Proposed FDA Recall Authority in H.R.5874 - Counterfeit Drug Enforcement Act of 2014 is Needed. Here is the language:

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.''.
                                 <all>

quoted from H.R.5874 - Counterfeit Drug Enforcement Act of 2014