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Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Counterfeit Drug Enforcement Act''.

SEC. 2. 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 506C
the following section:

''SEC. 506D. RECALL AUTHORITY.

''(a) Order to Cease Distribution of Drug; Notification of Health
Professionals.--
''(1) In general.--If the Secretary finds that there is a
reasonable probability that a drug intended for human use would
cause serious, adverse health consequences or death, 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 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 include 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. 3. SALE OR TRADE OF PRESCRIPTION DRUGS KNOWINGLY CAUSED TO BE
ADULTERATED OR MISBRANDED; KNOWING PURCHASE OR TRADE.

(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 paragraph:
''(3) Notwithstanding paragraph (1) or (2), in the case of a person
who violates section 301(a), 301(b), or 301(c) 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.''.
(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:
''(3) A manufacturer of a drug that receives or otherwise becomes
aware of information that reasonably suggests that a violation
described in section 303(a)(3) 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.''.
(c) 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 section 303(a)(3) of such Act, there
is authorized to be appropriated $60,000,000 for each of the fiscal
years 2004 through 2008, in addition to other authorizations of
appropriations that are available for such purpose.

SEC. 4. OTHER CRIMINAL PENALTIES; CLARIFICATION REGARDING FINES.

Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
333) is amended--
(1) in subsection (a)--
(A) in paragraph (1), by striking ''shall be
imprisoned'' and all that follows and inserting the
following: ''shall be fined in accordance with title
18, United States Code, or imprisoned not more than one
year, or both.''; and
(B) in paragraph (2), by striking ''shall be
imprisoned'' and all that follows and inserting the
following: ''shall be fined in accordance with title
18, United States Code, or imprisoned not more than
three years, or both.''; and
(2) in subsection (b)(1), in the matter after and below
subparagraph (D), by striking ''shall be imprisoned'' and all
that follows an inserting the following: ''shall be fined in
accordance with title 18, United States Code, or imprisoned not
more than 10 years, or both.''.
A:
Counterfeit Drug Enforcement Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services, upon a finding of reasonable probability that a drug intended for human use would cause serious health consequences or death, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to: (1) cease distribution of the drug; (2) notify health professionals of the order and instruct such professionals to cease administering or prescribing the drug; and (3) amend the order to include a recall if necessary.

Provides a criminal fine and/or imprisonment for a person who knowingly caused a prescription drug to be adulterated or misbranded and sells or trades the drug, or who purchased or traded for the drug knowing or having reason to know that the drug was knowingly adulterated or misbranded.

Provides additional funding for Food and Drug Administration (FDA) inspections and investigations.

Modifies provisions pertaining to criminal penalties for committing certain prohibited acts involving food, drugs, devices, or cosmetics to: (1) make a violation punishable by a fine in accordance with Federal criminal law, imprisonment for not more than one year, or both; (2) make a second violation, or a violation committed with intent to defraud or mislead, punishable by a fine in accordance with Federal criminal law, imprisonment for not more than three years, or both; and (3) make a violation of provisions pertaining to prescription drug marketing punishable by a fine in accordance with Federal criminal law, imprisonment for not more than ten years, or both.