Prohibits a patent from being considered to claim a listed drug unless, with respect to such drug, the patent claims an active ingredient.
Provides the effective date of the approval of an abbreviated application for a new drug containing a certification that its patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.
Prohibits any State or political subdivision from: (1) taking any action with respect to a drug approved under such Act that is different from or in addition to any listed requirement; or (2) establishing or continuing in effect a prohibition against the use of a drug as a substitute for any listed drug to which the drug is therapeutically equivalent.
Expresses the sense of Congress that a specified provision of the Public Health Service Act authorizes the submission of an abbreviated application for the approval of a new drug that is a biological product.
[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>
Introduced in House
Introduced in House
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.
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.
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.
Referred to the Subcommittee on Courts and Intellectual Property.
Referred to the Subcommittee on Health and Environment.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line