Counterfeit Drug Enforcement Act of 2014

Summary: Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for a drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Department of Health and Human Services (HHS) within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred.  Deems a drug to be misbranded if it is not manufactured using technologies that HHS determines are technically feasible and assist in preventing such violations. Authorizes additional appropriations for Food and Drug Administration (FDA) inspections, examinations, and investigations. Requires HHS to educate the public and health care professionals on counterfeit drugs. Directs HHS, upon a finding that a drug intended for human use may constitute a threat to the public health, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering, distributing, selling, or prescribing the drug. Requires HHS, after providing the person with an opportunity for an informal hearing, to amend the order to include a recall, if appropriate. Requires HHS and the Attorney General to establish a procedure through which the FDA is authorized to issue subpoenas.

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.''.