[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4429 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 4429

To amend the Federal Food, Drug, and Cosmetic Act with respect to drug 
                    safety, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 18, 2005

  Mr. Tierney (for himself and Mr. Ramstad) 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 with respect to drug 
                    safety, 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 ``Food and Drug Administration Safety 
Act of 2005''.

SEC. 2. CENTER FOR POSTMARKET DRUG EVALUATION AND RESEARCH.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506C 
the following:

``SEC. 507. DRUG SAFETY.

    ``(a) Establishment of the Center for Postmarket Drug Evaluation 
and Research.--There is established within the Food and Drug 
Administration a Center for Postmarket Drug Evaluation and Research 
(referred to in the section as the `Center'). The Director of the 
Center shall report directly to the Commissioner of Food and Drugs.
    ``(b) Duties of the Center for Postmarket Drug Evaluation and 
Research.--
            ``(1) Responsibilities of director.--The Director of the 
        Center shall--
                    ``(A) conduct postmarket risk assessment of drugs 
                approved under section 505 of this Act and of 
                biological products licensed under section 351 of the 
                Public Health Service Act;
                    ``(B) conduct and improve postmarket surveillance 
                of approved drugs and licensed biological products 
                using postmarket surveillance programs and activities 
                (including MedWatch), risk-benefit analyses, adverse 
                event reports, the scientific literature, any clinical 
                or observational studies (including studies required 
                under subsection (d) or (e)), and any other resources 
                that the Director of the Center determines appropriate;
                    ``(C) determine whether a study is required under 
                subsection (d) or (e) and consult with the sponsors of 
                drugs and biological products to ensure that such 
                studies are completed by the date, and according to the 
                terms, specified by the Director of the Center;
                    ``(D) contract, or require the sponsor of an 
                application or the holder of an approved application or 
                license to contract, with the holders of domestic and 
                international surveillance databases to conduct 
                epidemiologic and other observational studies;
                    ``(E) determine, based on postmarket surveillance 
                programs and activities (including MedWatch), risk-
                benefit analyses, adverse event reports, the scientific 
                literature, and any clinical or observational studies 
                (including studies required under subsection (d) or 
                (e)), and any other resources that the Director of the 
                Center determines appropriate, whether a drug or 
                biological product may present an unreasonable risk to 
                the health of patients or the general public, and take 
                corrective action if such an unreasonable risk may 
                exist;
                    ``(F) make information about the safety and 
                effectiveness of approved drugs and licensed biological 
                products available to the public and healthcare 
                providers in a timely manner; and
                    ``(G) conduct other activities as the Director of 
                the Center determines appropriate to ensure the safety 
                and effectiveness of all drugs approved under section 
                505 and all biological products licensed under section 
                351 of the Public Health Service Act.
            ``(2) Determination of unreasonable risk.--In determining 
        whether a drug or biological product may present an 
        unreasonable risk to the health of patients or the general 
        public, the Director of the Center shall consider the risk in 
        relation to the known benefits of such drug or biological 
        product.
    ``(c) Secretarial Authority.--
            ``(1) In general.--Approval of a drug under section 505 of 
        this Act or issuance of a license for a biological product 
        under section 351 of the Public Health Service Act may be 
        subject to the requirement that the sponsor conduct 1 or more 
        postmarket studies as described in subsection (d) or (e) of 
        this section, or other postmarket studies as required by the 
        Secretary, to validate the safety and effectiveness of the drug 
        or biological product.
            ``(2) Definition.--For purposes of this section, the term 
        `postmarket' means--
                    ``(A) with respect to a drug, after approval of an 
                application under section 505; and
                    ``(B) with respect to a biological product, after 
                licensure under section 351 of the Public Health 
                Service Act.
    ``(d) Preapproval Review.--
            ``(1) Review of application.--
                    ``(A) In general.--
                            ``(i) Review.--At any time before a drug is 
                        approved under section 505 of this Act or a 
                        biological product is licensed under section 
                        351 of the Public Health Service Act, the 
                        Director of the Center shall review the 
                        application (or supplement to the application), 
                        and any analyses associated with the 
                        application, of such drug or biological 
                        product.
                            ``(ii) Effect of approval or licensure.--
                        The approval of a drug under section 505 or the 
                        licensure of a biological product under such 
                        section 351 shall not affect the continuation 
                        and completion of a review under clause (i).
                    ``(B) Limitation.--In no case shall the review 
                under subparagraph (A) delay a decision with respect to 
                an application for a drug under section 505 of this Act 
                or for a biological product under section 351 of the 
                Public Health Service Act.
            ``(2) Result of review.--The Director of the Center may, 
        based on the review under paragraph (1)--
                    ``(A) require that the sponsor of the application 
                agree to conduct 1 or more postmarket studies to 
                determine the safety or effectiveness of a drug or 
                biological product, including such safety or 
                effectiveness as compared to other drugs or biological 
                products, to be completed by a date, and according to 
                the terms, specified by the Director of the Center; or
                    ``(B) contract, or require the sponsor of the 
                application to contract, with a holder of a domestic or 
                an international patient database to conduct 1 or more 
                epidemiologic or other observational studies.
    ``(e) Postmarketing Studies of Drug Safety.--
            ``(1) In general.--At any time after a drug is approved 
        under section 505 of this Act or a biological product is 
        licensed under section 351 of the Public Health Service Act, 
        the Director of the Center, may--
                    ``(A) require that the holder of an approved 
                application or license conduct 1 or more studies to 
                determine the safety or effectiveness of such drug or 
                biological product, including such safety and 
                effectiveness as compared to other drugs or biological 
                products, to be completed by a date, and according to 
                the terms, specified by such Director; or
                    ``(B) contract, or require the holder of the 
                approved application or license to contract, with a 
                holder of a domestic or an international patient 
                database to conduct 1 or more epidemiologic or other 
                observational studies.
            ``(2) Review of outstanding studies.--Not later than 90 
        days after the date of enactment of the Food and Drug 
        Administration Safety Act of 2005, the Director of the Center 
        shall--
                    ``(A) review and publish a list in the Federal 
                Register of any postmarketing studies outstanding on 
                the date of enactment of the Food and Drug 
                Administration Safety Act of 2005; and
                    ``(B) as the Director determines appropriate, 
                require the sponsor of a study described in 
                subparagraph (A) to conduct such study under this 
                subsection.
    ``(f) Publication of Progress Reports and Completed Studies.--
            ``(1) In general.--The Director of the Center shall require 
        that the sponsor of a study under subsection (d) or (e) submit 
        to the Secretary--
                    ``(A) not less frequently than every 90 days, an 
                up-to-date report describing the progress of such 
                study; and
                    ``(B) upon the completion date of such study, the 
                results of such study.
            ``(2) Completion date.--For purposes of this section, the 
        completion date of such study shall be determined by the 
        Director of the Center.
    ``(g) Determinations by Director.--
            ``(1) Results of study.--The Director of the Center shall 
        determine, upon receipt of the results of a study required 
        under subsection (d) or (e)--
                    ``(A) whether the drug or biological product 
                studied may present an unreasonable risk to the health 
                of patients or the general public; and
                    ``(B) what, if any, corrective action under 
                subsection (k) shall be taken to protect patients and 
                the public health.
            ``(2) Results of evidence.--The Director of the Center may, 
        at any time, based on the empirical evidence from postmarket 
        surveillance programs and activities (including MedWatch), 
        risk-benefit analyses, adverse event reports, the scientific 
        literature, any clinical or observational studies (including 
        studies required under subsection (d) or (e)), or any other 
        resources that the Director of the Center determines 
        appropriate--
                    ``(A) make a determination that a drug or 
                biological product may present an unreasonable risk to 
                the health of patients or the general public; and
                    ``(B) order a corrective action under subsection 
                (k) be taken to protect patients and the public health.
            ``(3) Required consultation and considerations.--Before 
        making a determination under paragraph (2), ordering a study 
        under subsection (d) or (e), or taking a corrective action 
        under subsection (k), the Director of the Center shall--
                    ``(A) consult with the Director of the Center for 
                Drug Evaluation and Research or the Director of the 
                Center for Biologics Evaluation and Research, as 
                appropriate; and
                    ``(B) consider--
                            ``(i) the benefit-to-risk profile of the 
                        drug or biological product;
                            ``(ii) the effect that a corrective action, 
                        or failure to take corrective action, will have 
                        on the patient population that relies on the 
                        drug or biological product; and
                            ``(iii) the extent to which the drug or 
                        biological product presents a meaningful 
                        therapeutic benefit as compared to other 
                        available treatments.
    ``(h) Public Information.--Periodically, but not less often than 
every 90 days, the Secretary shall make available to the public, by 
publication in the Federal Register and posting on an Internet website, 
the following information:
            ``(1) Studies required under subsection (d) or (e) 
        including--
                    ``(A) the type of study;
                    ``(B) the nature of the study;
                    ``(C) the primary and secondary outcomes of the 
                study;
                    ``(D) the date the study was required under 
                subsection (d) or (e) or was agreed to by the sponsor;
                    ``(E) the deadline for completion of the study; and
                    ``(F) if the study has not been completed by the 
                deadline under subparagraph (E), a statement that 
                explains why.
            ``(2) The periodic progress reports and results of 
        completed studies described under subsection (f).
            ``(3) Any determinations made by the Director of the Center 
        under subsection (g), including--
                    ``(A) reasons for the determination, including 
                factual basis for such determination;
                    ``(B) reference to supporting empirical data; and
                    ``(C) an explanation that describes why contrary 
                data is insufficient.
    ``(i) Drug Advisory Committee.--The Drug Safety and Risk Management 
Drugs Advisory Committee within the Center of the Food and Drug 
Administration shall--
            ``(1) meet not less frequently than every 180 days; and
            ``(2) make recommendations to the Director of the Center 
        with respect to--
                    ``(A) which drugs and biological products should be 
                the subject of a study under subsection (d) or (e);
                    ``(B) the design and duration for studies under 
                subsection (d) or (e);
                    ``(C) which drugs and biological products may 
                present an unreasonable risk to the health of patients 
                or the general public; and
                    ``(D) appropriate corrective actions under 
                subsection (k).
    ``(j) Penalties.--
            ``(1) In general.--If the Secretary determines, after 
        notice and opportunity for an informal hearing, that a sponsor 
        of a drug or biological product or other entity has failed to 
        complete a study required under subsection (d) or (e) by the 
        date or to the terms specified by the Secretary under such 
        subsection, the Secretary may order such sponsor or other 
        entity to--
                    ``(A) complete the study in a specified time;
                    ``(B) revise the study to comply with the terms 
                specified by the Secretary under subsection (d) or (e); 
                or
                    ``(C) pay a civil penalty.
            ``(2) Amount of penalties.--
                    ``(A) In general.--The civil penalty ordered under 
                paragraph (1) shall be $250,000 for the first 30-day 
                period after the date specified by the Secretary that 
                the study is not completed, and shall double in amount 
                for every 30-day period thereafter that the study is 
                not completed.
                    ``(B) Limitation.--In no case shall a penalty under 
                subparagraph (A) exceed $2,000,000 for any 30-day 
                period.
            ``(3) Notification of penalty.--The Secretary shall publish 
        in the Federal Register any civil penalty ordered under this 
        subsection.
    ``(k) Result of Determination.--
            ``(1) In general.--If the Director of the Center makes a 
        determination that a drug or biological product may present an 
        unreasonable risk to the health of patients or the general 
        public under subsection (g), such Director shall order a 
        corrective action, as described under paragraph (2).
            ``(2) Corrective actions.--The corrective action described 
        under subsection (g)--
                    ``(A) may include--
                            ``(i) requiring a change to the drug or 
                        biological product label by a date specified by 
                        the Director of the Center;
                            ``(ii) modifying the approved indication of 
                        the drug or biological product to restrict use 
                        to certain patients;
                            ``(iii) placing restriction on the 
                        distribution of the drug or biological product 
                        to ensure safe use;
                            ``(iv) requiring the sponsor of the drug or 
                        biological product or license to establish a 
                        patient registry;
                            ``(v) requiring patients to sign a consent 
                        form prior to receiving a prescription of the 
                        drug or biological product;
                            ``(vi) requiring the sponsor to monitor 
                        sales and usage of the drug or biological 
                        product to detect unsafe use;
                            ``(vii) requiring patient or physician 
                        education; and
                            ``(viii) requiring the establishment of a 
                        risk management plan by the sponsor; and
                    ``(B) shall include the requirements with respect 
                to promotional material under subsection (l)(1).
            ``(3) Penalties.--
                    ``(A) In general.--If the Secretary determines, 
                after notice and opportunity for an informal hearing, 
                that a sponsor of a drug or biological product has 
                failed to take the corrective action ordered by the 
                Director of the Center under this subsection or has 
                failed to comply with subsection (l)(2), the Secretary 
                may order such sponsor to pay a civil penalty.
                    ``(B) Amount of penalties.--
                            ``(i) In general.--The civil penalty order 
                        under subparagraph (A) shall be $250,000 for 
                        the first 30-day period that the sponsor does 
                        not comply with the order under paragraph (1), 
                        and shall double in amount for every 30-day 
                        period thereafter that the order is not 
                        complied with.
                            ``(ii) Limitation.--In no case shall a 
                        penalty under clause (i) exceed $2,000,000 for 
                        any 30-day period.
                    ``(C) Notification of penalty.--The Secretary shall 
                publish in the Federal Register any civil penalty 
                ordered under this paragraph.
    ``(l) Promotion Material.--
            ``(1) Safety issue.--If the Director of the Center makes a 
        determination that a drug or biological product may present an 
        unreasonable risk to the health of patients or the general 
        public under subsection (g), such Director, in consultation 
        with the Division of Drug Marketing, Advertising, and 
        Communications of the Food and Drug Administration, shall--
                    ``(A) notwithstanding section 502(n), require that 
                the sponsor of such drug or biological product submit 
                to the Director of the Center copies of all promotional 
                material with respect to the drug or biological product 
                not less than 30 days prior to the dissemination of 
                such material; and
                    ``(B) require that all promotional material with 
                respect to the drug or biological product include 
                certain disclosures, which shall be displayed 
                prominently and in a manner easily understood by the 
                general public, including--
                            ``(i) a statement that describes the 
                        unreasonable risk to the health of patients or 
                        the general public as determined by the 
                        Director of the Center;
                            ``(ii) a statement that encourages patients 
                        to discuss potential risks and benefits with 
                        their healthcare provider;
                            ``(iii) a description of the corrective 
                        actions required under subsection (k);
                            ``(iv) where appropriate, a statement 
                        explaining that there may be products available 
                        to treat the same disease or condition that 
                        present a more favorable benefit-to-risk 
                        profile, and that patients should talk to their 
                        healthcare provider about the risks and 
                        benefits of alternative treatments;
                            ``(v) a description of any requirements of 
                        outstanding clinical and observational studies, 
                        including the purpose of each study; and
                            ``(vi) contact information to report a 
                        suspected adverse reaction.
            ``(2) New products; outstanding studies.--For the first 2-
        year period after a drug is approved under section 505 of this 
        Act or a biological product is licensed under section 351 of 
        the Public Health Service Act, and with respect to drugs and 
        biological products for which there are outstanding study 
        requirements under subsection (d) or (e), the Director of the 
        Center, in consultation with the Division of Drug Marketing, 
        Advertising, and Communications of the Food and Drug 
        Administration, shall--
                    ``(A) notwithstanding section 502(n), require that 
                the sponsor of such drug or biological product submit 
                to the Director of the Center copies of all promotional 
                material with respect to the drug or biological product 
                not less than 30 days prior to the dissemination of 
                such material; and
                    ``(B) require that all promotional material with 
                respect to the drug or biological product include 
                certain disclosures, which shall be displayed 
                prominently and in a manner easily understood by the 
                general public, including--
                            ``(i) a statement explaining that the drug 
                        or biological product is newly approved or 
                        licensed or the subject of outstanding clinical 
                        or observational studies, as the case may be, 
                        and, as a result, not all side effects or drug 
                        interactions may be known;
                            ``(ii) the number of people in which the 
                        drug or biological product has been studied and 
                        the duration of time during which the drug or 
                        biological product has been studied;
                            ``(iii) a statement that encourages 
                        patients to discuss the potential risks and 
                        benefits of treatment with their healthcare 
                        provider;
                            ``(iv) a description of any requirements of 
                        outstanding clinical and observational studies, 
                        including the purpose of each study; and
                            ``(v) contact information to report a 
                        suspected adverse reaction.
            ``(3) Effect of voluntary submission.--Paragraphs (1)(A) 
        and (2)(A) shall not apply to the sponsor of a drug or 
        biological product if such sponsor has voluntarily submitted to 
        the Division of Drug Marketing, Advertising, and Communications 
        of the Food and Drug Administration all promotional material 
        with respect the drug or biological product prior to the 
        dissemination of such material.
    ``(m) Withdrawal or Suspension of Approval or Licensure.--
            ``(1) In general.--The Director of the Center, may withdraw 
        or suspend approval of a drug or license of a biological 
        product using expedited procedures (as prescribed by the 
        Secretary in regulations promulgated not later than 1 year 
        after the date of enactment of the Food and Drug Administration 
        Safety Act of 2005, which shall include an opportunity for an 
        informal hearing) after consultation with the Director of 
        Center for Drug Evaluation and Research or the Director of the 
        Center for Biologics Evaluation and Research, as appropriate, 
        and any other person as determined appropriate by the Director 
        of the Center, if--
                    ``(A) the Director of the Center makes a 
                determination that the drug or biological product may 
                present an unreasonable risk to the health of patients 
                or the general public, and that risk cannot be 
                satisfactorily alleviated by a corrective action under 
                subsection (k); or
                    ``(B) the sponsor fails to comply with an order or 
                requirement under this section.
            ``(2) Public information.--The Secretary shall make 
        available to the public, by publication in the Federal Register 
        and posting on an Internet website, the details of the 
        consultation described in paragraph (1), including--
                    ``(A) the reason for the determination to withdraw, 
                suspend, or failure to withdraw or suspend, approval 
                for the drug or licensure for the biological product;
                    ``(B) the factual basis for such determination;
                    ``(C) reference to supporting empirical data;
                    ``(D) an explanation that describes why contrary 
                data is insufficient; and
                    ``(E) the position taken by each individual 
                consulted.
    ``(n) Effect of Section.--The authorities conferred by this section 
shall be separate from and in addition to the authorities conferred by 
section 505B.
    ``(o) Administration of Section.--The provisions of this section 
shall be carried out by the Secretary, acting through the Director of 
the Center.''.
    (b) Misbranding.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by inserting after subsection 
(j) the following:
    ``(k) If it is a drug or biological product for which the sponsor 
of an application or holder of an approved application or license has 
not complied with an order or requirement under section 507.''.
    (c) Report on Devices.--Not later than 6 months after the date of 
enactment of this Act, the Secretary of Health and Human Services, in 
consultation with the Commissioner of Food and Drugs, the Director of 
the Center for Postmarket Drug Evaluation and Research, and the 
Director of the Center for Devices and Radiological Health, shall 
submit to Congress a report that--
            (1) identifies deficiencies in the current process of 
        postmarket surveillance of devices approved under the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.);
            (2) includes recommendations on ways to improve 
        deficiencies of postmarket surveillance of devices; and
            (3) identifies the changes in authority needed to make 
        those improvements, recognizing the legitimate differences 
        between devices and other medical products regulated by the 
        Food and Drug Administration.
    (d) Transfer of Functions.--The functions and duties of the Office 
of Drug Safety, including the Drug Safety and Risk Management Drugs 
Advisory Committee, of the Food and Drug Administration on the day 
before the date of enactment of this Act shall be transferred to the 
Center for Postmarket Drug Evaluation and Research established under 
section 507 of the Federal Food, Drug, and Cosmetic Act (as added by 
this section). The Center for Postmarket Drug Evaluation and Research 
shall be a separate entity within the Food and Drug Administration and 
shall not be an administrative office of the Center for Drug Evaluation 
and Research or the Center for Biologics Evaluation and Research.
    (e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this Act (and the amendments made by this 
Act)--
            (1) $50,000,000 for fiscal year 2006;
            (2) $75,000,000 for fiscal year 2007;
            (3) $100,000,000 for fiscal year 2008;
            (4) $125,000,000 for fiscal year 2009; and
            (5) $150,000,000 for fiscal year 2010.
                                 <all>