```

[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 2168 Introduced in Senate (IS)]

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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE AND REFERENCE.

    (A) Short Title.--This Act may be cited as the ``Prescription Drug 
Marketing Reform Act of 1994''.
    (b) Reference.--Whenever in this Act an amendment or repeal is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section or 
other provision of the Federal Food, Drug, and Cosmetic Act.

SEC. 2. PROHIBITION OF DRUG SAMPLES.

    Section 503 (21 U.S.C. 353) is amended--
            (1) in the first sentence of subsection (c)(1), by 
        inserting ``distribute,'' after ``No person may'',
            (2) in the second sentence of such subsection, by striking 
        ``and subsection (d)'',
            (3) by inserting after the second sentence of such 
        subsection the following: ``For purposes of this subsection, 
        the term `distribute' does not include providing a drug sample 
        to enable a practitioner licensed to prescribe a drug subject 
        to subsection (b) or a health care professional acting under 
        the direction and supervision of such a practitioner to provide 
        for the dispensing of or to dispense a sample of such drug if 
        the sample is made available to a patient in accordance with 
        regulations of the Secretary specifying conditions under which 
        such drug is necessary for medical care.'',
            (4) in paragraph (2), by inserting ``distribute,'' after 
        ``No person may'',
            (5) by redesignating paragraph (3) as paragraph (4) and by 
        adding after paragraph (2) the following:
    ``(3) Nothing in paragraphs (1) and (2) precludes distribution of a 
drug subject to subsection (b) at no cost or nominal cost pursuant to a 
program established by the manufacturer or distributor of such drug to 
provide it to specific identified patients who, for financial reasons, 
would not otherwise have access to such drug. The Secretary shall 
promulgate regulations to specify the documentation and record keeping 
required for such a program.'', and
            (6) by repealing subsection (d) and redesignating 
        subsections (e), (f), and (g) as subsections (d), (e), and (f), 
        respectively.

SEC. 3. ENFORCEMENT.

    (a) Prohibited Act.--Section 301(t) (21 U.S.C. 331(t)) is amended 
to read as follows:
    ``(t) the importation of a drug in violation of section 801(d)(1), 
the distribution, sale, purchase, or trade of a drug or drug sample or 
the offer to distribute, sell, purchase, or trade a drug or drug sample 
in violation of section 503(c), the distribution, sale, purchase, or 
trade of a coupon or the offer to distribute, sell, purchase, or trade 
such a coupon in violation of section 503(c)(2), or the distribution of 
drugs in violation of section 503(d) or the failure to otherwise comply 
with the requirements of section 503(d).''.
    (b) Penalty.--Section 303(b) (21 U.S.C. 333(b)) is amended--
            (1) in subparagraph (B), by inserting ``distribute,'' after 
        ``knowingly'',
            (2) in subparagraph (C), by inserting ``distributing,'' 
        after ``knowingly'',
            (3) in subparagraph (D), by striking ``503(e)(2)(A)'' and 
        inserting ``503(d)(2)(A)'',
            (4) in paragraph (5), by striking ``because of the sale'' 
        through ``503(c)(1)'' and inserting ``of a violation of section 
        503(c)'', and
            (5) by striking paragraphs (2), (3), and (4) and 
        redesignating paragraph (5) as paragraph (2).

SEC. 4. EFFECTIVE DATE AND REGULATIONS.

    The amendments made by this Act shall take effect upon the 
expiration of 180 days after the date of the enactment of this Act. 
During such 180 day period the Secretary of Health and Human Services 
shall promulgate regulations to implement the amendments made by this 
Act. If final regulations are not promulgated before the expiration of 
such 180 days, the Secretary may not take any action to prevent a 
program, established before the expiration of such days, from providing 
a drug or a coupon for a drug to patients who would not otherwise be 
able financially to use such drug.

                                 <all>
```