[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6378 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 6378

 To expand the authority of the Secretary of Health and Human Services 
    to impose debarments in order to ensure the integrity of drug, 
   biological product, and device regulation, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 26, 2008

Mr. Barton of Texas (for himself, Mr. Deal of Georgia, Mr. Whitfield of 
 Kentucky, Mr. Shimkus, Mrs. Wilson of New Mexico, Mr. Pickering, Mrs. 
  Bono Mack, Mr. Walden of Oregon, Mr. Terry, Mr. Sullivan, and Mrs. 
  Blackburn) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To expand the authority of the Secretary of Health and Human Services 
    to impose debarments in order to ensure the integrity of drug, 
   biological product, and device regulation, 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 ``Strengthening of FDA Integrity Act 
of 2008''.

SEC. 2. DEBARMENT.

    (a) Application to Drugs, Biological Products, and Devices.--The 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended--
            (1) in section 201, by amending subsection (dd) to read as 
        follows:
    ``(dd) The term `drug product'--
            ``(1) for purposes of sections 306 and 307, means a drug 
        subject to regulation under section 505, 512, or 802 of this 
        Act or under section 351 of the Public Health Service Act; and
            ``(2) for purposes of section 306, includes a device 
        subject to regulation under section 513 of this Act.''; and
            (2) in section 306--
                    (A) by striking the term ``an abbreviated drug 
                application'' each place such term appears and 
                inserting ``a covered application'';
                    (B) by striking the terms ``abbreviated drug 
                application'' and ``abbreviated drug applications'' 
                each place either such term appears and inserting 
                ``covered application'' and ``covered applications'', 
                respectively;
                    (C) by striking the term ``drug product 
                application'' each place such term appears and 
                inserting ``covered application'';
                    (D) in the heading of subsections (a) and (b), by 
                striking ``Certain Drug Applications'' and inserting 
                ``Certain Drug Product Applications'';
                    (E) in subsection (b)(2)(B)(i), by striking ``the 
                process for the regulation of drugs'' and inserting 
                ``the process for the regulation of drug products'';
                    (F) in subsection (d)(4)(B)(ii), by striking ``of 
                any drug subject to sections 505'' and inserting ``of 
                any drug product'';
                    (G) in subsections (b)(2)(A), (b)(2)(B)(iv), 
                (c)(3)(C), (c)(3)(E), (d)(3)(A)(ii)(II), (d)(3)(B)(ii), 
                (d)(4)(B)(iv), (d)(4)(D)(ii), (f)(1)(B)(ii), (g), and 
                (h), by striking the terms ``drug'' and ``drugs'' each 
                place either such term appears and inserting ``drug 
                product'' and ``drug products'', respectively; and
                    (H) by adding at the end the following:
    ``(n) Covered Application Defined.--In this section, the term 
`covered application' means--
            ``(1) an application for approval or licensure of a drug 
        under section 505 of this Act or section 351 of the Public 
        Health Service Act, respectively; or
            ``(2) an application for clearance or approval of a device 
        under section 510(k) or 515 of this Act, respectively.''.
    (b) Mandatory Debarment.--Section 306(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 335a(a)) is amended--
            (1) by amending paragraph (1) to read as follows:
            ``(1) Corporations, partnerships, and associations.--If the 
        Secretary finds that a person other than an individual has been 
        convicted, after May 13, 1992, of a felony under Federal law 
        for conduct--
                    ``(A) relating to the development or approval, 
                including the process for development or approval, of 
                any drug product, or
                    ``(B) otherwise relating to the regulation of any 
                drug product under this Act or subpart 1 of part F of 
                title III of the Public Health Service Act,
        the Secretary shall debar such person from submitting, or 
        assisting in the submission of, any covered application.''; and
            (2) by adding at the end the following new paragraph:
            ``(3) Initiation of debarment.--The Secretary shall 
        initiate a debarment of a person or individual under paragraph 
        (1) or (2), respectively, not later than the date that is one 
        year after the date such person or individual is convicted of 
        the felony described in such respective paragraph.''.
    (c) Permissive Debarment.--Section 306(b)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 335a(b)(2)) is amended--
            (1) in subparagraph (A)(i), by amending subclause (I) to 
        read as follows:
                                    ``(I) relates to the development or 
                                approval, including the process for 
                                development or approval, of any drug 
                                product or otherwise relates to the 
                                regulation of drug products under this 
                                Act or subpart 1 of part F of title III 
                                of the Public Health Service Act, 
                                and'';
            (2) in subparagraph (B)--
                    (A) by striking clauses (ii) and (iii); and
                    (B) by redesignating clause (iv) as clause (ii); 
                and
            (3) by adding at the end the following:
                    ``(C) Bribery, fraud, and other such crimes.--Any 
                person (including any individual) whom the Secretary 
                finds has been convicted of--
                            ``(i) a felony which is not described in 
                        paragraph (1) or (2) of subsection (a) or in 
                        subparagraph (A) or (B)(i) of this subsection 
                        and which involves bribery, payment of illegal 
                        gratuities, fraud, perjury, false statement, 
                        racketeering, blackmail, extortion, 
                        falsification or destruction of records, or 
                        interference with or obstruction of an 
                        investigation into, or prosecution of, any 
                        criminal offense, or
                            ``(ii) a conspiracy to commit, or aiding or 
                        abetting such felony,
                if the Secretary finds, on the basis of the conviction 
                of such person and other information, that such person 
                has demonstrated a pattern of conduct sufficient to 
                find that there is reason to believe that such person 
                may violate requirements under this Act or subpart 1 of 
                part F of title III of the Public Health Service Act 
                relating to drug products.
                    ``(D) Material participation.--Any person 
                (including any individual) whom the Secretary finds 
                materially participated in acts that were the basis for 
                a conviction for an offense described in paragraph (1) 
                or (2) of subsection (a) or in subparagraph (A), 
                (B)(i), or (C) of this subsection for which a 
                conviction was obtained, if the Secretary finds, on the 
                basis of such participation and other information, that 
                such individual has demonstrated a pattern of conduct 
                sufficient to find that there is reason to believe that 
                such person may violate requirements under this Act or 
                subpart 1 of part F of title III of the Public Health 
                Service Act relating to drug products.''.
    (d) Additional Debarment Consideration.--Paragraph (3) of 
subsection (c) of section 306 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 335a(c)(3)) is amended--
            (1) by striking ``and'' at the end of subparagraph (E);
            (2) by striking the period at the end of subparagraph (F) 
        and inserting ``, and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(G) whether debarment of the person will affect 
                the public health because sufficient quantities of the 
                drug product would not be available.''.
    (e) Effective Dates.--Paragraph (2) of section 306(l) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)) is amended by 
striking the phrase ``occurred more than 5 years before'' each place 
such phrase appears and inserting ``occurred more than 1 year before''.
    (f) Annual Report.--Section 306 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 335a) is amended by adding at the end the 
following:
    ``(o) Annual Report.--Each year, the Secretary shall submit a 
report to the Congress on implementation of this section. Each such 
report shall identify--
            ``(1) debarment proceedings mandated under subsection (a) 
        or (m);
            ``(2) debarment proceedings initiated under subsection (a), 
        (b), or (m);
            ``(3) the status of debarment proceedings so initiated or 
        pending from a previous year;
            ``(4) debarments imposed under this section; and
            ``(5) debarments declined under this section.''.
    (g) Conforming Amendments.--Section 306 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 335a) is amended--
            (1) in subsections (a)(2)(B) and (h)(1)(A), by striking 
        ``this Act'' and inserting ``this Act or subpart 1 of part F of 
        title III of the Public Health Service Act'';
            (2) in subsection (b)(2)(A)(i)(II), by striking ``the date 
        of the enactment of this section'' and inserting ``May 13, 
        1992'';
            (3) in subsection (b)(4), by striking ``clause (iii) or 
        (iv) of paragraph (2)(B)'' and inserting ``subparagraph (B)(ii) 
        or (D) of paragraph (2)'';
            (4) in subsection (c)(1)(A), by striking ``subsection 
        (a)(1) or (b)(2)(A)'' and inserting ``subsection (a)(1) or 
        (b)(1)(A)'';
            (5) in subsection (c)(1)(B), by striking ``subsection 
        (a)(2) or (b)(2)(B)'' and inserting ``subsection (a)(2) or 
        (b)(1)(B)'';
            (6) in subsection (d)(3)(A)(i), by striking ``or paragraph 
        (2)(A) or (3) of subsection (b)'' and inserting ``subparagraph 
        (A) or (C) of subsection (b)(1)'';
            (7) in subsection (d)(3)(B)(i), by striking ``clause (i), 
        (ii), (iii), or (iv) of subsection (b)(2)(B) or subsection 
        (b)(3)'' and inserting ``subparagraph (B) or (C) of subsection 
        (b)(1)'';
            (8) in subsection (d)(3)(B)(ii), by striking ``under 
        subsection (b)(2)(B) or subsection (b)(3)'' and inserting 
        ``under subparagraph (B) or (C) of subsection (b)(1)'';
            (9) in subsection (j)(2), by striking ``clause (iii) or 
        (iv) of subsection (b)(2)(B)'' and inserting ``subparagraph 
        (B)(ii) or (D) of subsection (b)(2)''; and
            (10) in subsection (l)(2)--
                    (A) by striking ``clauses (i) and (ii) of 
                subsection (b)(2)(B)'' and inserting ``subparagraphs 
                (B)(i) and (C) of subsection (b)(2)'';
                    (B) by striking ``Clauses (iii) and (iv) of 
                subsection (b)(2)(B)'' and inserting ``Subparagraphs 
                (B)(ii) and (D) of subsection (b)(2)''; and
                    (C) by striking ``Clause (iv) of subsection 
                (b)(2)(B)'' and inserting ``Subparagraph (B)(ii) of 
                subsection (b)(2)''.
                                 <all>