I
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 deter-
mined 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 Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Pharmaceutical Re-
form Act of 2000’’.
SEC. 2. AMENDMENTS REGARDING ABBREVIATED APPLICA-
TIONS 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 para-
graph (1), and shall terminate any order under
such paragraph issued in response to the peti-
tion, if the Secretary determines that the per-
son submitting the petition received, as an in-
ducement 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 ingre-
dient.’’;
(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 fol-
lows 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 in-
serting ‘‘a certification and has been ap-
proved,’’; and
(ii) by amending subclause (I) to read
as follows:
‘‘(I) the date on which the Secretary ap-
proved the previous application,’’;
(D) in paragraph (7)(A)(i), in the matter
preceding subclause (I), by striking ‘‘the Sec-
retary shall publish’’ and inserting the fol-
lowing: ‘‘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 applica-
ble under this Act to the drug.
‘‘(B) Pursuant to subparagraph (A), no State or po-
litical subdivision of a State may establish or continue in
effect with respect to a drug approved under this sub-
section any prohibition against the use of the drug as a
substitute for any listed drug to which the drug is thera-
peutically equivalent as determined by the Secretary, in-
cluding therapeutic equivalence evaluated by the Secretary
as having an AB code (relating to actual or potential bio-
equivalence problems that have been resolved with ade-
quate 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