[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 882 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                 S. 882

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 
and quality of medical products and enhance the authorities of the Food 
            and Drug Administration, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 23, 2009

 Mr. Reid for (Mr. Kennedy (for himself and Mr. Grassley)) introduced 
the following bill; which was read twice and referred to the Committee 
               on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 
and quality of medical products and enhance the authorities of the Food 
            and Drug Administration, 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 ``Drug and Device Accountability Act 
of 2009''.

SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.

    (a) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.
TITLE I--ENSURING THE SAFETY AND QUALITY OF MEDICAL PRODUCTS AND THEIR 
                               COMPONENTS

  Subtitle A--Enhanced Registration and Inspection of Drug and Device 
                             Establishments

Sec. 101. Registration of drug and device establishments.
Sec. 102. Registration of foreign drug and device establishments.
Sec. 103. Registration of establishments for drug precursor 
                            ingredients.
Sec. 104. Registration and licensing of drug importers.
Sec. 105. Inspection of drug and device establishments.
Sec. 106. Listing of drugs and devices; enhanced information technology 
                            system for registration and listing; 
                            inactive ingredients.
Sec. 107. Fees related to establishment inspections.
Sec. 108. Electronic submission and certification of registrations and 
                            listings.
Sec. 109. Technical and conforming amendments.
Sec. 110. Effective date.
     Subtitle B--Ensuring Identity and Sourcing of Drug Ingredients

Sec. 111. Compendial modernization.
Sec. 112. Testing of drug purity and identity.
Sec. 113. Manufacturer responsibility for source and quality of drug 
                            ingredients.
Sec. 114. Current manufacturing science.
Sec. 115. Country of origin labeling.
Sec. 116. Effective date; implementation.
           Subtitle C--Ensuring Standards for Imported Drugs

Sec. 121. Good distribution and import practices.
Sec. 122. Standards for admission of imported drugs and drug 
                            ingredients.
Sec. 123. Prohibition on use of drugs and drug ingredients not declared 
                            as drugs on importation.
Sec. 124. Destruction of unsafe products refused admission.
Sec. 125. Effective date.
             Subtitle D--Enhanced Response to Unsafe Drugs

Sec. 131. Administrative detention of drugs.
Sec. 132. Mandatory recall authority for drugs.
Sec. 133. Records and reports of drug defects and destruction of 
                            defective drugs that cannot be 
                            reconditioned.
Sec. 134. Civil money penalties.
     Subtitle E--Additional Provisions Related to Medical Products

Sec. 141. Certification of information.
Sec. 142. Whistleblower protections.
Sec. 143. Study by the Institute of Medicine regarding the review of 
                            medical devices.
 TITLE II--GENERAL AUTHORITIES TO ENHANCE FOOD AND DRUG ADMINISTRATION 
               OVERSIGHT OF PRODUCTS FROM A GLOBAL MARKET

Sec. 201. Dedicated foreign inspectorate.
Sec. 202. Authority to exchange confidential information with foreign 
                            government officials.
Sec. 203. Subpoena authority.
Sec. 204. Information reporting.
    (b) References in Act.--Except as otherwise specified, amendments 
made by this Act to a section or other provision of law are amendments 
to such section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).

TITLE I--ENSURING THE SAFETY AND QUALITY OF MEDICAL PRODUCTS AND THEIR 
                               COMPONENTS

  Subtitle A--Enhanced Registration and Inspection of Drug and Device 
                             Establishments

SEC. 101. REGISTRATION OF DRUG AND DEVICE ESTABLISHMENTS.

    Section 510 (21 U.S.C. 360) is amended--
            (1) by striking subsection (b) and inserting the following:
    ``(b) Registration of Domestic Establishments.--Any person who owns 
or operates any establishment in any State engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug or 
device shall--
            ``(1) upon first engaging in any such activity, immediately 
        submit a registration to the Secretary that includes the name 
        of such person, places of business of such person, all such 
        establishments, the D-U-N-S number of each such establishment, 
        an e-mail address for use in an emergency, and payment of any 
        inspection fee for each such establishment required under 
        section 743;
            ``(2) thereafter immediately submit a registration that 
        includes the information and fee described in paragraph (1) for 
        any additional establishment owned or operated by such person 
        in any State in which such person begins the manufacture, 
        preparation, propagation, compounding, or processing of a drug 
        or device; and
            ``(3) thereafter--
                    ``(A) with respect to such drugs, submit a 
                registration described in paragraph (1) to the 
                Secretary on or before December 31 of each year; and
                    ``(B) with respect to such devices, submit a 
                registration described in paragraph (1) to the 
                Secretary during the period beginning on October 1 and 
                ending on December 31 of each year.''; and
            (2) by striking subsections (c) and (d).

SEC. 102. REGISTRATION OF FOREIGN DRUG AND DEVICE ESTABLISHMENTS.

    (a) Enforcement of Registration of Foreign Establishments.--Section 
502(o) (21 U.S.C. 352(o)) is amended by striking ``in any State''.
    (b) Registration of Foreign Establishments.--Section 510 (U.S.C. 
360), as amended by section 101, is further amended--
            (1) by transferring subsection (i) so as to appear after 
        subsection (b); and
            (2) in subsection (i) (as so transferred)--
                    (A) by striking ``(i) (1)'' and all that follows 
                through ``of each year.'' and inserting the following:
    ``(c) Registration of Foreign Establishments.--
            ``(1) In general.--Any person who owns or operates any 
        establishment within any foreign country engaged in the 
        manufacture, preparation, propagation, compounding, or 
        processing of a drug or device that is imported or offered for 
        import into the United States shall--
                    ``(A) upon first engaging in any such activity, 
                immediately submit a registration to the Secretary that 
                includes the name and place of business of such person, 
                all such establishments, the D-U-N-S number of each 
                such establishment, an e-mail address for use in an 
                emergency, payment of any inspection fee for each such 
                establishment required under section 743, the name of 
                the United States agent of each such establishment, the 
                name of each importer of such drug or device in the 
                United States that is known to each such establishment, 
                and the name of each person who imports or offers for 
                import such drug or device to the United States for 
                purposes of importation;
                    ``(B) thereafter immediately submit a registration 
                that includes the information and fee described in 
                paragraph (1) for any additional establishment owned or 
                operated by such person within any foreign country in 
                which such person begins the manufacture, preparation, 
                propagation, compounding, or processing of such a drug 
                or device; and
                    ``(C) thereafter--
                            ``(i) with respect to drugs, submit a 
                        registration described in subparagraph (A) to 
                        the Secretary on or before December 31 of each 
                        year; and
                            ``(ii) with respect to devices, submit a 
                        registration described in subparagraph (A) to 
                        the Secretary during the period beginning on 
                        October 1 and ending on December 31 of each 
                        year.'';
                    (B) by striking paragraph (2);
                    (C) in paragraph (3), by striking ``(3) The 
                Secretary'' and inserting ``(2) Cooperative 
                arrangements.--The Secretary''; and
                    (D) by moving the indentation of paragraph (2), as 
                amended, 2 ems to the right.

SEC. 103. REGISTRATION OF ESTABLISHMENTS FOR DRUG PRECURSOR 
              INGREDIENTS.

    (a) Registration of Establishments That Manufacture Drug Precursor 
Ingredients.--Section 510(a) (21 U.S.C. 360(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking ``As 
        used'' and inserting ``Definitions.--As used'';
            (2) by redesignating paragraphs (1) and (2) as paragraphs 
        (2) and (3), respectively; and
            (3) by inserting after ``this section--'' the following:
            ``(1) the term `drug' includes a precursor ingredient;''.
    (b) Definition of Precursor Ingredient.--Section 201 (21 U.S.C. 
321) is amended by adding at the end the following:
    ``(rr) The term `precursor ingredient', with respect to an active 
ingredient of a drug, means an article that is a material--
            ``(1) of animal origin from which such active ingredient is 
        derived; or
            ``(2) used in the final stage of synthesis or purification 
        of such active ingredient, if so specified by the Secretary by 
        regulation or in an order approving a drug that bears or 
        contains such active ingredient.''.

SEC. 104. REGISTRATION AND LICENSING OF DRUG IMPORTERS.

    Section 510 (21 U.S.C. 360), as amended by section 102, is further 
amended by inserting after subsection (c) the following:
    ``(d) Registration and Licensing of Drug Importers.--
            ``(1) In general.--Any person who owns or operates any 
        establishment engaged in the importation, filing for 
        importation, or brokering for importation of a drug into the 
        United States shall--
                    ``(A) upon first engaging in any such activity, 
                immediately submit a registration to the Secretary that 
                includes the name of such person, places of business of 
                such person, all such establishments, the D-U-N-S 
                number of each such establishment, and an e-mail 
                address for use in an emergency;
                    ``(B) thereafter immediately submit a registration 
                that includes the information described in subparagraph 
                (A) for any additional establishment owned or operated 
                by such person in which such person begins any such 
                activity; and
                    ``(C) thereafter submit a registration described in 
                subparagraph (A) to the Secretary during the period 
                beginning on October 1 and ending on December 31 of 
                each year.
            ``(2) Licensing.--
                    ``(A) In general.--The Secretary may require any 
                person engaged in the importation, filing for 
                importation, or brokering for importation of a drug 
                into the United States, before engaging in those 
                activities, to obtain a license to be issued by the 
                Secretary.
                    ``(B) Bond.--The Secretary may require as a 
                condition of a license for a person under subparagraph 
                (A) that the person post a bond subject to forfeiture 
                if the person has, in connection with the importation, 
                filing for importation, or brokering for importation of 
                a drug into the United States--
                            ``(i) violated, or caused the violation, of 
                        this Act; or
                            ``(ii) made, or caused to be made, a false 
                        or misleading statement.
                    ``(C) Amount of bond.--The Secretary shall ensure 
                that the amount of any bond required under subparagraph 
                (B) for a person is sufficient to deter such person 
                from, in connection with the importation, filing for 
                importation, or brokering for importation of a drug 
                into the United States--
                            ``(i) violating, or causing the violation 
                        of, this Act; or
                            ``(ii) making, or causing to be made, a 
                        false or misleading statement.
                    ``(D) Revocation.--The Secretary may revoke the 
                license for a person under subparagraph (A) if the 
                Secretary finds that, in connection with the 
                importation, filing for importation, or brokering for 
                importation of a drug into the United States, such 
                person has--
                            ``(i) violated, or caused the violation of, 
                        this Act; or
                            ``(ii) made, or caused to be made, a false 
                        or misleading statement.''.

SEC. 105. INSPECTION OF DRUG AND DEVICE ESTABLISHMENTS.

    (a) Equal Inspection Authority for Domestic and Foreign 
Establishments; Refused Inspections.--Section 510(h) (21 U.S.C. 360(h)) 
is amended by--
            (1) striking ``Every'' and inserting: ``Inspections.--
            ``(1) In general.--Every'';
            (2) striking ``in any State''; and
            (3) striking ``704 and every such establishment'' and 
        inserting ``704.
            ``(2) Refused inspection.--Any establishment described in 
        paragraph (1) shall not be considered duly registered under 
        this section if an inspection of such establishment by the 
        Secretary is refused, delayed, or limited by--
                    ``(A) the person who owns or operates such 
                establishment, or any agent or employee of such person; 
                or
                    ``(B) any agent of a governmental authority in the 
                foreign country within which such establishment is 
                located.
            ``(3) Biennial inspection schedule.--Except as provided in 
        paragraph (4), and except for establishments that manufacture, 
        prepare, propagate, compound, or process only inactive 
        ingredients, every establishment described in paragraph (1).''.
    (b) Providing for Risk-Based Inspections of Establishments.--
            (1) In general.--Section 510(h) (21 U.S.C. 360(h)), as 
        amended by subsection (a), is further amended by adding at the 
        end the following:
            ``(4) Risk-based inspection schedule.--
                    ``(A) In general.--The Secretary may by regulation 
                provide for an inspection schedule for establishments 
                described in paragraph (3) (including those 
                establishments that manufacture, prepare, propagate, 
                compound, or process only inactive ingredients) 
                different from that required by such paragraph.
                    ``(B) Inspection frequency and risk-based 
                factors.--In providing for an inspection schedule under 
                subparagraph (A), the Secretary--
                            ``(i) may require inspections of an 
                        establishment more frequently than once in 
                        every successive 2-year period;
                            ``(ii) shall require inspections of an 
                        establishment at least once in every successive 
                        5-year period; and
                            ``(iii) shall consider--
                                    ``(I) the risks presented by the 
                                drug or drugs, or the device or 
                                devices, manufactured, prepared, 
                                propagated, compounded, or processed by 
                                an establishment (including whether the 
                                drug is a finished dosage form, an 
                                active ingredient, a precursor 
                                ingredient, or an inactive ingredient; 
                                the route of administration of the 
                                drug; whether the device is intended to 
                                be implanted, permanently implantable, 
                                life sustaining, or life supporting; 
                                and the use or uses for which the drug 
                                or device is approved or cleared under 
                                this Act or licensed under section 351 
                                of the Public Health Service Act);
                                    ``(II) whether or not an 
                                establishment is within a foreign 
                                country with a governmental authority 
                                responsible for drugs or devices, as 
                                applicable, deemed adequate by the 
                                Secretary;
                                    ``(III) whether or not, and the 
                                frequency with which, an establishment 
                                is subject to inspection by a 
                                governmental authority responsible for 
                                drugs or devices, as applicable, deemed 
                                adequate by the Secretary; and
                                    ``(IV) such other factors as the 
                                Secretary determines are relevant to 
                                determining an inspection schedule for 
                                establishments.
                    ``(C) Risk-based factors for modifying frequency of 
                inspections of an establishment.--The Secretary may 
                inspect an establishment at a frequency different than 
                that required by the inspection schedule under 
                subparagraph (A) by considering--
                            ``(i) the history of any safety problems 
                        with any drug or device manufactured, prepared, 
                        propagated, compounded, or processed by the 
                        establishment;
                            ``(ii) the record of inspections by the 
                        Secretary of the establishment;
                            ``(iii) with respect to a drug that is not 
                        a finished dosage form, the record of 
                        inspections by a governmental authority 
                        responsible for drugs deemed adequate by the 
                        Secretary;
                            ``(iv) with respect to a drug that is an 
                        inactive ingredient, a quality certification by 
                        a private entity, if the Secretary has agreed 
                        to accept such a certification; and
                            ``(v) such other factors as the Secretary 
                        determines are relevant to assessing the risk 
                        presented by the drug or drugs, or the device 
                        or devices, manufactured, prepared, propagated, 
                        compounded, or processed by the 
                        establishment.''.
            (2) Implementation.--The Secretary of Health and Human 
        Services may issue a proposed rule to provide for a risk-based 
        inspection schedule as described in section 510(h)(4) of the 
        Federal Food, Drug, and Cosmetic Act, as amended by this Act, 
        no earlier than March 31, 2011.
    (c) Annual Report on Inspections of Establishments.--Section 510(h) 
(21 U.S.C. 360(h)), as amended by subsection (b), is further amended by 
adding at the end the following:
            ``(5) Annual report on inspections of establishments.--Not 
        later than February 1 of each year, the Secretary shall submit 
        a report to the Congress about--
                    ``(A) the appropriations used to inspect 
                establishments registered pursuant to this section in 
                the previous fiscal year;
                    ``(B) the number of domestic and foreign 
                establishments registered with the Secretary under this 
                section during the previous calendar year;
                    ``(C)(i) the number of domestic and foreign 
                establishments registered pursuant to this section that 
                the Secretary inspected in the previous fiscal year; 
                and
                    ``(ii) if the Secretary has provided for a schedule 
                under paragraph (4)(A) with different frequencies of 
                inspection for different classes of establishments, the 
                numbers and identities for each such class;
                    ``(D)(i) the number of domestic and foreign 
                establishments registered pursuant to this section that 
                the Secretary did not inspect in the previous fiscal 
                year; and
                    ``(ii) if the Secretary has provided for a schedule 
                under paragraph (4)(A) with expected frequencies of 
                inspection for different classes of establishments, the 
                numbers for each such class;
                    ``(E) information on the performance in the 
                previous fiscal year of the foreign inspectorate 
                established under section 704(h) including--
                            ``(i) the number of inspections conducted 
                        with and without personnel who are fluent in 
                        the language used in the establishment under 
                        inspection;
                            ``(ii) the number of personnel in such 
                        inspectorate;
                            ``(iii) the countries in which such 
                        personnel conduct inspections;
                            ``(iv) the offices in foreign countries 
                        where such personnel are permanently stationed;
                            ``(v) the number of personnel conducting 
                        inspections in each country who are fluent in 
                        the language or languages used in the 
                        establishments of that country; and
                            ``(vi) the number of personnel who are 
                        permanently stationed in each in-country office 
                        who are fluent in the language or languages 
                        used in the establishments of that country; and
                    ``(F) other information deemed relevant by the 
                Secretary.
            ``(6) Public availability of annual reports.--The Secretary 
        shall make the report required under paragraph (5) available to 
        the public on the Internet Web site of the Food and Drug 
        Administration.''.

SEC. 106. LISTING OF DRUGS AND DEVICES; ENHANCED INFORMATION TECHNOLOGY 
              SYSTEM FOR REGISTRATION AND LISTING; INACTIVE 
              INGREDIENTS.

    (a) Listing of Drugs and Devices.--Section 510(j) (21 U.S.C. 
360(j)) is amended--
            (1) by striking ``(j)(1) Every person who registers with 
        the Secretary under subsection (b), (c), (d), or (i)'' and 
        inserting the following:
    ``(i) Submission of List of Drugs and Devices.--
            ``(1) In general.--Every person who registers with the 
        Secretary under subsection (b) or (c)'';
            (2) in paragraph (1)--
                    (A) in subparagraph (B)(i), by inserting ``in the 
                case of a drug, the authority under this Act that does 
                not require such drug to be subject to section 505 and 
                section 512,'' after ``labeling for such drug or 
                device,'';
                    (B) in subparagraph (B)(ii), by inserting ``, in 
                the case of a drug, the authority under this Act that 
                does not require such drug to be subject to section 505 
                and section 512,'' after ``insert for such drug or 
                device'';
                    (C) by moving the indentation of subparagraphs (A) 
                through (D) 2 ems to the right; and
                    (D) in subparagraph (B), by moving the indentation 
                of clauses (i) and (ii) 2 ems to the right;
            (3) in paragraph (2)--
                    (A) by striking ``(2) Each person who registers 
                with the Secretary under this section'' and inserting 
                the following:
            ``(2) Report to secretary.--Every person who registers with 
        the Secretary under subsection (b) or (c)''; and
                    (B) by moving the indentation of subparagraphs (A) 
                through (D) 2 ems to the right;
            (4) in paragraph (3), by striking ``(3) The Secretary'' and 
        inserting the following:
            ``(3) Additional list.--The Secretary''; and
            (5) by adding at the end the following:
            ``(4) Submission for finished dosage form.--Every person 
        who files a list under paragraph (1) or reports a list under 
        paragraph (2) shall submit with such list, for any drug that is 
        a finished dosage form, the identity of each establishment 
        engaged in the manufacture, preparation, propagation, 
        compounding, or processing of--
                    ``(A) the finished dosage form;
                    ``(B) any active ingredient of the drug;
                    ``(C) any inactive ingredient of the drug; or
                    ``(D) any precursor ingredient of any such active 
                ingredient.''.
    (b) Enhanced Information Technology System for Registration and 
Listing.--Section 510(j) (21 U.S.C. 360(j)), as amended by subsection 
(a), is further amended by adding at the end the following:
            ``(5) Electronic submission and maintenance of 
        information.--Not later than October 1, 2010, the Secretary 
        shall establish and maintain--
                    ``(A) an Internet-based portal through which 
                information to register establishments under subsection 
                (b), (c), and (d) and to list drugs and devices under 
                this subsection shall be submitted to the Secretary; 
                and
                    ``(B) an electronic database (which shall not be 
                subject to inspection under subsection (f)) populated 
                with the information submitted under subparagraph (A) 
                that--
                            ``(i) includes appropriate links between 
                        registered establishments and between such 
                        establishments and listed drugs and devices 
                        sufficient to enable the Secretary to track and 
                        assess the establishments and articles involved 
                        in the manufacture, preparation, propagation, 
                        compounding, or processing of each drug that is 
                        a finished dosage form or an active ingredient 
                        and each device;
                            ``(ii) includes the date of each inspection 
                        by the Secretary (with the Secretary's report 
                        on and assessment of the inspection) for each 
                        such establishment and such other information 
                        on the inspectional record and compliance 
                        history of the establishment as the Secretary 
                        deems necessary and appropriate to assess the 
                        compliance history of the establishment and, if 
                        applicable, apply the inspection schedule under 
                        subsection (h)(4) to such establishment; and
                            ``(iii) is interoperable and communicates 
                        with other relevant databases within the Food 
                        and Drug Administration (including a database 
                        for submission of information under section 
                        801(p)).''.
    (c) Drugs That Are Not Approved Under Section 505 or 512.--Section 
510(f) (21 U.S.C. 360(f)) is amended--
            (1) by striking ``(f) The Secretary'' and inserting the 
        following:
    ``(f) Inspection by Public of Registration.--
            ``(1) In general.--The Secretary'';
            (2) by striking ``subsection (j)'' and inserting 
        ``subsection (i)''; and
            (3) by inserting at the end the following:
            ``(2) List of drugs that are not approved under section 505 
        or 512.--The Secretary shall make available to the public on 
        the Internet Web site of the Food and Drug Administration a 
        list that includes, for each drug described in subsection 
        (i)(1)(B)--
                    ``(A) the drug;
                    ``(B) the person who listed such drug; and
                    ``(C) the authority under this Act that does not 
                require such drug to be subject to section 505 and 
                section 512, as provided by such person in such 
                list.''.
    (d) Inactive Ingredients.--
            (1) Assessment of establishments that manufacture drug 
        inactive ingredients.--Not later than March 31, 2011, the 
        Secretary of Health and Human Services (referred to in this 
        subsection as the ``Secretary'') shall--
                    (A) use the information populating the electronic 
                database referred to in section 510(j)(5) of the 
                Federal, Food, Drug, and Cosmetic Act, as added by 
                subsection (b), to identify the establishments that 
                manufacture, prepare, propagate, compound, or process 
                an active ingredient of any drug listed in such 
                database; and
                    (B) complete an assessment as to whether the 
                exemption from registration in subsection (e) of 
                section 207.10 of title 21, Code of Federal 
                Regulations, should be eliminated or modified.
            (2) Regulation to eliminate or modify the exemption from 
        registration for establishments that manufacture drug inactive 
        ingredients.--In the regulation provided for under section 
        105(b)(2), the Secretary may propose to eliminate or modify the 
        exemption referred to in paragraph (1)(B), as the Secretary 
        deems appropriate, after having completed the assessment under 
        such paragraph.

SEC. 107. FEES RELATED TO ESTABLISHMENT INSPECTIONS.

    Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by 
adding at the end the following:

          ``PART 6--FEES RELATED TO ESTABLISHMENT INSPECTIONS

``SEC. 743. AUTHORITY TO ASSESS AND USE FEES.

    ``(a) Definitions.--In this section:
            ``(1) Affiliate.--The term `affiliate' means a business 
        entity that has a relationship with a second business entity 
        if, directly or indirectly--
                    ``(A) one business entity controls, or has the 
                power to control, the other business entity; or
                    ``(B) a third business entity controls, or has the 
                power to control, both of the business entities.
            ``(2) Device establishment.--The term `device 
        establishment' means--
                    ``(A) an establishment in any State that is--
                            ``(i) engaged in the manufacture, 
                        preparation, propagation, compounding, or 
                        processing of a device classified in class II 
                        or class III; and
                            ``(ii) subject to inspection under 
                        subsection (h)(3) or (h)(4) of section 510, as 
                        applicable; or
                    ``(B) an establishment within any foreign country 
                that is--
                            ``(i) engaged in the manufacture, 
                        preparation, propagation, compounding, or 
                        processing of a device classified in class II 
                        or class III that is imported or offered for 
                        import into the United States; and
                            ``(ii) subject to inspection under 
                        subsection (h)(3) or (h)(4) of section 510, as 
                        applicable.
            ``(3) Device registration and inspection activities.--The 
        term `device registration and inspection activities' means the 
        following activities of the Secretary:
                    ``(A) The registration of device establishments 
                under subsections (b) and (c) of section 510.
                    ``(B) The listing of devices under section 510(i), 
                including the activities for devices described in 
                section 510(i)(5).
                    ``(C) The inspection of device establishments under 
                section 510(h)(3) or, if applicable, section 510(h)(4).
                    ``(D) The review of inspection reports from such 
                inspections.
                    ``(E) Any action under this Act pursuant to such 
                registration, listing, inspections, or reviews.
            ``(4) Drug establishment.--The term `drug establishment' 
        means--
                    ``(A) an establishment in any State that is--
                            ``(i) engaged in the manufacture, 
                        preparation, propagation, compounding, or 
                        processing of a drug; and
                            ``(ii) subject to inspection under 
                        subsection (h)(3) or (h)(4) of section 510, as 
                        applicable; or
                    ``(B) an establishment within any foreign country 
                that is--
                            ``(i) engaged in the manufacture, 
                        preparation, propagation, compounding, or 
                        processing of a drug; and
                            ``(ii) subject to inspection under 
                        subsection (h)(3) or (h)(4) of section 510, as 
                        applicable.
            ``(5) Drug registration and inspection activities.--The 
        term `drug registration and inspection activities' means the 
        following activities of the Secretary:
                    ``(A) The registration of drug establishments under 
                subsections (b) and (c) of section 510.
                    ``(B) The listing of drugs under section 510(i), 
                including the activities for drugs described in section 
                510(i)(5).
                    ``(C) The inspection of drug establishments under 
                section 510(h)(3) or, if applicable, section 510(h)(4).
                    ``(D) The review of inspection reports from such 
                inspections.
                    ``(E) Any action under this Act pursuant to such 
                registration, listing, inspections, or reviews.
            ``(6) Person.--The term `person' includes an affiliate 
        thereof.
    ``(b) Types of Fees.--
            ``(1) Drug inspection fees.--Beginning in fiscal year 2010, 
        the Secretary shall collect drug inspection fees in accordance 
        with this section as follows:
                    ``(A) In general.--Except as provided under 
                subparagraphs (B), (C), and (D), each person that 
                during a fiscal year registers a drug establishment 
                under subsection (b) or (c) of section 510 shall be 
                subject to a drug inspection fee established under 
                subsection (c)(1).
                    ``(B) Reduction for positron emission tomography 
                drugs.--The drug inspection fee for a drug 
                establishment engaged solely in the manufacture, 
                preparation, propagation, compounding, or processing of 
                1 or more drugs to which section 736(a)(2)(C)(i) 
                applies shall be one-sixth of the drug inspection fee 
                otherwise applicable to such establishment under 
                subsection (c)(1).
                    ``(C) Exemption for certain positron emission 
                tomography drugs and certain orphan drugs.--A drug 
                establishment engaged solely in the manufacture, 
                preparation, propagation, compounding, or processing of 
                1 or more drugs to which section 736(a)(2)(C)(ii) or 
                section 736(k) applies shall not be assessed a drug 
                inspection fee.
                    ``(D) Waiver or reduction.--The Secretary shall 
                grant a waiver from or reduction of the drug inspection 
                fee as provided for under section 736(d).
            ``(2) Device inspection fees.--Beginning in fiscal year 
        2010, the Secretary shall collect device inspection fees in 
        accordance with this section as follows:
                    ``(A) In general.--Except as provided under 
                subparagraphs (B) and (C), each person that during a 
                fiscal year registers a device establishment under 
                subsection (b) or (c) of section 510 shall pay a device 
                inspection fee established under subsection (c)(2).
                    ``(B) Reduction for small businesses.--The device 
                inspection fee for a device establishment owned or 
                operated by an entity that qualifies as a small 
                business under section 738(d)(2) shall be one-fourth of 
                the device inspection fee otherwise applicable to such 
                establishment under subsection (c)(2).
                    ``(C) Exemption for certain state or federal 
                government establishments.--A device establishment 
                operated by a State or Federal Government entity shall 
                not be assessed a device inspection fee unless a device 
                classified in class II or class III manufactured by the 
                establishment is to be distributed commercially.
    ``(c) Fee Amounts.--
            ``(1) Drug inspection fee amounts.--
                    ``(A) In general.--Beginning with fiscal year 2010, 
                the Secretary shall, not later than 30 days after the 
                amount has been appropriated for a fiscal year in an 
                appropriations Act as described in subsection (e)(1), 
                establish for such fiscal year, and publish in the 
                Federal Register, drug inspection fees, based on the 
                amount provided for in advance in appropriations Acts 
                for such fees as described in subsection (e)(1), 
                considering--
                            ``(i) the requirement described under 
                        subparagraph (C);
                            ``(ii) the reductions required under 
                        subparagraphs (B) and (D) of subsection (b)(1); 
                        and
                            ``(iii) the number of drug establishments 
                        subject to such a fee, considering 
                        subparagraphs (C) and (D) of subsection (b)(1).
                    ``(B) Foreign drug establishment.--For a foreign 
                drug establishment, the drug inspection fee shall be--
                            ``(i) the applicable drug inspection fee 
                        under subparagraph (A), plus
                            ``(ii) the pro rata costs, if any, of--
                                    ``(I) travel to and within, and 
                                lodging in, the country in which the 
                                establishment is located for the 
                                individual or individuals who conduct 
                                the inspection of the establishment; 
                                and
                                    ``(II) a translator for the 
                                inspection of the establishment.
                    ``(C) Proportional fees.--
                            ``(i) Inspections more frequent than every 
                        2 years.--The drug inspection fee for a drug 
                        establishment that under the inspection 
                        schedule provided for under section 510(h)(4) 
                        is to be inspected more frequently than once in 
                        every 2-year period shall be more than the drug 
                        inspection fee for a drug establishment that 
                        under such schedule is to be inspected once in 
                        every 2-year period, in proportion to the 
                        factor by which such drug establishment to be 
                        is inspected more frequently than once in every 
                        2-year period.
                            ``(ii) Inspections less frequent than every 
                        2 years.--The drug inspection fee for a drug 
                        establishment that under the inspection 
                        schedule provided for under section 510(h)(4) 
                        is to be inspected less frequently than once in 
                        every 2-year period shall be less than the drug 
                        inspection fee for a drug establishment that 
                        under such schedule is to be inspected once in 
                        every 2-year period, in proportion to the 
                        factor by which such establishment is to be 
                        inspected less frequently than once in every 2-
                        year period.
            ``(2) Device inspection fee amounts.--
                    ``(A) In general.--Beginning with fiscal year 2010, 
                the Secretary shall, not later than 30 days after the 
                amount has been appropriated for a fiscal year in an 
                appropriations Act as described in subsection (e)(2) 
                establish for such fiscal year, and publish in the 
                Federal Register device inspection fees, based on the 
                amount provided for in advance in appropriations Acts 
                for such fees as described in subsection (e)(2) and 
                considering--
                            ``(i) the requirement described under 
                        subparagraph (C);
                            ``(ii) the reduction required under 
                        subsection (b)(2)(B); and
                            ``(iii) the number of device establishments 
                        subject to such a fee, considering subsection 
                        (b)(2)(C).
                    ``(B) Foreign device establishment.--For a foreign 
                device establishment, the device inspection fee shall 
                be--
                            ``(i) the applicable device inspection fee 
                        under subparagraph (A), plus
                            ``(ii) the pro rata costs, if any, of--
                                    ``(I) travel to and within, and 
                                lodging in, the country in which the 
                                establishment is located for the 
                                individual or individuals who conduct 
                                the inspection of the establishment; 
                                and
                                    ``(II) a translator for the 
                                inspection of the establishment.
                    ``(C) Proportional fees.--
                            ``(i) Inspections more frequent than every 
                        2 years.--The device inspection fee for a 
                        device establishment that under the inspection 
                        schedule provided for under section 510(h)(4) 
                        is to be inspected more frequently than once in 
                        every 2-year period shall be more than the 
                        device inspection fee for a device 
                        establishment that under such schedule is to be 
                        inspected once in every 2-year period, in 
                        proportion to the factor by which such device 
                        establishment is to be inspected more 
                        frequently than once in every 2-year period.
                            ``(ii) Inspections less frequent than every 
                        2 years.--The device inspection fee for a 
                        device establishment that under the inspection 
                        schedule provided for under section 510(h)(4) 
                        is to be inspected less frequently than once in 
                        every 2-year period shall be less than the 
                        device inspection fee for a device 
                        establishment that under such schedule is to be 
                        inspected once in every 2-year period, in 
                        proportion to the factor by which such 
                        establishment is to be inspected less 
                        frequently than once in every 2-year period.
    ``(d) Effect of Failure To Pay Fees.--
            ``(1) Drug inspection fee.--An establishment subject to a 
        drug inspection fee under subsection (b) shall be considered 
        not to be registered under section 510 until all fees under 
        this section owed by the person required to register such 
        establishment have been paid.
            ``(2) Device inspection fee.--An establishment subject to a 
        device inspection fee under subsection (b) shall be considered 
        not to be registered under section 510 until all fees under 
        this section owed by the person required to register such 
        establishment have been paid.
    ``(e) Crediting and Availability of Fees.--
            ``(1) Drug inspection fees.--Drug inspection fees 
        authorized under subsection (b) shall be collected and 
        available for obligation only to the extent and in the amount 
        provided in advance in appropriations Acts. Such fees are 
        authorized to remain available until expended. Such sums as may 
        be necessary may be transferred from the Food and Drug 
        Administration salaries and expenses appropriation account 
        without fiscal year limitation to such appropriation account 
        for salaries and expenses with such fiscal year limitation. The 
        sums transferred shall be available solely for drug 
        registration and inspection activities.
            ``(2) Device inspection fees.--Device inspection fees 
        authorized under subsection (b) shall be collected and 
        available for obligation only to the extent and in the amount 
        provided in advance in appropriations Acts. Such fees are 
        authorized to remain available until expended. Such sums as may 
        be necessary may be transferred from the Food and Drug 
        Administration salaries and expenses appropriation account 
        without fiscal year limitation to such appropriation account 
        for salaries and expenses with such fiscal year limitation. The 
        sums transferred shall be available solely for device 
        registration and inspection activities.
            ``(3) Authorization of appropriations.--
                    ``(A) Drug inspection fees.--Beginning in fiscal 
                year 2010, there is authorized to be appropriated for 
                each fiscal year for drug inspection fees under this 
                section such sums as may be necessary to carry out drug 
                inspection activities for such fiscal year, except that 
                such sums may be no greater than the lesser of--
                            ``(i) the amount appropriated (excluding 
                        fees) for such activities for such fiscal year; 
                        or
                            ``(ii) the difference between the amount 
                        necessary to carry out such activities for such 
                        fiscal year (as provided in the report required 
                        by subsection (h)(2)(A)) and the amount 
                        appropriated (excluding fees) for such 
                        activities for such fiscal year.
                    ``(B) Device inspection fees.--Beginning in fiscal 
                year 2010, there is authorized to be appropriated for 
                each fiscal year for device inspection fees under this 
                section such sums as may be necessary to carry out 
                device registration and inspection activities for such 
                fiscal year, except that such sums may be no greater 
                than the lesser of--
                            ``(i) the amount appropriated (excluding 
                        fees) for such activities for such fiscal year; 
                        or
                            ``(ii) the difference between the amount 
                        necessary to carry out such activities for such 
                        fiscal year (as provided in the report required 
                        by subsection (h)(2)(B)) and the amount 
                        appropriated (excluding fees) for such 
                        activities for such fiscal year.
    ``(f) Authority.--If the Secretary does not assess fees under 
subsection (b) during any portion of a fiscal year and if at a later 
date in such fiscal year the Secretary may assess such fees, the 
Secretary may assess and collect such fees, without any modification in 
the rate, at any time in such fiscal year notwithstanding the 
provisions of subsections (b) and (c) of section 510 relating to the 
date fees are to be paid.
    ``(g) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee required to be paid under subsection 
(b) within 30 days after it is due, such fee shall be treated as a 
claim of the United States Government subject to subchapter II of 
chapter 37 of title 31, United States Code.
    ``(h) Reports.--
            ``(1) Performance reports.--Beginning for fiscal year 2010, 
        not later than 120 days after the end of each fiscal year for 
        which fees are collected under this section, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions and the Committee on Appropriations of the 
        Senate and the Committee on Energy and Commerce and the 
        Committee on Appropriations of the House of Representatives--
                    ``(A) a report concerning the performance of the 
                Food and Drug Administration with respect to drug 
                registration and inspection activities during such 
                fiscal year; and
                    ``(B) a report concerning the performance of the 
                Food and Drug Administration with respect to device 
                registration and inspection activities during such 
                fiscal year.
            ``(2) Fiscal report.--Beginning for fiscal year 2010, not 
        later than 120 days after the end of each fiscal year for which 
        fees are collected under this section, the Secretary shall 
        prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions and the Committee on Appropriations of the 
        Senate and the Committee on Energy and Commerce and the 
        Committee on Appropriations of the House of Representatives--
                    ``(A) a report on--
                            ``(i) the implementation of the authority 
                        for drug establishment fees during such fiscal 
                        year;
                            ``(ii) the use, by the Food and Drug 
                        Administration, of such fees collected for such 
                        fiscal year; and
                            ``(iii) the amount necessary to carry out 
                        drug registration and inspection activities for 
                        the subsequent fiscal year (with a detailed 
                        explanation of the methodology used to 
                        determine such amount); and
                    ``(B) a report on--
                            ``(i) the implementation of the authority 
                        for device establishment fees during such 
                        fiscal year;
                            ``(ii) the use, by the Food and Drug 
                        Administration, of such fees collected for such 
                        fiscal year; and
                            ``(iii) the amount necessary to carry out 
                        device registration and inspection activities 
                        for the subsequent fiscal year (with a detailed 
                        explanation of the methodology used to 
                        determine such amount).
            ``(3) Public availability.--The Secretary shall make the 
        reports required under paragraphs (1) and (2) available to the 
        public on the Internet Web site of the Food and Drug 
        Administration.''.

SEC. 108. ELECTRONIC SUBMISSION AND CERTIFICATION OF REGISTRATIONS AND 
              LISTINGS.

    Section 510 (21 U.S.C. 360), as amended by section 106, is further 
amended by--
            (1) inserting after subsection (i) the following:
    ``(j) Electronic Submission and Certification.--Registrations and 
listings under this section (including the submission of updated 
information) shall be submitted and certified to the Secretary through 
the electronic portal described in subsection (i)(5)(A) (or by other 
electronic means until the Secretary establishes such portal) unless 
the Secretary grants a request for waiver of such requirement because 
use of electronic means is not reasonable for the person requesting 
such waiver.''; and
            (2) striking subsection (p).

SEC. 109. TECHNICAL AND CONFORMING AMENDMENTS.

    (a) Section 510.--
            (1) Listing numbers.--Section 510(e) (21 U.S.C. 360(e)) is 
        amended--
                    (A) by striking ``(e) The Secretary'' and all that 
                follows through ``Any number'' and inserting the 
                following:
    ``(e) Listing Number.--The Secretary may assign a listing number to 
each drug or class of drugs listed under subsection (i). Any number''; 
and
                    (B) by striking ``subsection (j)'' and inserting 
                ``subsection (i)''.
            (2) Exemptions.--Section 510(g) (21 U.S.C. 360(g)) is 
        amended by striking ``(g) The foregoing'' and inserting the 
        following:
    ``(g) Exemptions.--The foregoing''.
            (3) Device reports.--Section 510(k) (21 U.S.C. 360(k)) is 
        amended by striking ``(k) Each person'' and inserting the 
        following:
    ``(k) Device Reports.--Each person''.
            (4) No report required.--Section 510(l) (21 U.S.C. 360(l)) 
        is amended by striking ``(l) A report'' and inserting the 
        following:
    ``(l) No Report Required.--A report''.
            (5) Exemptions for class ii devices.--Section 510(m) (21 
        U.S.C. 360(m)) is amended--
                    (A) by striking ``(m)(1) Not later than'' and 
                inserting the following:
    ``(m) Exemptions for Class II Devices.--
            ``(1) List of exempted devices.--Not later than''; and
                    (B) by striking ``(2) Beginning'' and inserting the 
                following:
            ``(2) Other exempted devices.--Beginning''.
            (6) Review of report.--Section 510(n) (21 U.S.C. 360(n)) is 
        amended by striking ``(n) The Secretary'' and inserting the 
        following:
    ``(n) Review of Report.--The Secretary''.
            (7) Reprocessed single-use devices.--Section 510(o) (21 
        U.S.C. 360(o)) is amended--
                    (A) by striking ``(o)(1) With respect to'' and 
                inserting the following:
    ``(o) Reprocessed Single-Use Devices.--
            ``(1) Reprocessed single-use devices for which reports are 
        required.--With respect to'';
                    (B) in paragraph (1), by moving the indentation of 
                subparagraphs (A) through (D) 2 ems to the right;
                    (C) by striking ``(2) With respect to'' and 
                inserting the following:
            ``(2) Critical and semicritical reprocessed single-use 
        devices.--With respect to''; and
                    (D) in paragraph (2), by moving the indentation of 
                subparagraphs (A) through (E) 2 ems to the right.
    (b) Other Provisions.--The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended--
            (1) by striking ``510(i)'' each place it appears and 
        inserting ``510(c)'';
            (2) in section 301(p)--
                    (A) by striking ``510(j)'' and inserting 
                ``510(i)''; and
                    (B) by striking ``510(j)(2)'' and inserting 
                ``510(i)(2)'';
            (3) in section 502(o), by striking ``510(j)'' and inserting 
        ``510(i)''; and
            (4) in section 801(a), by striking ``subsection (i) of 
        section 510'' and inserting ``subsection (c) of section 510''.

SEC. 110. EFFECTIVE DATE.

    Except as otherwise provided in this subtitle, this subtitle, and 
the amendments made by this subtitle, shall take effect on October 1, 
2009.

     Subtitle B--Ensuring Identity and Sourcing of Drug Ingredients

SEC. 111. COMPENDIAL MODERNIZATION.

    (a) In General.--Section 501(b) (21 U.S.C. 351(b)) is amended by--
            (1) inserting ``or of the appropriate body charged with the 
        revision of such compendium'' after ``are, in the judgment of 
        the Secretary'';
            (2) inserting ``(1)'' after ``insufficient for the making 
        of such determination,'';
            (3) striking ``attention of the appropriate body charged 
        with the revision of such compendium'' and inserting 
        ``attention of such body''; and
            (4) inserting ``, or (2) such body shall bring such fact to 
        the attention of the Secretary, and the Secretary shall work 
        with such body to develop approaches that will allow such body 
        to establish sufficient standards'' after ``purity shall be 
        made''.
    (b) Rulemaking.--Section 701(e)(1) (21 U.S.C. 371(e)(1)) is amended 
in the first sentence by deleting ``501(b),''.
    (c) Assessment.--The Secretary of Health and Human Services, in 
consultation with the United States Pharmacopeia, other drug regulatory 
agencies, academic experts, and industry, shall periodically assess the 
tests and methods of assay for drugs found in official compendia to--
            (1) identify, considering current scientific methods, which 
        tests and methods of assay are no longer scientifically sound 
        and appropriate and of sufficient analytical precision and 
        specificity for their purpose; and
            (2) prioritize which such tests and methods of assay should 
        be revised, considering--
                    (A) the risks posed by a drug if its strength 
                differs, or its quality or purity falls below, the 
                compendia standards for such drug; and
                    (B) whether such tests and methods of assay are 
                sufficient to distinguish such drug from contaminants 
                or adulterants reasonably likely to be present in or on 
                such drug.

SEC. 112. TESTING OF DRUG PURITY AND IDENTITY.

    Section 501 (21 U.S.C. 351) is amended by adding at the end the 
following:
    ``(j) If it is a drug and it bears or contains an article, unless 
the manufacturer of such drug verifies the purity and identity of such 
article using scientifically sound and appropriate methods of 
sufficient analytical precision and specificity to detect and quantify 
the article separate from--
            ``(1) impurities; and
            ``(2) contaminants and adulterants reasonably likely to be 
        present in or on such article.''.

SEC. 113. MANUFACTURER RESPONSIBILITY FOR SOURCE AND QUALITY OF DRUG 
              INGREDIENTS.

    Section 501 (21 U.S.C. 351), as amended by section 112, is further 
amended by adding at the end the following:
    ``(k) If it is a drug and the manufacturer or importer fails to 
establish and maintain for a period of time determined by the Secretary 
documentation adequate to--
            ``(1) identify each establishment that manufactured, 
        processed, packed, or held each article that is a component of 
        the drug or a precursor ingredient of such a component; and
            ``(2) establish, including through appropriate and periodic 
        audits of the establishments described in paragraph (1), that 
        the drug and each such article is not adulterated under this 
        section or misbranded under section 502.''.

SEC. 114. CURRENT MANUFACTURING SCIENCE.

    Section 501(a) (21 U.S.C. 351(a)) is amended by striking ``; or 
(3)'' and inserting the following: ``or (D) if it is manufactured in a 
manner that is inconsistent with current manufacturing technologies, 
including quality risk-management practices, in-process controls, and 
relation of quality standards to clinical performance of the drug or 
device, as determined by the Secretary; or (3)''.

SEC. 115. COUNTRY OF ORIGIN LABELING.

    Section 502 (21 U.S.C. 352) is amended by inserting after 
subsection (c) the following:
    ``(d) If it is a drug in final dosage form or device for use on or 
by patients unless the Internet Web site of the manufacturer or 
distributor of the drug or device (whichever is identified on the label 
of the drug or device) lists, for each lot of such drug or device, the 
identity of--
            ``(1) the country of manufacture of the drug or device; and
            ``(2) if it is a drug, the country of manufacture of each 
        active ingredient of the drug.''.

SEC. 116. EFFECTIVE DATE; IMPLEMENTATION.

    (a) Effective Date.--Sections 112, 113, 114, and 115, and the 
amendments made by such sections, shall take effect on the date that is 
2 years after the date of enactment of this Act.
    (b) Implementation.--Not later than 18 months after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
issue a guidance for industry about how a drug may comply with the 
requirements of subsections (a)(2)(D), (j), and (k) of section 501 of 
the Federal Food, Drug, and Cosmetic Act (as added by this subtitle) 
and section 501(a)(2)(B) of such Act (21 U.S.C. 351(a)(2)(B)).

           Subtitle C--Ensuring Standards for Imported Drugs

SEC. 121. GOOD DISTRIBUTION AND IMPORT PRACTICES.

    (a) Good Distribution and Import Practices.--Section 501(a) (21 
U.S.C. 351(a)), as amended by section 114, is further amended by 
striking ``; or (3)'' and inserting ``or (E) if it is a drug and it is 
not distributed, shipped, warehoused, brokered, imported, or conveyed 
in conformity with current good distribution and import practices to 
assure the identity, strength, quality, and purity of the drug; or 
(3)''.
    (b) Inspection of Importers and Distributors of Drugs.--Section 704 
(21 U.S.C. 374) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)(A), by inserting ``(and in the 
                case of drugs, distributed, shipped, warehoused, or 
                conveyed),'' after ``or held,''; and
                    (B) in the third sentence--
                            (i) by inserting ``(and in the case of 
                        drugs, distributed, shipped, warehoused, or 
                        conveyed),'' after ``packed, or held,''; and
                            (ii) by inserting ``, (and in the case of 
                        drugs, distributed, shipped, warehoused, or 
                        conveyed),'' after ``transported, or held''; 
                        and
            (2) in subsection (e), by striking ``519 or'' and inserting 
        ``502(a)(2)(E), 519, or''.

SEC. 122. STANDARDS FOR ADMISSION OF IMPORTED DRUGS AND DRUG 
              INGREDIENTS.

    (a) In General.--Section 801 (21 U.S.C. 381) is amended--
            (1) in subsection (o), by striking ``drug or''; and
            (2) by adding at the end the following:
    ``(p)(1) Except as provided in paragraph (2), a drug, or an article 
that appears to be a drug, in finished dosage form, an article that is 
intended to be a component of a drug, or an article that is intended to 
be a precursor ingredient of such a component that is being imported or 
offered for import into the United States shall be refused admission 
unless the person importing or offering for import such drug or article 
provides to the Secretary, at the time of being imported or offered for 
import (and through an electronic portal as provided by the 
Secretary)--
            ``(A) all information submitted to U.S. Customs and Border 
        Protection in the entry declaration for such drug or such 
        article;
            ``(B) for a drug, or an article that appears to be a drug, 
        in finished dosage form--
                    ``(i) the listing number under section 510(e) of 
                such drug;
                    ``(ii) the D-U-N-S number of each establishment in 
                which such drug was manufactured, prepared, propagated, 
                compounded, or processed;
                    ``(iii) the new drug application number, the 
                biologics license application number, the abbreviated 
                new drug application number, the number of the 
                investigational new drug exemption for the drug, or the 
                drug monograph number, as applicable;
                    ``(iv) the label required by the new drug 
                application, the biologics license application number, 
                abbreviated new drug application, investigational new 
                drug exemption, or drug monograph, as applicable; and
                    ``(v) the record of inspections by the Secretary;
            ``(C) for an article that is an active ingredient of a 
        drug, or an article that is a precursor ingredient of an active 
        ingredient--
                    ``(i) the listing number under section 510(e) of 
                such article;
                    ``(ii) the D-U-N-S number of each establishment in 
                which such article was manufactured, prepared, 
                propagated, compounded, or processed;
                    ``(iii) the new drug application number, the 
                biologics license application number, the abbreviated 
                new drug application number, the number of the 
                investigational new drug exemption for the drug, or the 
                drug monograph number, as applicable, of the finished 
                dosage form for which such article is intended;
                    ``(iv) the label under a regulatory exemption from 
                section 502(f)(1); and
                    ``(v) the record of inspections by the Secretary or 
                by a governmental authority responsible for drugs 
                deemed adequate by the Secretary; and
            ``(D) for an article (other than an active ingredient) that 
        is intended to be a component of a drug, or an article that is 
        a precursor ingredient of any such component--
                    ``(i) the listing number under section 510(e) of 
                such article;
                    ``(ii) the D-U-N-S number of each establishment in 
                which such article was manufactured, prepared, 
                propagated, compounded, or processed;
                    ``(iii) the new drug application number, the 
                biologics license application number, the abbreviated 
                new drug application number, the number of the 
                investigational new drug exemption for the drug, or the 
                drug monograph number, as applicable, of the finished 
                dosage form for which such article is intended; and
                    ``(iv)(I) the record of inspections by the 
                Secretary or by a governmental authority responsible 
                for drugs deemed adequate by the Secretary;
                    ``(II) a quality certification by a private entity, 
                if the Secretary has agreed to accept such a 
                certification; and
                    ``(III) other evidence of quality that the 
                Secretary has deemed acceptable by regulation.
    ``(2) Paragraph (1) shall not apply to--
            ``(A) a drug to which subsection (g) applies; or
            ``(B) an article that--
                    ``(i) is intended to be subject to further 
                manufacturing for export as a drug, a device, or a 
                component of a drug or a device; and
                    ``(ii) is not deemed to be adulterated or 
                misbranded under subsection (e)(1).''.
    (b) Implementation.--Not later than 2 years after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
provide for an electronic portal for submission of the information 
required to be submitted under section 801(p) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a).

SEC. 123. PROHIBITION ON USE OF DRUGS AND DRUG INGREDIENTS NOT DECLARED 
              AS DRUGS ON IMPORTATION.

    Section 502 (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(aa) If it is a drug and it is, bears, or contains an article 
that, when imported or offered for import into the United States is 
intended to be a drug or a component of a drug, unless--
            ``(1) the label of such article, when so imported or 
        offered for import, contains the statement `for drug use'; and
            ``(2) the article is declared when so imported or offered 
        for import as `for drug use'.''.

SEC. 124. DESTRUCTION OF UNSAFE PRODUCTS REFUSED ADMISSION.

    Section 801(a) (21 U.S.C. 381(a)) is amended by striking the sixth 
sentence and inserting the following: ``The Secretary of the Treasury 
shall cause the destruction of any such article refused admission (1) 
if the Secretary of Health and Human Services informs the Secretary of 
the Treasury that such article appears to pose a risk of injury or 
death; or (2) if such article is not exported, under regulations 
prescribed by the Secretary of the Treasury, within 90 days of the date 
of notice of such refusal or within such additional time as may be 
permitted pursuant to such regulations. The preceding sentence shall 
not apply to drugs to which subsection (g) applies.''.

SEC. 125. EFFECTIVE DATE.

    This subtitle, and the amendments made by this subtitle, shall take 
effect on the date that is 30 days after the date of enactment of this 
Act.

             Subtitle D--Enhanced Response to Unsafe Drugs

SEC. 131. ADMINISTRATIVE DETENTION OF DRUGS.

    (a) In General.--Section 304(g) (21 U.S.C. 334(g)) is amended--
            (1) in paragraph (1)--
                    (A) by inserting ``drug or'' before ``device'' each 
                place it appears; and
                    (B) by inserting ``, or, in the case of a drug, 
                which the officer or employee making the inspection has 
                reason to believe is in violation of section 505,'' 
                after ``or misbranded''; and
            (2) in paragraph (2), by inserting ``drug or'' before 
        ``device'' each place it appears.
    (b) Technical Amendments.--Section 304(g)(1) (21 U.S.C. 334(g)(1)), 
as amended by subsection (a), is further amended by--
            (1) striking ``(1) If'' and inserting ``(1)(A) If'';
            (2) striking ``thirty days. Regulations'' and inserting the 
        following: ``thirty days.
    ``(B) Regulations'';
            (3) striking ``such order. A detention'' and inserting the 
        following: ``such order.
    ``(C) A detention''; and
            (4) striking ``as detained. Any person'' and inserting the 
        following: ``as detained.
    ``(D) Any person''.
    (c) Regulations.--Until the date that the Secretary of Health and 
Human Services issues a final regulation to implement the amendments to 
section 304(g) of the Federal Food, Drug, and Cosmetic Act (as made by 
subsection (a)), the regulations on administrative detention in section 
800.55 of title 21, Code of Federal Regulations, shall apply to any 
administrative detention of a drug under such section 304(g).

SEC. 132. MANDATORY RECALL AUTHORITY FOR DRUGS.

    (a) In General.--Chapter V (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).''.
    (b) 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 subsection (a)), 
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.

SEC. 133. RECORDS AND REPORTS OF DRUG DEFECTS AND DESTRUCTION OF 
              DEFECTIVE DRUGS THAT CANNOT BE RECONDITIONED.

    (a) In General.--Section 503 (21 U.S.C. 353) is amended by adding 
at the end the following:
    ``(h) Drug Defects.--
            ``(1) Records.--The manufacturer of a drug shall make and 
        maintain records about any defect of the drug.
            ``(2) Reports.--The manufacturer of a drug shall submit 
        reports to the Secretary about any defect of the drug that the 
        Secretary specifies in guidance in accordance with a schedule 
        specified by the Secretary in such guidance.
            ``(3) Investigation and corrective action.--The 
        manufacturer of a drug shall--
                    ``(A) investigate the cause of any defect of the 
                drug; and
                    ``(B) take appropriate corrective action.
            ``(4) Destruction.--If a drug may cause injury or death 
        because of a defect, the manufacturer shall, after the 
        investigation of the defect required under paragraph (3), 
        destroy the drug and shall not recondition the drug.
            ``(5) Defect.--For purposes of this subsection, a defect of 
        a drug shall include--
                    ``(A) microbiological or other contamination;
                    ``(B) significant chemical, physical, or other 
                change or deterioration;
                    ``(C) any deviation from purity or identity 
                identified under section 501(j); and
                    ``(D) any failure of 1 or more batches of the drug 
                to meet a specification established for it.''.
    (b) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended--
            (1) in subsection (d), by striking ``505'' and inserting 
        ``503(h), 505''; and
            (2) in subsection (e), by striking ``504'' and inserting 
        ``503(h), 504''.
    (c) Effective Date.--The amendments made by this section shall take 
effect on the date that is 180 days after the date of enactment of this 
Act.

SEC. 134. CIVIL MONEY PENALTIES.

    (a) In General.--Section 303(f) (21 U.S.C. 333(f)) is amended--
            (1) by redesignating paragraphs (5), (6), and (7) as 
        paragraphs (6), (7), and (8), respectively;
            (2) in paragraph (4), by striking ``or 505-1'' each place 
        it appears and inserting ``505-1, 505A, or 523A'';
            (3) by inserting after paragraph (4) the following:
            ``(5)(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).'';
            (4) in paragraph (6), as so redesignated, by striking ``, 
        or (4)'' each place it appears and inserting ``(4), or (5)'';
            (5) in paragraph (7), as so redesignated, by striking 
        ``(5)(A)'' and inserting ``(6)(A)''; and
            (6) in paragraph (8), as so redesignated, by striking 
        ``paragraph (6)'' each place it appears and inserting 
        ``paragraph (7)''.
    (b) Applicability.--Section 303(f)(5), as amended by subsection 
(a), shall apply to violations described in such section that occur 
after the date of enactment of this Act.

     Subtitle E--Additional Provisions Related to Medical Products

SEC. 141. CERTIFICATION OF INFORMATION.

    (a) Drugs.--Chapter V (21 U.S.C. 351 et seq.) is amended by 
inserting after section 505D the following:

``SEC. 505E. CERTIFICATION OF DRUG INFORMATION.

    ``(a) Certification.--
            ``(1) In general.--A submission, when submitted to the 
        Secretary, shall include a certification, in writing (which may 
        be in electronic form) and under penalty of perjury, by the 
        responsible person that--
                    ``(A) such person has actual knowledge of the 
                requirements under this Act and, if applicable, such 
                section 351, with respect to the drug that is the 
                subject of such submission;
                    ``(B) such person has actual knowledge of the 
                information related to such drug;
                    ``(C) such person has actual knowledge of the 
                information in such submission (and, if such submission 
                is an annual report, in any submission of any other 
                information with respect to such application or report 
                for which a certification under this paragraph is not 
                otherwise required);
                    ``(D) the information in such submission (and, if 
                such submission is an annual report, in any submission 
                of any other information with respect to such 
                application or report for which a certification under 
                this paragraph is not otherwise required) complies with 
                such requirements;
                    ``(E) the information in such submission (and, if 
                such submission is an annual report, in any submission 
                of any other information with respect to such 
                application or report for which a certification under 
                this paragraph is not otherwise required) is not false 
                or misleading; and
                    ``(F) full reports of all clinical trials and 
                postmarket studies (whether conducted within or outside 
                the United States) related to the safety or 
                effectiveness of the drug under review that were funded 
                by the sponsor of such submission, or the full reports 
                of which the sponsor of such submission had access, 
                have been submitted to the Food and Drug 
                Administration.
            ``(2) Definitions.--In this section:
                    ``(A) Responsible person.--The term `responsible 
                person' means, with respect to a submission, a senior 
                officer or director of the sponsor of such submission 
                with knowledge of, and management responsibility for, 
                such submission.
                    ``(B) Submission.--The term `submission' means--
                            ``(i) new drug application under section 
                        505(b);
                            ``(ii) an abbreviated new drug application 
                        under section 505(j);
                            ``(iii) a biologics license application 
                        under section 351 of the Public Health Service 
                        Act;
                            ``(iv) an application for an 
                        investigational new drug exemption under 
                        section 505(i);
                            ``(v) a new animal drug application under 
                        section 512(b);
                            ``(vi) an abbreviated new animal drug 
                        application under section 512(b);
                            ``(vii) an application under section 571;
                            ``(viii) a request under section 572;
                            ``(ix) or a major amendment, supplement, or 
                        an annual report submitted to the Secretary 
                        with respect to any application or request 
                        described in clauses (i) through (viii);
                            ``(x) a record or report related to the 
                        safety or effectiveness of a drug subject to 
                        section 505 or such section 351, to an adverse 
                        event under section 505(k) or 760, or to a 
                        postapproval study or postapproval clinical 
                        trial under section 505(o); or
                            ``(xi) a list under section 510(i) 
                        including a drug.
    ``(b) Inspections.--
            ``(1) In general.--If the Secretary determines, after 
        notice and opportunity for an informal hearing, that a sponsor 
        described in subsection (a)(2) knew or should have known that 
        the information in a submission described in subsection (a)(1) 
        did not comply with the requirements of this Act or was false 
        or misleading, the Secretary may provide that any factory, 
        warehouse, establishment, or consulting laboratory related to 
        such noncompliance or such false or misleading information 
        shall be inspected periodically by officers or employees duly 
        designated by the Secretary for a period of time determined by 
        the Secretary, not to exceed 5 years.
            ``(2) Costs.--The Secretary shall assess the costs of such 
        inspections to such sponsor.''.
    (b) Devices.--Chapter V (21 U.S.C. 351 et seq.) is amended by 
inserting after section 523 the following:

``SEC. 523A. CERTIFICATION OF DEVICE INFORMATION.

    ``(a) Certification.--
            ``(1) Certification by sponsor.--A submission, when 
        submitted to the Secretary, shall include a certification, in 
        writing and under penalty of perjury, by the responsible person 
        that--
                    ``(A) such person has actual knowledge of the 
                requirements under this Act with respect to the device 
                that is the subject of such submission;
                    ``(B) such person has actual knowledge of the 
                information related to such device;
                    ``(C) such person has actual knowledge of the 
                information in such submission (and, if such submission 
                is an annual report, in any submission of any other 
                information with respect to such application or report 
                for which a certification under this paragraph is not 
                otherwise required);
                    ``(D) the information in such submission (and, if 
                such submission is an annual report, in any submission 
                of any other information with respect to such 
                application or report for which a certification under 
                this paragraph is not otherwise required) complies with 
                such requirements;
                    ``(E) the information in such submission (and, if 
                such submission is an annual report, in any submission 
                of any other information with respect to such 
                application or report for which a certification under 
                this paragraph is not otherwise required) is not false 
                or misleading; and
                    ``(F) full reports of all clinical trials and 
                postmarket studies (whether conducted within or outside 
                the United States) related to the safety or 
                effectiveness of the device under review that were 
                funded by the sponsor of such submission, or the full 
                reports of which the sponsor of such submission had 
                access, have been submitted to the Food and Drug 
                Administration.
            ``(2) Definitions.--In this section:
                    ``(A) Responsible person.--The term `responsible 
                person' means, with respect to a submission, a senior 
                officer or director of the sponsor of such submission 
                with knowledge of, and management responsibility for, 
                such submission.
                    ``(B) Submission.--The term `submission' means--
                            ``(i) an application or report for 
                        premarket approval under section 515;
                            ``(ii) an application for an 
                        investigational device exemption under section 
                        520(g);
                            ``(iii) a report under section 510(k);
                            ``(iv) an application for a humanitarian 
                        device exemption under section 520(m);
                            ``(v) a major amendment, supplement, or an 
                        annual report submitted to the Secretary with 
                        respect to any application or report described 
                        in clauses (i) through (iv);
                            ``(vi) a record or report related to an 
                        adverse event, a report, or postmarket 
                        surveillance under section 519 or 522; or
                            ``(vii) a list under section 510(i) 
                        including a device,
    ``(b) Inspections.--
            ``(1) In general.--If the Secretary determines, after 
        notice and opportunity for an informal hearing, that a sponsor 
        described in subsection (a)(2) knew or should have known that 
        the information in a submission described in subsection (a)(1) 
        did not comply with the requirements of this Act or was false 
        or misleading, the Secretary may provide that any factory, 
        warehouse, establishment, or consulting laboratory related to 
        such noncompliance or such false or misleading information 
        shall be inspected periodically by officers or employees duly 
        designated by the Secretary for a period of time determined by 
        the Secretary, not to exceed 5 years.
            ``(2) Costs.--The Secretary shall assess the costs of such 
        inspections to such sponsor.''.
    (c) Criminal Penalties.--Chapter 47 of title 18, United States 
Code, is amended by adding at the end the following:
``Sec. 1041. Certifications related to drug and device information
    ``(a) If a responsible person--
            ``(1) certifies any submission as set forth in section 505E 
        or 523A of the Federal Food, Drug, and Cosmetic Act knowing 
        that a component of such certification is false or misleading, 
        then--
                    ``(A) the sponsor of such submission shall be fined 
                not more than $1,000,000; and
                    ``(B) such responsible person shall be fined not 
                more than $1,000,000, imprisoned for not more than 10 
                years, or both; or
            ``(2) willfully certifies any submission as set forth in 
        section 505E or 523A of the Federal Food, Drug, and Cosmetic 
        Act knowing that a component of such certification is false or 
        misleading, then--
                    ``(A) the sponsor of such submission shall be fined 
                not more than $5,000,000; and
                    ``(B) such responsible person shall be fined not 
                more than $5,000,000, imprisoned not more than 20 
                years, or both.
    ``(b) In this section:
            ``(1) The term `responsible person'--
                    ``(A) with respect to a submission related to a 
                drug, has the meaning given that term in section 
                505E(a)(2) of the Federal Food, Drug, and Cosmetic Act; 
                and
                    ``(B) with respect to a submission related to 
                device, has the meaning given that term in section 
                523A(a)(2) of such Act.
            ``(2) The term `submission' means--
                    ``(A) with respect to a drug--
                            ``(i) a new drug application under section 
                        505(b) of the Federal Food, Drug, and Cosmetic 
                        Act;
                            ``(ii) an abbreviated new drug application 
                        under section 505(j) of such Act;
                            ``(iii) a biologics license application 
                        under section 351 of the Public Health Service 
                        Act;
                            ``(iv) an application for an 
                        investigational new drug exemption under 
                        section 505(i) of the Federal Food, Drug, and 
                        Cosmetic Act;
                            ``(v) a new animal drug application under 
                        section 512(b) of the Federal Food, Drug, and 
                        Cosmetic Act;
                            ``(vi) an abbreviated new animal drug 
                        application under section 512(b) of such Act;
                            ``(vii) an application under section 571 of 
                        such Act;
                            ``(viii) a request under section 572 of 
                        such Act;
                            ``(ix) a major amendment, supplement, or 
                        other information submitted to the Secretary 
                        with respect to any application or request 
                        described in clauses (i) through (viii);
                            ``(x) a record or report related to the 
                        safety or effectiveness of a drug subject to 
                        section 505 of such Act or section 351 of the 
                        Public Health Service Act, to an adverse event 
                        under section 505(k) or 760 of the Federal 
                        Food, Drug, and Cosmetic Act, or to a 
                        postapproval study or postapproval clinical 
                        trial under section 505(o) of such Act; or
                            ``(xi) a list under section 510(i) 
                        including the drug; and
                    ``(B) with respect to a device--
                            ``(i) an application or report for 
                        premarket approval under section 515 of the 
                        Federal Food, Drug, and Cosmetic Act;
                            ``(ii) an application for an 
                        investigational device exemption under section 
                        520(g) of such Act;
                            ``(iii) a report under section 510(k) of 
                        such Act;
                            ``(iv) an application for a humanitarian 
                        device exemption under section 520(m) of such 
                        Act;
                            ``(v) a major amendment, supplement, or 
                        other information submitted to the Secretary 
                        with respect to any application or report 
                        described in clauses (i) through (iv);
                            ``(vi) a record or report related to an 
                        adverse event, a report, or postmarket 
                        surveillance under section 519 or 522 of such 
                        Act; or
                            ``(vii) a list under section 510(i) 
                        including the device.''.
    (d) Conforming Amendment.--The table of sections for chapter 47 of 
title 18, United States Code, is amended by inserting after the item 
relating to section 1040 the following:

``1041. Certification of drug and device information.''.

SEC. 142. WHISTLEBLOWER PROTECTIONS.

    Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at the end 
the following:

``SEC. 911. 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.''.

SEC. 143. STUDY BY THE INSTITUTE OF MEDICINE REGARDING THE REVIEW OF 
              MEDICAL DEVICES.

    (a) In General.--The Secretary of Health and Human Services shall 
enter into a contract with the Institute of Medicine to conduct a study 
to--
            (1) evaluate the organizational structure and operations of 
        the Food and Drug Administration with respect to the review of 
        medical devices for clearance under section 510(k) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) and for 
        premarket approval under section 515 of such Act (21 U.S.C. 
        360e);
            (2) evaluate the analytical and methodological tools used 
        by such Administration to conduct such reviews; and
            (3) identify strengths, weaknesses, and limitations of the 
        system used by such Administration to conduct such reviews.
    (b) Report.--Not later than September 31, 2010, the Institute of 
Medicine shall complete the study described under subsection (a) and 
submit to the Secretary of Health and Human Services, the Committee on 
Health, Education, Labor, and Pensions and the Committee on Finance of 
the Senate, and the Committee on Energy and Commerce of the House of 
Representatives a report that--
            (1) describes the findings of such study; and
            (2) makes recommendations regarding the organization 
        structure and operations of the Food and Drug Administration, 
        legislation, and regulation to improve or enhance the review of 
        medical devices by such Administration.

 TITLE II--GENERAL AUTHORITIES TO ENHANCE FOOD AND DRUG ADMINISTRATION 
               OVERSIGHT OF PRODUCTS FROM A GLOBAL MARKET

SEC. 201. DEDICATED FOREIGN INSPECTORATE.

    Section 704 (21 U.S.C. 374) is amended by adding at the end the 
following:
    ``(h) Foreign Inspectorate.--
            ``(1) In general.--The Secretary shall establish and 
        maintain a corps of inspectors dedicated to inspections of 
        foreign establishments registered under section 510 and foreign 
        facilities registered under section 415. Such corps shall 
        include personnel, in numbers sufficient to act as inspectors 
        or translators for inspectors on each inspection by such corps, 
        who are able to understand and speak the language used in the 
        establishment or facility under inspection.
            ``(2) Organization.--The corps established under paragraph 
        (1) shall be organized into the following 4 units:
                    ``(A) A unit with expertise in inspections of food 
                facilities.
                    ``(B) A unit with expertise in inspections of human 
                drug establishments.
                    ``(C) A unit with expertise in inspections of 
                animal drug establishments.
                    ``(D) A unit with expertise in inspections of 
                medical device establishments.
            ``(3) Staffing and funding.--Each unit shall be staffed and 
        funded by the Secretary at a level sufficient to allow the unit 
        to conduct inspections, as applicable--
                    ``(A) of foreign establishments registered under 
                section 510 at a frequency, considering risk, that is 
                comparable to the inspection rate of domestic 
                establishments registered under section 510; or
                    ``(B) of foreign facilities registered under 
                section 415 at a frequency, considering risk, that is 
                comparable to the inspection rate of domestic 
                facilities registered under section 415.
            ``(4) Distribution.--The Secretary shall distribute the 
        staff of each unit described in paragraph (2) in countries, and 
        may modify such distribution over time, considering--
                    ``(A) the volume of product exported from such 
                country to the United States;
                    ``(B) an assessment of the effectiveness of the 
                regulatory oversight provided by such country for such 
                products;
                    ``(C) an assessment of the risk posed by such 
                products; and
                    ``(D) such other factors as the Secretary 
                determines are relevant to such distribution.''.

SEC. 202. AUTHORITY TO EXCHANGE CONFIDENTIAL INFORMATION WITH FOREIGN 
              GOVERNMENT OFFICIALS.

    (a) Authority To Exchange Confidential Information With Foreign 
Government Officials.--Section 803 (21 U.S.C. 383) is amended by adding 
the following:
    ``(d) Exchange of Confidential Information.--
            ``(1) Disclosure by secretary.--The Secretary may disclose 
        information about food, drugs, devices, and cosmetics to 
        officials of a foreign government if--
                    ``(A) such government is able, and agrees, to guard 
                the confidentiality and guarantee nondisclosure of such 
                information; and
                    ``(B) the Secretary determines that such disclosure 
                is necessary to promote a regulatory, enforcement, or 
                other public health function.
            ``(2) Disclosure to secretary.--The Secretary may receive 
        information from officials of foreign governments under 
        conditions of confidentiality. Such information shall be exempt 
        from disclosure under section 552 of title 5, United States 
        Code.''.
    (b) Conforming Amendment.--Section 301(j) (21 U.S.C. 331(j)) is 
amended by inserting ``or pursuant to section 803(d),'' after 
``judicial proceeding under this Act,''.

SEC. 203. SUBPOENA AUTHORITY.

    Section 702 (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.''.

SEC. 204. INFORMATION REPORTING.

    Subchapter G of chapter VII (21 U.S.C. 379v et seq.) is amended by 
adding at the end the following:

``SEC. 757. INFORMATION REPORTING.

    ``(a) Notification of Settlements or Judgments.--If a particular 
product regulated by the Secretary under this Act or section 351 of the 
Public Health Service Act is the subject of at least 3 civil actions 
that have been filed in Federal or State court alleging death, serious 
injury, or serious illness caused in whole or in part by such product 
which, in any 24-month period, result in either a final settlement 
involving the manufacturer or a court judgment in favor of the 
plaintiff, the manufacturer of such product shall, in accordance with 
subsection (b), report to the Secretary each such civil action not 
later than 30 days after the final settlement or court judgment in the 
third of such civil actions, and report to the Secretary any other such 
action not later than 30 days after any subsequent such settlement or 
judgment that--
            ``(1) occurs within 24 months of any other 2 such 
        settlements or judgments; and
            ``(2) has not been previously reported to the Secretary 
        under this section.
    ``(b) Information To Be Reported.--
            ``(1) Required information.--The information required by 
        subsection (a) to be reported to the Secretary, with respect to 
        each civil action described in such subsection, shall include 
        and, in addition to any voluntary information provided under 
        paragraph (2), shall be limited to the following:
                    ``(A) The name and address of the manufacturer.
                    ``(B) The name or model of the product subject to 
                the civil action.
                    ``(C) A statement as to whether the civil action 
                alleged death, injury, or illness and in the case of an 
                allegation of injury, a statement of the category of 
                such injury.
                    ``(D) A statement as to whether the civil action 
                resulted in a final settlement or a judgment in favor 
                of the plaintiff.
                    ``(E) In the case of a judgment in favor of the 
                plaintiff, the name of the civil action, the number 
                assigned the civil action, and the court in which the 
                civil action was filed.
            ``(2) Voluntary information.--A manufacturer furnishing the 
        report required by paragraph (1) may include--
                    ``(A) a statement as to whether any judgment in 
                favor of the plaintiff is under appeal or is expected 
                to be appealed; or
                    ``(B) any other information which the manufacturer 
                chooses to provide.
    ``(c) Safety Report.--A report of a civil action described in 
subsection (a) shall be considered a safety report under section 756 
and may be accompanied by a statement, which shall be part of any 
report released for public disclosure, that denies that the report 
constitutes an admission that the product involved caused or 
contributed to a death, serious injury, or serious illness.
    ``(d) Admission.--A report of a civil action described in 
subsection (a) shall not be considered an admission that the product 
involved is adulterated or caused or contributed to a death, serious 
injury, or serious illness.
    ``(e) Definitions.--The terms `serious illness' and `serious 
injury' mean illness or injury, respectively, that--
            ``(1) is life threatening,
            ``(2) results in permanent impairment of a body function or 
        permanent damage to a body structure, or
            ``(3) necessitates medical or surgical intervention to 
        preclude permanent impairment of a body function or permanent 
        damage to a body structure.''.
                                 <all>