[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 870 Introduced in House (IH)]






109th CONGRESS
  1st Session
                                H. R. 870

 To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced 
criminal penalties for certain violations of the Act involving knowing 
 concealment of evidence of a serious adverse drug experience, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 16, 2005

 Mr. Stark (for himself and Mr. Berry) 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 provide enhanced 
criminal penalties for certain violations of the Act involving knowing 
 concealment of evidence of a serious adverse drug experience, 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 the ``Pharmaceutical Research and 
Manufacturers Accountability Act of 2005'' or the ``PhRMA Act of 
2005''.

SEC. 2. CONCEALMENT OF SERIOUS ADVERSE DRUG EXPERIENCE.

    (a) Penalty for Knowing Concealment of Serious Adverse Drug 
Experience.--Section 303 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 333) is amended by adding at the end the following:
    ``(h) An individual who violates a provision of section 301 shall 
be imprisoned for a term of a minimum of 20 years and a maximum of 
life, fined not more than $2,000,000, or both, if--
            ``(1) the individual is employed as the chief executive 
        officer or a member of the senior executive management group of 
        the manufacturer of a drug; and
            ``(2) the violation involves, with respect to such drug, 
        knowing concealment by the individual of evidence of a serious 
        adverse drug experience (as that term is defined in section 
        505(o)).''.
    (b) Annual Attestation by CEO Regarding Any Serious Adverse Drug 
Experience.--The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) is amended--
            (1) in section 505 (21 U.S.C. 355), by adding at the end 
        the following:
    ``(o) Annual Attestation by CEO Regarding Any Serious Adverse Drug 
Experience.--
            ``(1) Requirement.--For each drug for which an approval of 
        an application filed under subsection (b) or (j) is in effect, 
        the Secretary shall require the chief executive officer of the 
        manufacturer of the drug to submit a separate, written 
        attestation on an annual basis--
                    ``(A) stating that the manufacturer has disclosed 
                to the Secretary all evidence of any serious adverse 
                drug experience related to the drug; and
                    ``(B) describing the process by which the 
                manufacturer ensures that such disclosure has occurred.
            ``(2) Definitions.--For purposes of this subsection:
                    ``(A) The term `evidence of any serious adverse 
                drug experience' includes any evidence of a serious 
                adverse drug experience that--
                            ``(i) is obtained by the manufacturer 
                        involved from any source of information, 
                        foreign or domestic, including any information 
                        obtained from a clinical trial conducted before 
                        or after approval of the drug, from 
                        postmarketing surveillance of the drug, or from 
                        a postmarketing report by a physician; or
                            ``(ii) is required by any provision of this 
                        Act to be reported by the manufacturer to the 
                        Secretary.
                    ``(B) The term `serious adverse drug experience' 
                means an adverse drug experience occurring at any dose 
                that results in--
                            ``(i) death, a life-threatening adverse 
                        drug experience, inpatient hospitalization, 
                        prolongation of existing hospitalization, a 
                        persistent or significant disability or 
                        incapacity, or a congenital anomaly or birth 
                        defect; or
                            ``(ii) a medical event that, based on 
                        appropriate medical judgment, may jeopardize 
                        the patient or subject and may require medical 
                        or surgical intervention to prevent one of the 
                        outcomes listed in clause (i).
            ``(3) Initial attestation.--The Secretary shall require 
        that the first attestation under this subsection for a drug be 
        submitted--
                    ``(A) in the case of a drug for which approval of 
                an application filed under subsection (b) or (j) is in 
                effect on the date of the enactment of this subsection, 
                not later than 1 year after such date; and
                    ``(B) in the case of any other drug, not later than 
                1 year after the the date of such approval for the 
                drug.
            ``(4) Failure to submit.--If the chief executive officer of 
        a manufacturer of a drug for which an approval of an 
        application filed under subsection (b) or (j) is in effect 
        fails to submit a timely attestation for the drug as required 
        by paragraph (1), the Secretary--
                    ``(A) may issue an order withdrawing approval of 
                the application; and
                    ``(B) shall not revoke such an order, or otherwise 
                approve or reinstate the application, unless--
                            ``(i) the Secretary conducts a review of 
                        the drug's safety;
                            ``(ii) the Secretary determines that the 
                        drug is safe for use; and
                            ``(iii) the manufacturer reimburses the 
                        Secretary for the costs of such review and 
                        determination.
            ``(5) Supplemental information.--In conducting a review 
        under paragraph (4)(B)(i), the Secretary may require the 
        manufacturer of the drug involved to submit supplemental 
        information on the drug's safety.'';
            (2) in section 301 (21 U.S.C. 331), by inserting at the end 
        the following:
    ``(hh) The failure to submit an attestation in accordance with 
section 505(o).''; and
            (3) in section 303 (21 U.S.C. 333), as amended by 
        subsection (a), by adding at the end the following:
    ``(i)(1) A person who violates section 301(hh) by failing to submit 
an attestation in accordance with section 505(o) shall be fined--
            ``(A) in the case of an individual, in accordance with 
        title 18, United States Code; and
            ``(B) in the case of any other person, not more than 
        $1,000,000.
    ``(2) Each 30-day period during which such violation continues 
shall constitute a separate offense.''.
    (c) Deadline for Postmarketing Studies.--
            (1) In general.--The Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 301 et seq.) is amended--
                    (A) in section 505 (21 U.S.C. 355), as amended by 
                subsection (b)(1), by adding at the end the following:
    ``(p) Deadline for Postmarketing Studies of Drugs.--
            ``(1) Requirement.--If the Secretary requires the 
        manufacturer or sponsor of a drug to conduct a postmaketing 
        study of the drug, the Secretary shall require the manufacturer 
        or sponsor to complete the study by a specified deadline.
            ``(2) Extension.--On request, the Secretary may extend a 
        deadline established under this subsection.'';
                    (B) in section 301 (21 U.S.C. 331), as amended by 
                subsection (b)(2), by inserting at the end the 
                following:
    ``(ii) The failure to complete a postmarketing study by the 
deadline established by the Secretary for such study under section 
505(p).''; and
                    (C) in section 303 (21 U.S.C. 333), as amended by 
                subsections (a) and (b)(3), by adding at the end the 
                following:
    ``(j) A person who violates section 301(ii) by failing to complete 
a postmarketing study for a drug by the deadline established by the 
Secretary for such study under section 505(p) shall be fined not more 
than $5,000,000. Each 30-day period during which such violation 
continues shall constitute a separate offense.''.
            (2) Application.--The amendments made by this subsection 
        apply only with respect to a drug for which an application is 
        filed under subsection (b) or (j) of section 505 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 33) on or after the 
        date of the enactment of this Act.
    (d) Prohibition Against Indemnification.--No person shall indemnify 
the chief executive officer of a drug manufacturer or any other 
individual for any fine incurred under the amendments made by this Act.
                                 <all>