[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5874 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 5874
To amend the Federal Food, Drug, and Cosmetic Act to increase criminal
penalties for the sale or trade of prescription drugs knowingly caused
to be adulterated or misbranded, to establish recall authority
regarding drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 11, 2014
Mr. Israel introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to increase criminal
penalties for the sale or trade of prescription drugs knowingly caused
to be adulterated or misbranded, to establish recall authority
regarding drugs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as ``Tim Fagan's Law'' or the ``Counterfeit
Drug Enforcement Act of 2014''.
SEC. 2. SALE OR TRADE OF PRESCRIPTION DRUGS KNOWINGLY CAUSED TO BE
ADULTERATED OR MISBRANDED; MISREPRESENTATION AS APPROVED
DRUGS.
(a) Criminal Penalty.--Section 303(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333(a)) is amended by adding at the end the
following paragraphs:
``(3) Notwithstanding paragraph (1) or (2), in the case of a person
who violates subsection (a), (b), or (c) of section 301 with respect to
a drug that is subject to section 503(b)(1)(B), if the person knowingly
caused the drug to be adulterated or misbranded and sells or trades the
drug, or the person purchases or trades for the drug knowing or having
reason to know that the drug was knowingly caused to be adulterated or
misbranded, the person shall be fined in accordance with title 18,
United States Code, or imprisoned for any term of years or for life, or
both.
``(4) Notwithstanding paragraph (1) or (2), in the case of a person
who violates section 301(d) with respect to a drug, if the person
caused the drug to be misrepresented as a drug that is subject to
section 503(b)(1)(B) and for which an approved application is in effect
under section 505 and the person sells or trades the drug, or the
person purchases or trades for the drug knowing or having reason to
know that the drug was knowingly caused to be so misrepresented, the
person shall be fined in accordance with title 18, United States Code,
or imprisoned for any term of years or for life, or both.''.
(b) Notification of Food and Drug Administration by
Manufacturers.--Section 505(k) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(k)) is amended by adding at the end the following
paragraph:
``(6) A manufacturer of a drug that receives or otherwise becomes
aware of information that reasonably suggests that a violation
described in paragraph (3) or (4) of section 303(a) may have occurred
with respect to the drug shall report such information to the Secretary
not later than 48 hours after first receiving or otherwise becoming
aware of the information.''.
SEC. 3. USE OF TECHNOLOGIES FOR PREVENTING COUNTERFEITING OF DRUGS.
Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352) is amended by adding at the end the following:
``(dd) If it is a drug and it is not manufactured in accordance
with any regulations of the Secretary requiring the use of technologies
that the Secretary has determined are technically feasible and will
assist in preventing violations of this Act to which paragraphs (3) and
(4) of section 303(a) apply (relating to the knowing adulteration or
misbranding of drugs and the knowing misrepresentation of drugs).''.
SEC. 4. COUNTERFEIT DRUGS; INCREASED FUNDING FOR INSPECTIONS,
EXAMINATIONS, AND INVESTIGATIONS.
For the purpose of increasing the capacity of the Food and Drug
Administration to conduct inspections, examinations, and investigations
under the Federal Food, Drug, and Cosmetic Act with respect to
violations described in paragraphs (3) and (4) of section 303(a) of
such Act, there is authorized to be appropriated $60,000,000 for each
of the fiscal years 2015 through 2018, in addition to other
authorizations of appropriations that are available for such purpose.
SEC. 5. PUBLIC EDUCATION REGARDING COUNTERFEIT DRUGS.
(a) In General.--The Secretary of Health and Human Services shall
carry out a program to educate the public and health care professionals
on counterfeit drugs, including techniques to identify drugs as
counterfeit.
(b) Authorization of Appropriations.--For the purpose of carrying
out subsection (a), there is authorized to be appropriated $5,000,000
for each of the fiscal years 2015 through 2018, in addition to other
authorizations of appropriations that are available for such purpose.
SEC. 6. RECALL AUTHORITY REGARDING DRUGS.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F
the following section:
``SEC. 506G. RECALL AUTHORITY.
``(a) Order To Cease Distribution of Drug; Notification of Health
Professionals.--
``(1) In general.--If the Secretary finds that a drug
intended for human use may constitute a threat to the public
health, the Secretary shall issue an order requiring the
appropriate person (including the manufacturers, importers,
distributors, or retailers of the drug)--
``(A) to immediately cease distribution of the
drug; and
``(B) to immediately notify health professionals of
the order and to instruct such professionals to cease
administering, distributing, selling, or prescribing
the drug.
``(2) Informal hearing.--An order under paragraph (1) shall
provide the person subject to the order with an opportunity for
an informal hearing, to be held not later than 10 days after
the date of the issuance of the order, on the actions required
by the order and on whether the order should be amended to
require a recall of the drug involved. If, after providing an
opportunity for such a hearing, the Secretary determines that
inadequate grounds exist to support the actions required by the
order, the Secretary shall vacate the order.
``(b) Order To Recall Drug.--
``(1) In general.--If, after providing an opportunity for
an informal hearing under subsection (a)(2), the Secretary
determines that the order should be amended to include a recall
of the drug with respect to which the order was issued, the
Secretary shall, except as provided in paragraphs (2) and (3),
amend the order to require a recall. The Secretary shall
specify a timetable in which the drug recall will occur and
shall require periodic reports to the Secretary describing the
progress of the recall.
``(2) Certain actions.--An amended order under paragraph
(1)--
``(A) shall not require recall of a drug from
individuals; and
``(B) shall provide for notice to individuals
subject to the risks associated with the use of the
drug.
``(3) Assistance of health professionals.--In providing the
notice required by paragraph (2)(B), the Secretary may use the
assistance of health professionals who administered the drug
involved to individuals or prescribed the drug for individuals.
If a significant number of such individuals cannot be
identified, the Secretary shall notify such individuals
pursuant to section 705(b).''.
SEC. 7. AUTHORITY TO ISSUE SUBPOENAS WITH RESPECT TO PREVENTING THREATS
TO THE PUBLIC HEALTH.
Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
333(a)) is amended by adding at the end the following subsection:
``(h) The Secretary and the Attorney General shall develop and
implement a procedure through which the Chief Counsel in the Food and
Drug Administration is authorized to issue subpoenas regarding
investigations under this Act of acts or omissions that may constitute
a threat to the public health, including investigations of alleged
violations to which paragraph (3) or (4) of subsection (a) apply and
alleged violations with respect to which the Secretary is considering
the use of authorities under section 304.''.
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