[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5231 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 5231

To amend the Federal Food, Drug, and Cosmetic Act and title 35, United 
States Code, with respect to abbreviated applications for the approval 
                             of new drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 20, 2000

  Mr. Mollohan (for himself and Mr. Calvert) introduced the following 
bill; which was referred to the Committee on Commerce, and in addition 
  to the Committee on the Judiciary, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act and title 35, United 
States Code, with respect to abbreviated applications for the approval 
                             of new drugs.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmaceutical Reform Act of 2000''.

SEC. 2. AMENDMENTS REGARDING ABBREVIATED APPLICATIONS FOR APPROVAL OF 
              NEW DRUGS.

    (a) Federal Food, Drug, and Cosmetic Act.--The Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
            (1) in section 306(f), by adding at the end the following 
        paragraph:
                    ``(4) Limitation.--The Secretary shall cease 
                consideration of a petition under paragraph (1), and 
                shall terminate any order under such paragraph issued 
                in response to the petition, if the Secretary 
                determines that the person submitting the petition 
                received, as an inducement for submitting the petition, 
                valuable consideration provided directly or indirectly 
                by an entity any of whose financial interests are 
                served by the issuance of an order under such 
                paragraph.''; and
            (2) in section 505(j)--
                    (A) in paragraph (2), by adding at the end the 
                following subparagraph:
    ``(D) For purposes of subparagraph (A)(vii), a patent may not be 
considered to claim a listed drug unless with respect to such drug the 
patent claims an active ingredient.'';
                    (B) in paragraph (5)(B)(iii), in the second 
                sentence, in the matter preceding subclause (I), by 
                striking ``If such an action'' and all that follows 
                through ``, except that'' and inserting the following: 
                ``If such an action is brought before the expiration of 
                such days, the approval shall be made effective upon 
                the expiration of such period as the court may 
                designate, consistent with chapters 28 and 29 of title 
                35, United States Code, and taking into account whether 
                the parties to the action reasonably cooperate in 
                expediting the action (which period shall begin on the 
                date of the receipt of the notice provided under 
                paragraph (2)(B)(i)), except that'';
                    (C) in paragraph (5)(B)(iv)--
                            (i) in the matter preceding subclause (I), 
                        by striking ``a certification,'' and inserting 
                        ``a certification and has been approved,''; and
                            (ii) by amending subclause (I) to read as 
                        follows:
                    ``(I) the date on which the Secretary approved the 
                previous application,'';
                    (D) in paragraph (7)(A)(i), in the matter preceding 
                subclause (I), by striking ``the Secretary shall 
                publish'' and inserting the following: ``the Secretary, 
                in consultation with the Commissioner of Patents and 
                Trademarks, shall publish''; and
                    (E) by adding at the end the following paragraph:
    ``(10)(A) No State or political subdivision of a State may 
establish or continue in effect with respect to a drug approved under 
this subsection any requirement that is different from, or in addition 
to, any requirement applicable under this Act to the drug.
    ``(B) Pursuant to subparagraph (A), no State or political 
subdivision of a State may establish or continue in effect with respect 
to a drug approved under this subsection any prohibition against the 
use of the drug as a substitute for any listed drug to which the drug 
is therapeutically equivalent as determined by the Secretary, including 
therapeutic equivalence evaluated by the Secretary as having an AB code 
(relating to actual or potential bioequivalence problems that have been 
resolved with adequate evidence that supports bioequivalence).''.
    (b) Title 35, United States Code.--Section 271(e)(1) of title 35, 
United States Code, is amended by striking ``a Federal law which 
regulates'' and inserting the following: ``a Federal law, or a law of a 
foreign country, which regulates''.
    (c) Sense of Congress.--It is the sense of the Congress that 
section 351(j) of the Public Health Service Act (as added by section 
123(g) of the Food and Drug Administration Modernization Act of 1997; 
111 Stat. 2324) authorizes the submission, under section 505(j) of the 
Federal Food, Drug, and Cosmetic Act, of an abbreviated application for 
the approval of a new drug that is a biological product.
                                 <all>