[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1584 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                S. 1584

          To provide for additional quality control of drugs.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 20, 2011

  Mr. Bennet introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
          To provide for additional quality control of drugs.

    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 ``Drug Safety and Accountability Act 
of 2011''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) Recent manufacturing quality problems resulting in drug 
        recalls and warnings from the Food and Drug Administration have 
        exposed gaps in quality systems to ensure drugs in the United 
        States are safe and free from contamination.
            (2) Adherence to quality standards is the most effective 
        way to ensure drug quality and integrity. It is impossible to 
        test every pharmaceutical item that is produced.
            (3) More than 1,300,000 over-the-counter children's 
        medicines were recalled in 2010 for quality issues that 
        presented possible risk to patient health, and the quality 
        standards at many other over-the-counter manufacturers are 
        unknown.
            (4) Up to 149 Americans died in 2007 and 2008 after taking 
        heparin, a blood thinner, contaminated during the manufacturing 
        process in China.
            (5) Up to 80 percent of the active ingredients in drugs 
        used in the United States are made overseas, many in countries 
        where regulatory oversight does not meet the standards of the 
        United States.

SEC. 3. QUALITY CONTROL OF DRUGS.

    (a) Adulteration.--Section 501 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351) is amended by adding at the end the 
following:
    ``(j) If it is a drug that was manufactured, prepared, propagated, 
compounded, or processed by an establishment that is, or was at the 
time of such manufacture, preparation, propagation, compounding, or 
processing, in violation of subsection (q) or (r) of section 510.''.
    (b) Additional Requirements of Producers of Drugs.--Section 510 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended by 
adding at the end the following:
    ``(q) Quality Management Plans.--
            ``(1) Scope.--Each person required to register under 
        subsection (b), (c), (d), or (i), with respect to the 
        manufacture, preparation, propagation, compounding, or 
        processing of a drug shall have in effect and implement a 
        quality management plan to ensure the quality and safety of--
                    ``(A) each such drug, including when such drug is 
                prepared, propagated, compounded, or processed by 
                another person;
                    ``(B) each active and inactive ingredient of such 
                drug, including when such ingredient is prepared, 
                propagated, compounded, processed, or held by another 
                person; and
                    ``(C) materials used in the manufacture of the 
                active ingredient, based on a risk assessment that 
                gives additional consideration to materials extracted 
                or derived from plants, microbes, animal tissue, or 
                other biological sources.
            ``(2) Provisions.--
                    ``(A) In general.--Each quality management plan 
                required under paragraph (1) shall--
                            ``(i) address risk assessment, risk 
                        control, risk communication, and risk review;
                            ``(ii) provide for an assessment, prior to 
                        contracting with a person to supply ingredients 
                        or to undertake any aspect of the manufacturing 
                        of a drug, of the suitability and competence of 
                        such person to carry out such activity, using 
                        audits, material evaluations, or qualification, 
                        as appropriate;
                            ``(iii) define responsibilities and 
                        communication processes for manufacturing, 
                        quality control, and quality assurance 
                        activities of any person described in clause 
                        (ii);
                            ``(iv) provide for the monitoring and 
                        review through periodic on-site audits of the 
                        facility conditions, controls, and practices of 
                        any person described in clause (ii) and ensure 
                        the implementation of appropriate measures to 
                        improve such conditions, controls, and 
                        practices;
                            ``(v) provide for the monitoring of 
                        incoming materials to ensure that such 
                        materials are from a person who meets the 
                        requirements under clauses (ii) through (iv);
                            ``(vi) provide for implementation of 
                        effective systems, including appropriate 
                        specifications and test methods and 
                        verification of the identity, quality, 
                        strength, and purity of drug ingredients, to 
                        detect any hazard that has been, or is 
                        reasonably likely to be, present in or on the 
                        drug during production, manufacturing, 
                        processing, packing, holding, or transporting; 
                        and
                            ``(vii) provide for adequate assessment of 
                        materials used in the manufacture of the active 
                        ingredient.
                    ``(B) Additional provisions.--If the Secretary 
                determines that provisions in addition to those 
                described in subparagraph (A) would be appropriate to 
                include in quality risk management plans for the 
                protection of the public health, including provisions 
                for the prevention of intentional adulteration of a 
                drug or class of drugs, the Secretary may by regulation 
                require that such provisions be included in quality 
                risk management plans.
            ``(3)  Review and updating.--Each person required to 
        implement a quality management plan under this subsection shall 
        periodically review such plan and update such plan as 
        necessary.
            ``(4) Application of specifications or test methods by 
        order of the secretary.--If the Secretary finds that there is a 
        significant threat to public health, the Secretary may order an 
        establishment--
                    ``(A) to promptly revise its quality risk 
                management plan to include new or modified 
                specifications or test methods for a drug; and
                    ``(B) to promptly implement such specifications or 
                test methods.
            ``(5) Inspection of quality management plan.--The Secretary 
        shall, in the course of an inspection under section 704 of an 
        establishment subject to this subsection or upon request by the 
        Secretary, conduct a review of the quality management plan of 
        the establishment.
    ``(r) Documentation of Supply Chain.--Each person required to 
register under subsection (b), (c), (d), or (i), with respect to the 
manufacture, preparation, propagation, compounding, or processing of a 
drug shall provide, at the request of the Secretary, documentation of 
the names, addresses, phone numbers, and Global Positioning System 
coordinates of each producer, manufacturer, distributor, and shipper 
involved in the production of a drug or the production or transport of 
the active ingredients of a drug, and, where the assessment of 
materials described in subsection (q)(2)(A)(vii) is required, each 
producer, manufacturer, distributor, and shipper involved in the 
production or transport of such materials. Such documentation shall 
show that the drug and the ingredients of the drug were manufactured, 
prepared, propagated, compounded, processed, and handled in a manner 
ensuring the identity, safety, quality, purity, and strength of such 
drug.
    ``(s) Tracking Systems.--Not later than 1 year after the date of 
enactment of the Drug Safety and Accountability Act of 2011, the 
Secretary shall develop and maintain information systems to track and 
assess every establishment that is involved in the manufacturing, 
preparation, propagation, compounding, or processing of a drug or 
active ingredient of a drug. The Secretary shall ensure the 
interoperability of all databases relevant to the tracking and 
assessment of such establishments and include in each such database the 
D-U-N-S number of each such establishment required under subsection (b) 
to provide a D-U-N-S number.
    ``(t) Over-the-Counter Drugs.--In determining, for purposes of 
inspection, the risk associated with a person required to register 
under this section, the Secretary shall not consider whether the drugs 
manufactured, prepared, propagated, compounded, or processed by such 
person are drugs described in section 503(b).''.
    (c) Unique Registration Numbers.--Section 510 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (1), by striking ``and all such 
                establishments'' and inserting ``all such 
                establishments, and the D-U-N-S number of each such 
                establishment''; and
                    (B) in paragraph (2), by striking ``and all such 
                establishments'' and inserting ``all such 
                establishments, and the D-U-N-S number of each such 
                establishment'';
            (2) in subsection (c), by striking ``such establishment'' 
        and inserting ``such establishment, and the D-U-N-S number of 
        such establishment'';
            (3) in subsection (d), by inserting ``, and the D-U-N-S 
        number of such establishment'' after ``devices''; and
            (4) in subsection (i)(1)(A), by inserting ``the D-U-N-S 
        number of each such establishment,'' after ``place of business 
        of the establishment,''.
    (d) Factory Inspection.--Section 704(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended, in the first 
sentence, by inserting ``in the United States or for import into the 
United States,'' after ``to enter, at reasonable times, any factory, 
warehouse, or establishment in which food, drugs, devices, tobacco 
products, or cosmetics are manufactured, processed, packed, or held,''.
    (e) Mutual Recognition Agreement Progress Report.--The Secretary of 
Health and Human Services shall, not later than 1 year after the date 
of enactment of this Act, issue a report that describes the progress on 
implementing cooperative arrangements and mutual recognition agreements 
relating to the regulation of drugs and good manufacturing practices 
entered into under section 510(i)(3) or section 803 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)(3), 383).
    (f) Mandatory Recall Authority for Drugs.--
            (1) 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. MANDATORY RECALL AUTHORITY FOR DRUGS.

    ``(a) Order To Cease Distribution; Notification; Process.--
            ``(1) Order to cease distribution; notification.--If the 
        Secretary finds that there is a reasonable probability that a 
        drug intended for human use would cause serious, adverse health 
        consequences or death, the Secretary shall issue an order 
        requiring the appropriate person (including the manufacturers, 
        importers, distributors, or retailers of the drug)--
                    ``(A) to immediately cease distribution of such 
                drug; and
                    ``(B) to immediately notify health professionals 
                and hospitals and other health care facilities of the 
                order and to instruct such professionals and facilities 
                to cease use of such drug.
            ``(2) Process.--The order under paragraph (1) shall provide 
        the person subject to the order with an opportunity for an 
        informal hearing, to be held not later than 10 days after the 
        date of the issuance of the order, on the actions required by 
        the order and on whether the order should be amended to require 
        a recall of such drug. If, after providing an opportunity for 
        such a hearing, the Secretary determines that inadequate 
        grounds exist to support the actions required by the order, the 
        Secretary shall vacate the order.
    ``(b) Order To Recall.--
            ``(1) In general.--If, after providing an opportunity for 
        an informal hearing under subsection (a), the Secretary 
        determines that the order should be amended to include a recall 
        of the drug with respect to which the order was issued, the 
        Secretary shall, except as provided in paragraph (2), amend the 
        order to require a recall. The Secretary shall specify a 
        timetable in which the drug recall will occur and shall require 
        periodic reports to the Secretary describing the progress of 
        the recall.
            ``(2) Amended order.--An amended order under paragraph 
        (1)--
                    ``(A) shall--
                            ``(i) not include recall of a drug from 
                        individuals; and
                            ``(ii) not include recall of a drug from 
                        hospitals and other health care facilities if 
                        the Secretary determines that the risk of 
                        recalling such drug from the facilities 
                        presents a greater health risk than the health 
                        risk of not recalling the drug from use; and
                    ``(B) shall provide for notice to individuals 
                subject to the risks associated with the use of such 
                drug.
            ``(3) Assistance.--In providing the notice required by 
        paragraph (2), the Secretary may use the assistance of health 
        professionals who prescribed or used such a drug for 
        individuals. If a significant number of such individuals cannot 
        be identified, the Secretary shall notify such individuals 
        pursuant to section 705(b).''.
            (2) Regulations.--Until the date that the Secretary of 
        Health and Human Services issues a final regulation to 
        implement section 507 of the Federal Food, Drug, and Cosmetic 
        Act (as added by paragraph (1)), the regulations on medical 
        device recall authority in part 810 of title 21, Code of 
        Federal Regulations, shall apply to any recall of a drug under 
        such section 507.
            (3) Prohibited acts.--Section 301 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at 
        the end the following:
    ``(aaa) The failure to comply with an order issued under section 
507.''.
    (g) Subpoena Authority.--Section 702 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 372) is amended by adding at the end the 
following:
    ``(f)(1) The Secretary may conduct investigations as the Secretary 
deems necessary--
            ``(A) to carry out the authority of the Secretary under 
        this Act or section 351 of the Public Health Service Act; or
            ``(B) to determine whether any person has engaged or is 
        about to engage in any act that constitutes or will constitute 
        a violation of this Act or such section 351.
    ``(2) For the purpose of any investigation conducted under 
paragraph (1), the Secretary may administer oaths and affirmations, 
subpoena witnesses, compel the attendance of such witnesses, take 
evidence, and require the production of any books, papers, documents, 
or other materials that are relevant to the investigation.
    ``(3)(A) In case of contumacy or refusal to obey a subpoena issued 
under paragraph (2), the district court of the United States for the 
judicial district in which such investigation or proceeding is 
conducted, or in which the subpoenaed person resides or conducts 
business, may issue an order requiring such person to appear before the 
Secretary, testify, or produce books, papers, documents, or other 
materials that are relevant to the investigation. All process in any 
such case may be served in the judicial district in which such person 
resides or may be found.
    ``(B) Any failure to obey an order issued under subparagraph (A) 
may be punished by the court as contempt of court.''.
    (h) Civil Penalties.--
            (1) In general.--Section 303(f) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 333(f)) is amended--
                    (A) in paragraph (4), by striking ``or 505-1'' each 
                place it appears and inserting ``505-1, or 505A'';
                    (B) by adding at the end the following:
            ``(10)(A)(i) Any manufacturer, distributor, importer, 
        broker, or filer that violates a requirement of this Act that 
        relates to drugs for human use (except a requirement referred 
        to in paragraph (4) or subsection (g)) shall be liable to the 
        United States for a civil penalty not to exceed $100,000 per 
        violation.
            ``(ii) Each day during which a violation continues shall be 
        considered a separate violation under clause (i).
            ``(B)(i) Any manufacturer, distributor, importer, broker, 
        or filer that knowingly reports or enters false or misleading 
        data on documents related to the importation of a drug shall be 
        liable to the United States for a civil penalty not to exceed 
        $150,000.
            ``(ii) Each act of reporting or entering false data shall 
        be considered a separate violation under clause (i).''; and
                    (C) in paragraph (5) by striking ``, or (9)'' each 
                place it appears and inserting ``(9), or (10)''.
            (2) Applicability.--Section 303(f)(10) of the Federal Food, 
        Drug, and Cosmetic Act, as added by paragraph (1), shall apply 
        to violations described in such section that occur after the 
        date of enactment of this Act.
    (i) Exchange of Information.--
            (1) In general.--Section 708 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379) is amended--
                    (A) by striking ``The Secretary'' and inserting 
                ``(a) The Secretary''; and
                    (B) by adding at the end the following:
    ``(b)(1)(A) The Secretary may provide to any Federal agency acting 
within the scope of its jurisdiction any information relating to drugs 
that is exempt from disclosure pursuant to subsection (a) of section 
552 of title 5, United States Code, by reason of subsection (b)(4) of 
such section, or that is referred to in section 301(j).
    ``(B) Any such information provided to another Federal agency shall 
not be disclosed by such agency except in any action or proceeding 
under the laws of the United States to which the receiving agency or 
the United States is a party.
    ``(2)(A) In carrying out this Act, the Secretary may provide to a 
State or local government agency any information relating to drugs that 
is exempt from disclosure pursuant to section 552(a) of title 5, United 
States Code, by reason of subsection (b)(4) of such section, or that is 
referred to in section 301(j).
    ``(B) Any such information provided to a State or local government 
agency shall not be disclosed by such agency.
    ``(3) In carrying out this Act, the Secretary may provide to any 
person any information relating to drugs that is exempt from disclosure 
pursuant to section 552(a) of title 5, United States Code, by reason of 
subsection (b)(4) of such section, if the Secretary determines that 
providing the information to the person is appropriate under the 
circumstances and the recipient provides adequate assurances to the 
Secretary that the recipient will preserve the confidentiality of the 
information.
    ``(4) In carrying out this Act, the Secretary may provide any 
information relating to drugs that is exempt from disclosure pursuant 
to section 552(a) of title 5, United States Code, by reason of 
subsection (b)(4) of such section, or that is referred to in section 
301(j)--
            ``(A) to any foreign government agency; or
            ``(B) any international organization established by law, 
        treaty, or other governmental action and having 
        responsibility--
                    ``(i) to facilitate global or regional 
                harmonization of standards and requirements in an area 
                of responsibility of the Food and Drug Administration; 
                or
                    ``(ii) to promote and coordinate public health 
                efforts,
        if the agency or organization provides adequate assurances to 
        the Secretary that the agency or organization will preserve the 
        confidentiality of the information.
    ``(c) Except where specifically prohibited by statute, the 
Secretary may disclose to the public any information relating to drugs 
that is exempt from disclosure pursuant to section 552(a) of title 5, 
United States Code, by reason of subsection (b)(4) of such section, if 
the Secretary determines that such disclosure is necessary to protect 
the public health.
    ``(d) Except as provided in subsection (e), the Secretary shall not 
be required to disclose under section 552 of title 5, United States 
Code, or any other provision of law any information relating to drugs 
obtained from a Federal, State, or local government agency, or from a 
foreign government agency, or from an international organization 
described in subsection (b)(4), if the agency or organization has 
requested that the information be kept confidential, or has precluded 
such disclosure under other use limitations, as a condition of 
providing the information.
    ``(e) Nothing in subsection (d) authorizes the Secretary to 
withhold information from the Congress or prevents the Secretary from 
complying with an order of a court of the United States.
    ``(f) This section shall not affect the authority of the Secretary 
to provide or disclose information under any other provision of law.''.
            (2) Conforming amendment.--Section 301(j) (21 U.S.C. 
        331(j)) is amended by striking ``or to the courts when relevant 
        in any judicial proceeding under this Act,'' and inserting ``to 
        the courts when relevant in any judicial proceeding under this 
        Act, or as specified in section 708,''.
    (j) Whistleblower Protection.--Chapter X of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the 
end the following:

``SEC. 1013. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, OR WHO 
              DISCLOSE VIOLATIONS OF, THIS ACT OR SECTION 351 OF THE 
              PUBLIC HEALTH SERVICE ACT.

    ``(a) In General.--
            ``(1) Protections for employees.--No person that submits, 
        or is required to submit to the Secretary a submission 
        described in paragraph (2), or any officer, employee, 
        contractor, subcontractor, or agent of such a person, may 
        discharge, demote, suspend, threaten, harass, or in any other 
        manner discriminate against an employee in the terms and 
        conditions of employment because of any lawful act done by the 
        employee, including within the ordinary course of the job 
        duties of such employee--
                    ``(A) to provide information, cause information to 
                be provided, or otherwise assist in any investigation 
                regarding any conduct which the employee reasonably 
                believes constitutes a violation of any section of this 
                Act or the Public Health Service Act described under 
                paragraph (2), any other provision of Federal law 
                relating to the safety or effectiveness of a drug, 
                biological product, or device, or any provision of 
                Federal law prohibiting fraud against the Food and Drug 
                Administration, if the information or assistance is 
                provided to, or an investigation stemming from the 
                provided information is conducted by--
                            ``(i) a Federal regulatory or law 
                        enforcement agency;
                            ``(ii) any Member of Congress or any 
                        committee of Congress; or
                            ``(iii) a person with supervisory authority 
                        over the employee (or such other person working 
                        for the employer who has the authority to 
                        investigate, discover, or terminate the 
                        misconduct);
                    ``(B) to file, cause to be filed, testify, 
                participate in, or otherwise assist in a proceeding 
                filed or about to be filed (with any knowledge of the 
                employer) relating to an alleged violation of any 
                section of this Act or the Public Health Service Act 
                described under paragraph (2), any other provision of 
                Federal law relating to the safety or effectiveness of 
                a drug, biological product, or device, or any provision 
                of Federal law prohibiting fraud against the Food and 
                Drug Administration; or
                    ``(C) to refuse to violate or assist in the 
                violation of any section of this Act or the Public 
                Health Service Act listed described paragraph (2), any 
                other provision of Federal law relating to the safety 
                or effectiveness of a drug, biological product, or 
                device, or any provision of Federal law prohibiting 
                fraud against the Food and Drug Administration.
            ``(2) Submission.--A submission described in this paragraph 
        is--
                    ``(A) a new drug application under section 505(b);
                    ``(B) an abbreviated new drug application under 
                section 505(j);
                    ``(C) a biologics license application under section 
                351 of the Public Health Service Act;
                    ``(D) an application for an investigational new 
                drug exemption under section 505(i);
                    ``(E) a new animal drug application under section 
                512(b);
                    ``(F) an abbreviated new animal drug application 
                under section 512(b);
                    ``(G) an application under section 571;
                    ``(H) a request under section 572;
                    ``(I) an application or report for premarket 
                approval under section 515;
                    ``(J) an application for an investigational device 
                exemption under section 520(g);
                    ``(K) a report under section 510(k);
                    ``(L) an application for a humanitarian device 
                exemption under section 520(m);
                    ``(M) an amendment, supplement, or other submission 
                with respect to any such application or report 
                described in subparagraphs (A) through (L); or
                    ``(N) a record or report related to an adverse 
                event, a postapproval study, a postapproval clinical 
                trial, a report, or postmarket surveillance under 
                section 505(k), 505(o), 519, 522, or 760.
    ``(b) Enforcement Action.--
            ``(1) In general.--An employee who alleges discharge, or 
        other discrimination in violation of subsection (a), may seek 
        relief in accordance with the provisions of subsection (c), 
        by--
                    ``(A) filing a complaint with the Secretary of 
                Labor; or
                    ``(B) if the Secretary of Labor has not issued a 
                final decision within 210 days of 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.--Any action under paragraph (1) 
                shall be governed under the rules and procedures set 
                forth in section 42121(b) of title 49, United States 
                Code.
                    ``(B) Exception.--Notification in an action under 
                paragraph (1) shall be made in accordance with section 
                42121(b)(1) of title 49, United States Code, except 
                that such notification shall be made to the person 
                named in the complaint and to the 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 180 
                days after the date on which the violation occurs.
    ``(c) Remedies.--
            ``(1) In general.--An employee prevailing in any action 
        under subsection (b)(1) shall be entitled to all relief 
        necessary to make the employee whole.
            ``(2) Compensatory damages.--Relief in an action under 
        subsection (b) shall include--
                    ``(A) reinstatement with the same seniority status 
                that the employee would have had, but for the 
                discrimination;
                    ``(B) the amount of backpay owed to the employee, 
                with interest; and
                    ``(C) compensation for any special damages 
                sustained as a result of the discrimination, including 
                litigation costs, expert witness fees, and reasonable 
                attorney fees.
    ``(d) Rights Retained by Employee.--Nothing in this section shall 
be deemed to diminish the rights, privileges, or remedies of any 
employee 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.''.
                                 <all>