[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3409 Introduced in Senate (IS)]







110th CONGRESS
  2d Session
                                S. 3409

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

                             July 31, 2008

 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 2008''.

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 and licensing of drug importers.
Sec. 103. Inspection of drug and device establishments.
Sec. 104. Listing of drugs and devices; enhanced information technology 
                            system for registration and listing.
Sec. 105. Registration and inspection fees for drug and device 
                            establishments.
Sec. 106. Technical and conforming amendments.
Sec. 107. Effective date.
     Subtitle B--Ensuring Identity and Sourcing of Drug Ingredients

Sec. 111. Testing of drug purity and identity.
Sec. 112. Manufacturer responsibility for source and quality of drug 
                            ingredients.
Sec. 113. Current manufacturing science.
Sec. 114. Electronic pedigree for drug ingredients.
Sec. 115. Country of origin labeling.
Sec. 116. Effective date.
           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.
 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.

    (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 Establishments for Drug Precursor and Inactive 
Ingredients.--
            (1) Registration.--Section 510(a) (21 U.S.C. 360(a)) is 
        amended--
                    (A) in the matter preceding paragraph (1), by 
                striking ``As used'' and inserting ``Definitions.--As 
                used'';
                    (B) by redesignating paragraphs (1) and (2) as 
                paragraphs (2) and (3), respectively; and
                    (C) by inserting after ``this section--'' the 
                following:
            ``(1) Drug.--The term `drug' includes a precursor 
        ingredient.''.
            (2) 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 a component 
of a drug, means an article that is a material--
            ``(1) of animal origin from which such component is 
        derived; or
            ``(2) used in the final stage of synthesis or purification 
        of such component.''.
            (3) Termination of effect of regulation.--On the date that 
        is 180 days after the date of enactment of this Act, the 
        exemption from registration in subsection (e) of section 207.10 
        of title 21, Code of Federal Regulations, shall cease to have 
        force or effect.
    (c) Registration of Domestic 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 
        registration and inspection fee for each such establishment 
        required under section 741;
            ``(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).
    (d) Registration of Foreign Establishments.--Section 510 (U.S.C. 
360) is amended--
            (1) by transferring subsection (i) so as to appear after 
        subsection (b) (as amended by subsection (c)); 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 registration and inspection 
                fee for each such establishment required under section 
                741, 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'' and 
                inserting ``(2) Cooperative arrangements.--''; and
                    (D) by moving the indentation of paragraph (2), as 
                amended, 2 ems to the right.

SEC. 102. REGISTRATION AND LICENSING OF DRUG IMPORTERS.

    Section 510 (21 U.S.C. 360), as amended by section 101, 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 drugs 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. 103. INSPECTION OF DRUG AND DEVICE ESTABLISHMENTS.

    (a) Requiring Equal Treatment of Domestic and Foreign 
Establishments.--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'';
            (3) striking ``section shall'' and inserting: ``section--
                    ``(A) shall'';
            (4) striking ``704 and every such'' and inserting ``704;
                    ``(B) except as provided in paragraph (2), and for 
                establishments that manufacture, prepare, propagate, 
                compound, or process only inactive ingredients, 
                every''; and
            (5) striking ``thereafter.'' and inserting ``thereafter; 
        and
                    ``(C) shall not be considered duly registered under 
                this section if an inspection of such establishment by 
                the Secretary is refused, delayed, or limited by--
                            ``(i) the person who owns or operates such 
                        establishment, or any agent or employee of such 
                        person; or
                            ``(ii) any agent of a governmental 
                        authority in the foreign country within which 
                        such establishment is located.''.
    (b) Providing for Risk-Based Inspections of Establishments.--
Section 510(h) (21 U.S.C. 360(h)), as amended by subsection (a), is 
further amended by adding at the end the following:
            ``(2) Risk-based inspection schedule.--
                    ``(A) In general.--The Secretary may by regulation 
                provide for an inspection schedule for establishments 
                described in paragraph (1) (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 of 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 drugs or devices 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 establishment.''.
    (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:
            ``(3) 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)(i) the number and identities 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 (2)(A) with different frequencies of 
                inspection for different classes of establishments, the 
                numbers and identities for each such class;
                    ``(C)(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 (2)(A) with expected frequencies of 
                inspection for different classes of establishments, the 
                numbers for each such class;
                    ``(D) 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;
                    ``(E) the number of domestic and foreign 
                establishments registered with the Secretary under this 
                section during the previous calendar year; and
                    ``(F) other information deemed relevant by the 
                Secretary.
            ``(4) Public availability of annual reports.--The Secretary 
        shall make the report required under paragraph (3) available to 
        the public on the Internet Web site of the Food and Drug 
        Administration.''.

SEC. 104. LISTING OF DRUGS AND DEVICES; ENHANCED INFORMATION TECHNOLOGY 
              SYSTEM FOR REGISTRATION AND LISTING.

    (a) In General.--Section 510 (21 U.S.C. 360) is amended--
            (1) in subsection (j)--
                    (A) 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)'';
                    (B) in paragraph (1)--
                            (i) by moving the indentation of 
                        subparagraphs (A) through (D) 2 ems to the 
                        right; and
                            (ii) in subparagraph (B), by moving the 
                        indentation of clauses (i) and (ii) 2 ems to 
                        the right;
                    (C) in paragraph (2)--
                            (i) 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
                            (ii) by moving the indentation of 
                        subparagraphs (A) through (D) 2 ems to the 
                        right;
                    (D) in paragraph (3), by striking ``(3) The 
                Secretary'' and inserting the following:
            ``(3) Additional list.--The Secretary''; and
                    (E) 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 
                or inactive ingredient.
            ``(5) Electronic submission and maintenance of 
        information.--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)(2) to such establishment; and
                            ``(iii) is interoperable and communicates 
                        with other relevant databases within the Food 
                        and Drug Administration.''.

SEC. 105. REGISTRATION AND INSPECTION FEES FOR DRUG AND DEVICE 
              ESTABLISHMENTS.

    (a) Redesignation.--Chapter VII (21 U.S.C. 371 et seq.) is amended 
by redesignating sections 741, 742, and 746 as sections 746, 747, and 
749, respectively.
    (b) 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 5--FEES RELATED TO ESTABLISHMENT INSPECTIONS

``SEC. 741. AUTHORITY TO ASSESS AND USE FEES.

    ``(a) Types of Fees.--
            ``(1) Drug registration and inspection fees.--Beginning in 
        fiscal year 2009, the Secretary shall collect drug registration 
        and 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 registration and inspection fee 
                established under subsection (b)(1).
                    ``(B) Reduction for positron emission tomography 
                drugs.--The drug registration and 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 registration and 
                inspection fee otherwise applicable to such 
                establishment under subsection (b)(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 
                registration and inspection fee.
                    ``(D) Waiver or reduction.--The Secretary shall 
                grant a waiver from or reduction of the drug 
                registration and inspection fee as provided for under 
                section 736(d).
            ``(2) Device registration and inspection fees.--Beginning 
        in fiscal year 2009, the Secretary shall collect device 
        registration and 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 
                registration and inspection fee established under 
                subsection (b)(2).
                    ``(B) Reduction for small businesses.--The device 
                registration and 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 registration and 
                inspection fee otherwise applicable to such 
                establishment under subsection (b)(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 registration and inspection 
                fee unless a device classified in class II or class III 
                manufactured by the establishment is to be distributed 
                commercially.
    ``(b) Fee Amounts.--
            ``(1) Drug registration and inspection fee amounts.--
                    ``(A) In general.--Beginning with fiscal year 2009, 
                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 (d), 
                establish for such fiscal year, and publish in the 
                Federal Register, drug registration and inspection 
                fees, based on the amount provided for in advance in 
                appropriations Acts for such fees as described in 
                subsection (d), considering--
                            ``(i)(I) the registration and inspection 
                        fee for a drug establishment that under the 
                        inspection schedule provided for under section 
                        510(h)(2)(A) is to be inspected more frequently 
                        than once in every 2-year period shall be more 
                        than the registration and 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; 
                        and
                            ``(II) the registration and inspection fee 
                        for a drug establishment that under the 
                        inspection schedule provided for under section 
                        510(h)(2)(A) is to be inspected less frequently 
                        than once in every 2-year period shall be less 
                        than the registration and 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;
                            ``(ii) the reductions required under 
                        subparagraphs (B) and (D) of subsection (a)(1); 
                        and
                            ``(iii) the number of drug establishments 
                        subject to such a fee, considering 
                        subparagraphs (C) and (D) of subsection (a)(1).
                    ``(B) Foreign drug establishment.--For a foreign 
                drug establishment, the drug registration and 
                inspection fee shall be--
                            ``(i) the applicable drug registration and 
                        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.
            ``(2) Device registration and inspection fee amounts.--
                    ``(A) In general.--Beginning with fiscal year 2009, 
                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 (d) 
                establish for such fiscal year, and publish in the 
                Federal Register device registration and inspection 
                fees, based on the amount provided for in advance in 
                appropriations Acts for such fees and considering--
                            ``(i)(I) the registration and inspection 
                        fee for a device establishment that under the 
                        inspection schedule provided for under section 
                        510(h)(2)(A) is to be inspected more frequently 
                        than once in every 2-year period shall be more 
                        than the registration and 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; 
                        and
                            ``(II) the registration and inspection fee 
                        for a device establishment that under the 
                        inspection schedule provided for under section 
                        510(h)(2)(A) is to be inspected less frequently 
                        than once in every 2-year period shall be less 
                        than the registration and 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;
                            ``(ii) the reduction required under 
                        subsection (a)(2)(B); and
                            ``(iii) the number of device establishments 
                        subject to such a fee, considering subsection 
                        (a)(2)(C).
                    ``(B) Foreign device establishment.--For a foreign 
                device establishment, the device registration and 
                inspection fee shall be--
                            ``(i) the applicable device registration 
                        and 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) Effect of Failure To Pay Fees.--
            ``(1) Drug registration and inspection fee.--An 
        establishment subject to a drug registration and inspection fee 
        under subsection (a) shall be considered not to be registered 
        under section 510 until all registration and inspection fees 
        under this section owed by the person required to register such 
        establishment have been paid.
            ``(2) Device registration and inspection fee.--An 
        establishment subject to a device registration and inspection 
        fee under subsection (a) shall be considered not to be 
        registered under section 510 until all registration and 
        inspection fees under this section owed by the person required 
        to register such establishment have been paid.
    ``(d) Crediting and Availability of Fees.--
            ``(1) Drug registration and inspection fees.--Drug 
        registration and inspection fees authorized under subsection 
        (a) 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 registration and inspection fees.--Device 
        registration and inspection fees authorized under subsection 
        (a) 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 registration and inspection fees.--
                Beginning in fiscal year 2009, there is authorized to 
                be appropriated for each fiscal year for drug 
                registration and inspection fees under this section 
                such sums as may be necessary to carry out drug 
                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) one-half of the amount necessary to 
                        carry out such activities for such fiscal year.
                    ``(B) Device registration and inspection fees.--
                Beginning in fiscal year 2009, there is authorized to 
                be appropriated for each fiscal year for device 
                registration and 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) one-half of the amount necessary to 
                        carry out such activities for such fiscal year.
    ``(e) Authority.--If the Secretary does not assess fees under 
subsection (a) 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.
    ``(f) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a registration and inspection fee required 
to be paid under subsection (a) 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.
    ``(g) Reports.--
            ``(1) Performance report.--Beginning for fiscal year 2009, 
        not later than 120 days after the end of each fiscal year for 
        which drug registration and inspection fees and device 
        registration and inspection 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 report concerning the performance of 
        the Food and Drug Administration with respect to--
                    ``(A) drug registration and inspection activities 
                during such fiscal year; and
                    ``(B) device registration and inspection activities 
                during such fiscal year.
            ``(2) Fiscal report.--Beginning for fiscal year 2009, not 
        later than 120 days after the end of each fiscal year for which 
        drug registration and inspection fees and device registration 
        and inspection 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 report on the implementation of the authority 
        for such fees during such fiscal year and the use, by the Food 
        and Drug Administration, of the fees collected for such fiscal 
        year.
            ``(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.
    ``(h) 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 engaged 
                in the manufacture, preparation, propagation, 
                compounding, or processing of a device classified in 
                class II or class III; or
                    ``(B) an establishment within any foreign country 
                that is 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.
            ``(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)(1)(B) or, if applicable, section 
                510(h)(2).
                    ``(D) The review of inspection reports from such 
                inspections.
                    ``(E) Any action under this Act pursuant to such 
                registration, listing, inspections, and 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)(1)(B) or (h)(2) 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)(1)(B) or (h)(2) 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)(1)(B) or, if applicable, section 
                510(h)(2).
                    ``(D) The review of inspection reports from such 
                inspections.
                    ``(E) Any action under this Act pursuant to such 
                registration, listing, inspections, and reviews.
            ``(6) Person.--The term `person' includes an affiliate 
        thereof.''.

SEC. 106. 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) Inspection by public of registration.--Section 510(f) 
        (21 U.S.C. 360(f)) is amended--
                    (A) by striking ``(f) The Secretary'' and inserting 
                the following:
    ``(f) Inspection by Public of Registration.--''; and
                    (B) by striking ``subsection (j)'' and inserting 
                ``subsection (i)''.
            (3) Exemptions.--Section 510(g) (21 U.S.C. 360(g)) is 
        amended--
                    (A) by striking ``(g) The foregoing'' and inserting 
                the following:
    ``(g) Exemptions.--The foregoing''; and
                    (B) by moving the indentation of paragraphs (1) 
                through (5) 2 ems to the right.
            (4) Electronic submission.--Section 510 (21 U.S.C. 360) is 
        amended by inserting after subsection (i) (as redesignated by 
        section 104) the following:
    ``(j) Electronic Submission.--Registrations and listings under this 
section (including the submission of updated information) shall be 
submitted to the Secretary by electronic means 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.''.
            (5) Device reports.--Section 510(k) (21 U.S.C. 360(k)) is 
        amended--
                    (A) by striking ``(k) Each person'' and inserting 
                the following:
    ``(k) Device Reports.--Each person''; and
                    (B) by moving the indentation of paragraphs (1) and 
                (2) 2 ems to the right.
            (6) 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''.
            (7) 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''.
            (8) 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''.
            (9) 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.
            (10) Electronic submission.--Section 510 (21 U.S.C. 360) is 
        amended by striking subsection (p).
    (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--
                    (A) in subsection (p)--
                            (i) by striking ``510(j),'' and inserting 
                        ``510(i),''; and
                            (ii) by striking ``510(j)(2)'' and 
                        inserting ``510(i)(2)''; and
                    (B) in subsection (o), by striking ``510(j)'' and 
                inserting ``510(i)''; and
            (3) in section 801(a), by striking ``subsection (i) of 
        section 510'' and inserting ``subsection (c) of section 510''.

SEC. 107. EFFECTIVE DATE.

    This subtitle, and the amendments made by this subtitle, shall take 
effect on October 1, 2008.

     Subtitle B--Ensuring Identity and Sourcing of Drug Ingredients

SEC. 111. TESTING OF DRUG PURITY AND IDENTITY.

    (a) In General.--Section 501 (21 U.S.C. 351) is amended by adding 
at the end the following:
    ``(j) If it is a drug--
            ``(1) 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--
                    ``(A) impurities; and
                    ``(B) contaminants and adulterants reasonably 
                likely to be present in or on such article;
            ``(2) unless the manufacturer of such drug periodically 
        evaluates the impurity profile of each active ingredient of 
        such drug to verify that such profile is substantially similar 
        to the profile of the lot or lots of such ingredient used in 
        the clinical investigations or toxicological evaluations of 
        such drug submitted to the Secretary under section 505 or 
        section 351 of the Public Health Service Act; and
            ``(3) unless the manufacturer of such drug reports to the 
        Secretary--
                    ``(A) any deviation from purity and identity 
                identified under paragraph (1) or (2); and
                    ``(B) any necessary actions in response to such a 
                deviation to assure the safety and effectiveness of the 
                drug.''.
    (b) Compendial Modernization.--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 ``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''.
    (c) Rulemaking.--Section 701(e)(1) (21 U.S.C. 371(e)(1)) is amended 
in the first sentence by deleting ``501(b),''.
    (d) 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 
determine whether, considering current scientific methods, such tests 
and methods of assay remain scientifically sound and appropriate and of 
sufficient analytical precision and specificity for their purpose.

SEC. 112. MANUFACTURER RESPONSIBILITY FOR SOURCE AND QUALITY OF DRUG 
              INGREDIENTS.

    Section 501 (21 U.S.C. 351), as amended by section 111, 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. 113. 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. 114. ELECTRONIC PEDIGREE FOR DRUG INGREDIENTS.

    Section 502 (21 U.S.C. 352) is amended by inserting after 
subsection (c) the following:
    ``(d) If it is a drug and any article that is a component of the 
drug or a precursor ingredient of such a component was distributed by a 
person, unless such person distributed with the article an electronic 
statement (in such form and containing such information as the 
Secretary may require by guidance or regulation) identifying each prior 
sale, purchase, or trade of the article (including the date of the 
transaction and the names and addresses of all parties to the 
transaction).''.

SEC. 115. COUNTRY OF ORIGIN LABELING.

    Section 502 (21 U.S.C. 352) is amended by inserting at the end the 
following:
    ``(aa) If it is a drug in final dosage form or device for use on or 
by patients unless its label bears, and the Internet Web site of the 
manufacturer of the drug or device lists, 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 in the drug.''.

SEC. 116. EFFECTIVE DATE.

    This subtitle, and the amendments made by this subtitle, shall take 
effect on the date that is 180 days after the date of enactment of this 
Act.

           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 113, 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.

    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) Except as provided in subsection (g), 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--
            ``(1) all information submitted to U.S. Customs and Border 
        Protection in the entry declaration for such drug or such 
        article;
            ``(2) for a drug, or an article that appears to be a drug, 
        in finished dosage form--
                    ``(A) the listing number under section 510(e) of 
                such drug;
                    ``(B) the D-U-N-S number of each establishment in 
                which such drug was manufactured, prepared, propagated, 
                compounded, or processed;
                    ``(C) the new drug application number, the 
                abbreviated new drug application number, or the drug 
                monograph number, as applicable;
                    ``(D) the label required by the new drug 
                application, abbreviated new drug application, or drug 
                monograph, as applicable; and
                    ``(E) the record of inspections by the Secretary;
            ``(3) for an article that is an active ingredient of a 
        drug, or an article that is a precursor ingredient of an active 
        ingredient--
                    ``(A) the listing number under section 510(e) of 
                such article;
                    ``(B) the D-U-N-S number of each establishment in 
                which such article was manufactured, prepared, 
                propagated, compounded, or processed;
                    ``(C) the new drug application number, the 
                abbreviated new drug application number, or the drug 
                monograph number, as applicable, of the finished dosage 
                form for which such article is intended;
                    ``(D) the label under a regulatory exemption from 
                section 502(f)(1); and
                    ``(E) the record of inspections by the Secretary or 
                by a governmental authority responsible for drugs 
                deemed adequate by the Secretary; and
            ``(4) 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--
                    ``(A) the listing number under section 510(e) of 
                such article;
                    ``(B) the D-U-N-S number of each establishment in 
                which such article was manufactured, prepared, 
                propagated, compounded, or processed;
                    ``(C) the new drug application number, the 
                abbreviated new drug application number, or the drug 
                monograph number, as applicable, of the finished dosage 
                form for which such article is intended; and
                    ``(D)(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.''.

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

    Section 502 (21 U.S.C. 352), as amended by section 115, is further 
amended by adding at the end the following:
    ``(bb) 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 and reports.--The manufacturer of a drug 
        shall make and maintain records, and promptly submit reports to 
        the Secretary, about any defect of the drug.
            ``(2) 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.
            ``(3) 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 (2), 
        destroy the drug and shall not recondition the drug.
            ``(4) Defect.--For purposes of this subsection, a drug 
        shall be considered to have a defect if the manufacturer 
        rejects the drug for manufacturing or distribution because of--
                    ``(A) microbiological or other contamination;
                    ``(B) significant chemical, physical, or other 
                change or deterioration; or
                    ``(C) 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) 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 new drug application under section 
        505(b), an abbreviated new drug application under section 
        505(j), a biologics license application under section 351 of 
        the Public Health Service Act, an application for an 
        investigational new drug exemption under section 505(i), a new 
        animal drug application under section 512(b), an abbreviated 
        new animal drug application under section 512(b), an 
        application under section 571, a request under section 572, an 
        amendment, supplement, or other information submitted to the 
        Secretary with respect to any such application or request, or 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), 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 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;
                    ``(D) the information in such submission complies 
                with such requirements;
                    ``(E) the information in such submission 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) Responsible person.--A responsible person under this 
        section is, with respect to a submission described under 
        paragraph (1), a senior officer or director of the sponsor of 
        such submission with knowledge of, and management 
        responsibility for, such submission.
    ``(b) Inspections.--
            ``(1) In general.--If the Secretary determines, after 
        notice and opportunity for an informal hearing, that a sponsor 
        described in paragraph (2)(A) 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.--An application or report 
        for premarket approval under section 515, an application for an 
        investigational device exemption under section 520(g), a report 
        under section 510(k), an application for a humanitarian device 
        exemption under section 520(m), an amendment, supplement, or 
        other information submitted to the Secretary with respect to 
        any such application or report, or a record or report related 
        to an adverse event, a report, or postmarket surveillance under 
        section 519 or 522, 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;
                    ``(D) the information in such submission complies 
                with such requirements;
                    ``(E) the information in such submission 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) Responsible person.--A responsible person under this 
        section is, with respect to a submission described under 
        paragraph (1), a senior officer or director of the sponsor of 
        such submission with knowledge of, and management 
        responsibility for, such submission.
    ``(b) Inspections.--
            ``(1) In general.--If the Secretary determines, after 
        notice and opportunity for an informal hearing, that a sponsor 
        described in paragraph (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) an amendment, supplement, or other 
                        information submitted to the Secretary with 
                        respect to any application or request described 
                        in clauses (i) through (viii); or
                            ``(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; 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) an amendment, supplement, or other 
                        information submitted to the Secretary with 
                        respect to any application or report described 
                        in clauses (i) through (iv); or
                            ``(vi) a record or report related to an 
                        adverse event, a report, or postmarket 
                        surveillance under section 519 or 522 of such 
                        Act.''.
    (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.--No person that submits or is required to submit 
to the Secretary, a new drug application under section 505(b), an 
abbreviated new drug application under section 505(j), a biologics 
license application under section 351 of the Public Health Service Act, 
an application for an investigational new drug exemption under section 
505(i), a new animal drug application under section 512(b), an 
abbreviated new animal drug application under section 512(b), an 
application under section 571, a request under section 572, an 
application or report for premarket approval under section 515, an 
application for an investigational device exemption under section 
520(g), a report under section 510(k), an application for a 
humanitarian device exemption under section 520(m), an amendment, 
supplement, or other submission with respect to any such application or 
report, or 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, 
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--
            ``(1) 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 such section of this Act or such section 351 
        of the Public Health Service Act, 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--
                    ``(A) a Federal regulatory or law enforcement 
                agency;
                    ``(B) any Member of Congress or any committee of 
                Congress; or
                    ``(C) 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);
            ``(2) 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 such section of this Act or such section 351 
        of the Public Health Service Act, 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
            ``(3) to refuse to violate or assist in the violation of 
        any such section of this Act or such section 351 of the Public 
        Health Service Act, 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.
    ``(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.''.

 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>