[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1165 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 1165

    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

                           February 16, 2007

  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 and 
        effective 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 a study ordered pursuant to subsection (a) 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 Drug 
                        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 labeling 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 and 
        effectiveness.
            ``(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 five years after the date of approval, the results 
        of the study are presumed to be inconclusive. The product may 
        only be made available to a patient who--
                    ``(i) according to a health care professional has 
                previously benefitted from the product; and
                    ``(ii) has signed a statement of informed consent 
                that--
                            ``(I) states that the patient has received 
                        notice from the sponsor that the results of 
                        completed studies on the product have proven to 
                        be inconclusive or the risk-to-benefit profile 
                        cannot be positively established; and
                            ``(II) identifies 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:
    ``(y) 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(y) 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:
            ``(z) 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 (21 U.S.C. 355a); and
            (2) authorities under section 505B of such Act (21 U.S.C. 
        355b).

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, an abuse of authority, fraud, waste, or 
        mismanagement of public funds, censorship, distortion, or 
        suppression of scientific information, research, or analysis, 
        or the willful disclosure of false, misleading, or incomplete 
        scientific information, 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 paragraph (3) 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.
            (3) Remedies.--
                    (A) In general.--A covered individual prevailing in 
                any action under this subsection shall be entitled to 
                all relief appropriate to make the covered individual 
                whole.
                    (B) Damages.--Relief for any action under this 
                subsection shall include--
                            (i) 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;
                            (ii) compensatory damages, including the 
                        amount of any back pay, with interest;
                            (iii) compensation for any special damages 
                        sustained as a result of the discrimination, 
                        including litigation costs, expert witness 
                        fees, and reasonable attorney fees; and
                            (iv) 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.
    (c) Criminal Penalties.--
            (1) In general.--Any person who violates subsection (a) 
        shall be fined under title 18 of the United States Code, 
        imprisoned not more than 10 years, or both.
            (2) Reporting requirements.--The Attorney General of the 
        United States shall (based on such periodic reports and other 
        information from the Department of Labor as the Attorney 
        General may require) submit to the Congress an annual report on 
        the enforcement of paragraph (1). Each such report shall--
                    (A) identify each case in which formal charges 
                under paragraph (1) were brought;
                    (B) describe the status or disposition of each such 
                case; and
                    (C) in any action under subsection (b) in which the 
                covered individual was the prevailing party or the 
                substantially prevailing party, indicate whether or not 
                any formal charges under paragraph (1) have been 
                brought and, if not, the reasons therefor.
    (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 or a 
        contractor or subcontractor 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. PROVIDING FDA ADVISORY COMMITTEES WITH COMPLETE INFORMATION.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 4 of this Act, is amended by adding at the 
end the following section:

``SEC. 566. PROVIDING ADVISORY COMMITTEES WITH COMPLETE INFORMATION.

    ``(a) In General.--In conjunction with any hearing of an advisory 
committee of the Food and Drug Administration, the Secretary shall, at 
the request of any officer or employee of the Administration whose 
employment duties relate to the topic of the hearing, allow the officer 
or employee a reasonable amount of time to present to the advisory 
committee information on such topic.
    ``(b) Timing of Presentation.--An advisory committee shall provide 
a period of time to an officer or employee for a presentation under 
subsection (a) that is separate from the period of time allotted to the 
public for the hearing involved.''.

SEC. 6. PRESERVING SCIENTIFIC INTEGRITY.

    Subchapter E of chapter V 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 section:

``SEC. 567. PRESERVING SCIENTIFIC INTEGRITY.

    ``(a) Prohibition.--An officer or employee of the Food and Drug 
Administration shall not direct any other officer or employee of the 
Administration--
            ``(1) to censor, distort, or suppress any scientific 
        research, analysis, opinion, or recommendation; or
            ``(2) to willfully disclose scientific information that is 
        false, misleading, or incomplete.
    ``(b) Appropriate Disciplinary Action.--The Secretary shall subject 
any officer or employee who violates subsection (a) to appropriate 
disciplinary action (which may include dismissal).
    ``(c) Reporting by IG.--Not less than 1 year after the date of the 
enactment of this section, and annually thereafter, the Inspector 
General of the Department of Health and Human Services shall submit a 
report to the Congress--
            ``(1) identifying each disciplinary action under subsection 
        (b) during the preceding 12 months; and
            ``(2) describing the circumstances of each such 
        disciplinary action.''.

SEC. 7. TRANSPARENCY OF APPROVAL DECISIONS.

    Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 2(b) of this Act, is further amended by adding at the end 
the following:
    ``(p) Transparency of Approval Decisions.--
            ``(1) Summary statement.--Not later than 48 hours after the 
        approval of an application filed under subsection (b) or (j), 
        the Secretary shall publish a summary statement of the 
        scientific basis for such approval and how the final decision 
        balanced the risks and benefits.
            ``(2) Contents.--A summary statement under paragraph (1) 
        shall be dated and shall include the following:
                    ``(A) A summary of the factual, scientific, and 
                related issues considered during the approval process, 
                including--
                            ``(i) an explanation of the risks and the 
                        benefits of the drug involved; and
                            ``(ii) the scientific rationale for the 
                        final decision.
                    ``(B) Identification by name of each officer or 
                employee of the Food and Drug Administration who 
                participated in the decision to approve the 
                application.
                    ``(C) A description of--
                            ``(i) any significant controversy or 
                        difference of opinion between two or more 
                        officers or employees described in subparagraph 
                        (B) relating to the decision to approve the 
                        application; and
                            ``(ii) the resolution of each such 
                        controversy or difference of opinion.
            ``(3) Dissenting and other views.--Any officer or employee 
        of the Food and Drug Administration who participates in the 
        decision to approve an application filed under subsection (b) 
        or (j) may submit a statement of views on the matter for 
        inclusion in the applicable summary statement. Upon receipt of 
        such a statement of views, the Secretary shall attach the 
        statement of views, without alteration, as an addendum to the 
        summary statement.
            ``(4) Subsequent changes.--After publication of a summary 
        statement under this subsection, the Secretary--
                    ``(A) shall not alter the text of the summary 
                statement; and
                    ``(B) may prepare a description of changes to the 
                summary statement in a separate document and attach the 
                document as an addendum to the summary statement.
            ``(5) Confidential information.--This subsection does not 
        authorize the disclosure of any trade secret or privileged or 
        confidential commercial or financial information described in 
        section 552(b)(4) of title 5, United States Code, unless the 
        Secretary determines that such disclosure is necessary to 
        protect the public health.''.

SEC. 8. BIENNIAL REPORTS ON APPROVED APPLICATIONS SUPPORTED BY NON-
              INFERIORITY STUDIES.

    Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 7 of this Act, is amended by adding at the end the following 
subsection:
    ``(q) 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. 9. BIANNUAL REPORTS REGARDING POSTMARKET STUDIES.

    Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 8 of this Act, is amended by adding at the end the following 
subsection:
    ``(r) 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.''.
                                 <all>