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 amend-
ed 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 retail-
ers of the drug)— 
‘‘(A) to immediately cease distribution of 
the drug; and 
‘‘(B) to immediately notify health profes-
sionals of the order and to instruct such profes-
sionals to cease administering, distributing, sell-
ing, 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, 
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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 op-
portunity 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 Sec-
retary 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
PROFES-
SIONALS.—In providing the notice required by para-
graph (2)(B), the Secretary may use the assistance 
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of health professionals who administered the drug 
involved to individuals or prescribed the drug for in-
dividuals. 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 au-
thorized 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 vio-
lations to which paragraph (3) or (4) of subsection (a) 
apply and alleged violations with respect to which the Sec-
retary is considering the use of authorities under section 
304.’’. 
Æ 
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