[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5922 Introduced in House (IH)]








109th CONGRESS
  2d Session
                                H. R. 5922

    To amend the Federal Food, Drug, and Cosmetic Act to establish 
 additional authorities to ensure the safe and effective use of drugs, 
to establish whistleblower protections for certain individuals, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 27, 2006

  Mr. Markey 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 establish 
 additional authorities to ensure the safe and effective use of drugs, 
to establish whistleblower protections for certain individuals, 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 ``Swift Approval, Full Evaluation Drug 
Act'' or the ``SAFE Drug Act''.

SEC. 2. POSTMARKET STUDIES REGARDING DRUG SAFETY; POSTMARKET LABELING 
              CHANGES.

    (a) Postmarket Orders Regarding Studies.--Chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
inserting after section 505B the following section:

``SEC. 505C. POSTMARKET STUDIES REGARDING DRUG SAFETY.

    ``(a) Postmarket Orders.--Within 30 days after receiving evidence 
of a significant issue regarding the safety or lack of effectiveness of 
an approved drug, including reports of adverse events, studies 
conducted or reports released by the Food and Drug Administration, the 
National Institutes of Health, the Agency for Healthcare Research and 
Quality or another relevant agency, actions or reports by regulatory 
agencies in foreign countries, or studies or case reports published in 
scientific or academic journals, the Secretary, after providing public 
notice of the significant safety or effectiveness issue, may order the 
holder of the approved application to conduct a study or studies to 
address the issues involved. Each such notice and order shall be 
published in the Federal Register.
    ``(b) Restrictions on Use.--
            ``(1) In general.--An order under subsection (a) with 
        respect to an approved drug may, during the period in which the 
        study involved is conducted, establish restrictions on the 
        distribution or use of the drug if the Secretary determines 
        that such restrictions are necessary to ensure the safe use of 
        the drug during such period.
            ``(2) Certain authorities.--Restrictions that may be 
        established by the Secretary under paragraph (1) with respect 
        to a drug include the following:
                    ``(A) Restricting distribution to certain 
                facilities or physicians with special training or 
                experience.
                    ``(B) Conditioning distribution on the performance 
                of specified medical procedures.
                    ``(C) Restricting direct-to-consumer advertisements 
                for the drug.
            ``(3) Termination.--The Secretary may, on the basis of the 
        results of the study or other evidence, continue the 
        restrictions under paragraph (1), terminate restrictions 
        established or establish different restrictions, as necessary 
        to ensure the safe use of the drug. The Secretary shall notify 
        the sponsor of the decision to extend, terminate or change the 
        restrictions no later than 30 days after the date on which the 
        results of the study involved are submitted to the Secretary.
    ``(c) Definition.--For purposes of this section, the term `approved 
drug' means a drug for which an approved application under section 505 
is in effect or for which a biologics license under section 351 of the 
Public Health Service Act is in effect.''.
    (b) New Drug Applications; Postmarket Studies Pursuant to 
Accelerated Approval.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the 
following subsection:
    ``(o)(1) The Secretary shall amend subpart H of part 314 of title 
21, Code of Federal Regulations, to establish the following policies:
            ``(A) As a condition of the approval under such subpart of 
        a new drug on or after the date of the enactment of the SAFE 
        Drug Act, the Secretary shall require that one or more 
        postmarket studies of the drug be conducted.
            ``(B) The Secretary may not approve the application 
        involved unless--
                    ``(i) the sponsor has submitted to the Secretary 
                the protocols for each such study;
                    ``(ii) the Secretary has approved the protocols; 
                and
                    ``(iii) the Secretary and the sponsor have agreed 
                on a timeframe, including designated milestones, for 
                the prompt completion of the study, which timeframe 
                assumes due diligence by the sponsor in conducting the 
                study.
            ``(C) The Secretary shall require that, after the 
        application is approved under such subpart and the drug enters 
        commercial distribution, the drug be marketed in accordance 
        with the following:
                    ``(i) The distribution and use of the drug shall be 
                restricted in accordance with such subpart.
                    ``(ii) Until the Secretary determines that the 
                sponsor has fulfilled its commitments under 
                subparagraphs (A) and (B), the labeling of the drug 
                shall bear--
                            ``(I) a statement that the Food and 
                        Administration is requiring a study or studies 
                        to confirm the safety and effectiveness of the 
                        drug; and
                            ``(II) a statement providing a clear and 
                        concise summary of the outstanding issues or 
                        questions to be addressed in such required 
                        studies.
                    ``(iii) Until the Secretary determines that the 
                sponsor has fulfilled its commitments under 
                subparagraphs (A) and (B), the label of the drug shall 
                bear a statement providing as follows: `This product 
                received conditional approval from the FDA under its 
                accelerated approval process. It will not receive full 
                approval until completion of further testing to confirm 
                safety and/or efficacy. For further information please 
                contact your physician.'.
                    ``(iv) Direct-to-consumer advertisements for the 
                drug shall be restricted until--
                            ``(I) the Secretary determines that the 
                        sponsor has fulfilled its commitments under 
                        subparagraphs (A) and (B); and
                            ``(II) the drug has been approved under 
                        such part 314 independently of subpart H of 
                        such part.
    ``(2) The Secretary shall amend part 314 of title 21, Code of 
Federal Regulations, to establish the following policies regarding 
postmarket studies that, on or after the date of the enactment of the 
SAFE Drug Act, are required pursuant to approval of a new drug under 
subpart H of such part or under section 506(b)(2) of this Act:
            ``(A) If a required study is not completed by two years 
        after the date on which the new drug was so approved, the 
        Secretary shall, promptly after the expiration of such period, 
        convene a public meeting of the appropriate advisory committee 
        to review the progress of the study. Such review shall include 
        the assessment of compliance with the timeframe for prompt 
        completion of the study as agreed to by the company and the 
        Secretary under paragraph (1)(B)(iii) or under section 
        506(b)(2) (as the case may be), the quality of study conduct, 
        rates of enrollment overall and by institution, the barriers to 
        progress, and whether the sponsor is acting with due diligence. 
        At the meeting, the advisory committee shall determine whether 
        it is in the best interest of the public to allow the sponsor 
        to continue marketing the drug until the study is completed or 
        whether it is in the best interest of the public to suspend the 
        commercial marketing of the drug until the study is completed.
            ``(B) If the drug was approved on the basis of animal 
        efficacy data because human efficacy studies are not ethical or 
        feasible, the holder of the approved application shall conduct 
        studies when ethical and feasible to verify and describe 
        clinical benefit and to assess the product's safety.
            ``(C) If the results of a completed study that was so 
        required are inconclusive or the risk-to-benefit profile cannot 
        be positively established, the Secretary shall withdraw the 
        product for commercial distribution. If a required study is not 
        completed by eight years after the date of approval, the 
        results of the study are presumed to be inconclusive. The 
        product may only be made available to patients who--
                    ``(i) according to a health care professional have 
                previously benefitted from the product; and
                    ``(ii) have signed a statement of informed consent 
                stating that they have received notice from the sponsor 
                that the results of completed studies on the product 
                have proven to be inconclusive and/or the risk to 
                benefit profile can not be positively established. The 
                document shall include the risks of continuing the 
                product.
        Otherwise the product shall be unavailable except in a research 
        setting until the product can meet the same standard of safety 
        and effectiveness that exists for full approval.''.
    (c) Enforcement Regarding Postmarket Studies.--
            (1) Misbranding.--Section 502 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352) is amended by adding at the 
        end the following:
    ``(x) If it is a drug with respect to which there is a failure to 
comply with a requirement under section 505(o)(1), an order under 
section 505C, or a requirement under section 506(b)(2).''.
            (2) Civil penalties.--Section 303 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at 
        the end the following:
    ``(g)(1)(A) Any person who violates section 301(a), 301(b), or 
301(c) by reason of section 502(x) shall be subject to a civil penalty 
of not more than 100 percent of the gross profits received by the 
sponsor from sales of the drug, or $1,000,000, whichever is greater, 
subject to subparagraph (B).
    ``(B) If any harm to a consumer occurs as a result of a violation 
referred to in subparagraph (A), the person involved may be subject to 
a civil penalty of not more than an amount equal to 300 percent of the 
gross profits received by the person, or $3,000,000, whichever is 
greater.
    ``(2) Any person who fails to act with due diligence to complete a 
postmarket study required under section 506(b)(2), or under subpart H 
of part 314 of title 21, Code of Federal Regulations, shall be subject 
to a civil penalty of not more than the amount that applies under 
subparagraph (A) or subparagraph (B) of paragraph (1) (as the case may 
be) for a violation referred to in such paragraph. The Secretary shall 
by regulation define the term `due diligence' for purposes of this 
paragraph.
    ``(3) The provisions of paragraphs (3) through (5) of subsection 
(f) apply to a civil penalty under subparagraph (A) or (B) of paragraph 
(1) or under paragraph (2) to the same extent and in the same manner as 
such provisions apply to a civil penalty under paragraph (1) or (2) of 
such subsection.''.
    (d) Postmarket Labeling Changes.--Section 502 of the Federal Food, 
Drug, and Cosmetic Act, as amended by subsection (c)(1) of this 
section, is amended by adding at the end the following:
            ``(y) If it is a drug and the manufacturer of the drug or 
        product fails to make changes to a product's labeling in 
        compliance with an order of the Secretary, issued on the basis 
        of clinical evidence (including studies submitted to the 
        Secretary, an analysis of adverse events reports, studies 
        conducted or reports released by the Food and Drug 
        Administration, the National Institutes of Health, the Agency 
        for Healthcare Research and Quality or another relevant agency, 
        actions or reports by regulatory agencies in foreign countries, 
        or studies published in scientific or academic journals), that 
        the labeling of the drug be modified to include specific 
        wording required by the Secretary to ensure the safe and 
        effective use of the drug.''.
    (e) Rule of Construction Regarding Certain Pediatric Studies.--The 
amendments made by this section establish authorities in addition to, 
and not in lieu of--
            (1) the program under section 505A of the Federal Food, 
        Drug, and Cosmetic Act; and
            (2) authorities under section 505B of such Act.

SEC. 3. WHISTLEBLOWER PROTECTIONS.

    (a) Prohibition.--It shall be unlawful for any person to discharge, 
demote, suspend, reprimand, investigate, or take or fail to take any 
other personnel action that in any manner discriminates against any 
covered individual, or in any other manner discriminate against any 
covered individual (including by a denial, suspension, or revocation of 
a security clearance or by any other security access determination, or 
by denial of award of a Federal contract or subcontract), or to 
threaten or recommend the discharge, demotion, suspension, reprimand, 
investigation, other personnel action (or rejection of such action) 
that in any manner discriminates against any covered individual, or 
other manner of discrimination if such action, discrimination, or 
recommendation is due, in whole or in part, to any lawful act done, 
perceived to have been done, or intended to be done by the covered 
individual--
            (1) to provide information, cause information to be 
        provided, or otherwise assist in an investigation or proceeding 
        regarding any conduct which the covered individual reasonably 
        believes constitutes evidence of a violation of any law, rule, 
        or regulation, a substantial and specific threat to public 
        health or safety, abuse of authority, or fraud, waste, or 
        mismanagement of public funds, if the information or assistance 
        is provided to or the investigation or proceeding is conducted 
        by--
                    (A) a Federal, State, or local regulatory or law 
                enforcement agency (including an office of Inspector 
                General under the Inspector General Act of 1978);
                    (B) any Member of Congress, any committee of 
                Congress, or the Government Accountability Office;
                    (C) any person with supervisory or managerial 
                authority over the covered individual (or any other 
                person who has the authority to investigate, discover, 
                or terminate misconduct); or
                    (D) a potential witness to or other person affected 
                by or aware of the conduct described in this section 
                who has the authority to investigate, discover, or 
                terminate misconduct;
            (2) to file, cause to be filed, testify, participate in, or 
        otherwise assist in a proceeding or action filed or about to be 
        filed relating to an alleged violation of any law, rule, or 
        regulation; or
            (3) to refuse to violate or assist in the violation of any 
        law, rule, or regulation.
    (b) Enforcement Action.--
            (1) In general.--A covered individual who alleges discharge 
        or other discrimination by any person in violation of 
        subsection (a) may seek relief under subsection (c) by--
                    (A) filing a complaint with the Secretary of Labor; 
                or
                    (B) if the Secretary has not issued a final 
                decision within 180 days after the filing of the 
                complaint and there is no showing that such delay is 
                due to the bad faith of the claimant, bringing an 
                action at law or equity for de novo review in the 
                appropriate district court of the United States, which 
                shall have jurisdiction over such an action without 
                regard to the amount in controversy.
            (2) Procedure.--
                    (A) In general.--An action under paragraph (1)(A) 
                shall be governed under the rules and procedures set 
                forth in section 42121(b) of title 49, United States 
                Code.
                    (B) Exception.--Notification made under section 
                42121(b)(1) of title 49, United States Code, shall be 
                made--
                            (i) to the person named in the complaint; 
                        and
                            (ii) to the person's employer.
                    (C) Burdens of proof.--An action brought under 
                paragraph (1)(B) shall be governed by the legal burdens 
                of proof set forth in section 42121(b) of title 49, 
                United States Code.
                    (D) Statute of limitations.--An action under 
                paragraph (1) shall be commenced not later than 6 years 
                after the date on which the violation occurs.
    (c) Remedies.--
            (1) In general.--A covered individual prevailing in any 
        action under subsection (b) shall be entitled to all relief 
        appropriate to make the covered individual whole.
            (2) Damages.--Relief for any action under subsection (b) 
        shall include--
                    (A) reinstatement with the same seniority status 
                and employment grade or pay level (or the equivalent) 
                that the covered individual would have had, but for the 
                discrimination;
                    (B) compensatory damages, including the amount of 
                any back pay, with interest;
                    (C) compensation for any special damages sustained 
                as a result of the discrimination, including litigation 
                costs, expert witness fees, and reasonable attorney 
                fees; and
                    (D) punitive damages in an amount not to exceed the 
                greater of 3 times the amount of any monetary damages 
                awarded under this section (apart from this paragraph) 
                or $5,000,000.
    (d) Rights Retained by Covered Individual.--Nothing in this section 
shall be deemed to diminish the rights, privileges, or remedies of any 
covered individual under any Federal or State law, or under any 
collective bargaining agreement. The rights and remedies in this 
section may not be waived by any agreement, policy, form, or condition 
of employment.
    (e) Notification.--The provisions of this section shall be 
prominently posted in any place of employment to which this section 
applies.
    (f) Definitions.--For purposes of this section:
            (1) The term ``covered individual'' means an employee of 
        the Food and Drug Administration.
            (2) The term ``lawful'' means not specifically prohibited 
        by law.

SEC. 4. RIGHT TO PUBLISH.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the 
following section:

``SEC. 565. RIGHT TO PUBLISH.

    ``Officers and employees of the Food and Drug Administration, and 
individuals sponsored by such Administration, may publish in peer-
reviewed journals and other scientific publications, and make oral 
presentations at professional society meetings and other meetings of 
their peers, unless publication or presentation of the data is subject 
to Federal export control or national security laws or regulations, or 
is proprietary information. The right to publish or present such data 
cannot be waived by any agreement, policy, form or condition of 
employment.''.

SEC. 5. BIENNIAL REPORTS ON APPROVED APPLICATIONS SUPPORTED BY NON-
              INFERIORITY STUDIES.

    Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 2(b) of this Act, is amended by adding at the end the 
following subsection:
    ``(p) Biennial Reports on Approved Applications Supported by Non-
Inferiority Studies.--The Secretary shall submit to the Congress 
biennial reports on approved applications under subsection (b) 
(including supplemental applications) that have been supported by data 
from one or more non-inferiority studies. For each such application, 
the report shall include the following information:
            ``(1) The name of the drug listed in application.
            ``(2) The name of the sponsor.
            ``(3) The date of the approval.
            ``(4) The name of each drug used as an active control in 
        the non-inferiority studies used to support the application.
            ``(5) The indication studied.
            ``(6) The primary and secondary endpoints of the non-
        inferiority studies.
            ``(7) The margins used in such studies.
            ``(8) The explanation required by section 314.l26(b)(2)(iv) 
        of title 21, Code of Federal Regulations, as to why the drugs 
        should be considered effective in the study.''.

SEC. 6. BIANNUAL REPORTS REGARDING POSTMARKET STUDIES.

    Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 5 of this Act, is amended by adding at the end the following 
subsection:
    ``(q) Biannual Reports Regarding Postmarket Studies.--The Secretary 
shall submit to the Congress biannual reports that provide the 
following information:
            ``(1) The number of enforcement actions taken to ensure 
        that sponsors are complying with the requirements to complete 
        postmarketing studies under subsection (o) and sections 505C 
        and 506(b)(2), together with a description of each such action.
            ``(2) The measures taken by the Secretary to establish a 
        system to ensure effective monitoring of the status of all such 
        postmarketing studies, together with a description of the 
        status of that system.
            ``(3) The measures taken by the Secretary to develop a 
        system to track information about ongoing postmarketing safety 
        issues, together with a description of the status of that 
        system.''.
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