufacturer or distributor of such drug to provide it to

2 specific identified patients who, for financial reasons,

3 would not otherwise have access to such drug. The Sec4 retary shall promulgate regulations to specify the docu5 mentation and record keeping required for such a pro6 gram.’’, and

7 (6) by repealing subsection (d) and redesignat8 ing subsections (e), (f), and (g) as subsections (d),

9 (e), and (f), respectively.

10 SEC. 3. ENFORCEMENT.

11 (a) PROHIBITED ACT.—Section 301(t) (21 U.S.C.

12 331(t)) is amended to read as follows:

13 ‘‘(t) the importation of a drug in violation of section

14 801(d)(1), the distribution, sale, purchase, or trade of a

15 drug or drug sample or the offer to distribute, sell, pur16 chase, or trade a drug or drug sample in violation of sec17 tion 503(c), the distribution, sale, purchase, or trade of

18 a coupon or the offer to distribute, sell, purchase, or trade

19 such a coupon in violation of section 503(c)(2), or the dis20 tribution of drugs in violation of section 503(d) or the fail21 ure to otherwise comply with the requirements of section

22 503(d).’’.

23 (b) PENALTY.—Section 303(b) (21 U.S.C. 333(b)) is

24 amended—
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1 (1) in subparagraph (B), by inserting ‘‘distrib2 ute,’’ after ‘‘knowingly’’,

3 (2) in subparagraph (C), by inserting ‘‘distrib4 uting,’’ after ‘‘knowingly’’,

5 (3) in subparagraph (D), by striking

6 ‘‘503(e)(2)(A)’’ and inserting ‘‘503(d)(2)(A)’’,

7 (4) in paragraph (5), by striking ‘‘because of

8 the sale’’ through ‘‘503(c)(1)’’ and inserting ‘‘of a

9 violation of section 503(c)’’, and

10 (5) by striking paragraphs (2), (3), and (4) and

11 redesignating paragraph (5) as paragraph (2).

12 SEC. 4. EFFECTIVE DATE AND REGULATIONS.

13 The amendments made by this Act shall take effect

14 upon the expiration of 180 days after the date of the en15 actment of this Act. During such 180 day period the Sec16 retary of Health and Human Services shall promulgate

17 regulations to implement the amendments made by this

18 Act. If final regulations are not promulgated before the

19 expiration of such 180 days, the Secretary may not take

20 any action to prevent a program, established before the

21 expiration of such days, from providing a drug or a coupon

22 for a drug to patients who would not otherwise be able

23 financially to use such drug.

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