[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1629 Referred in Senate (RFS)]
<DOC>
117th CONGRESS
1st Session
H. R. 1629
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 20, 2021
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act with respect to
limitations on exclusive approval or licensure of orphan drugs, 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 ``Fairness in Orphan Drug Exclusivity
Act''.
SEC. 2. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICENSURE OF ORPHAN DRUGS.
(a) In General.--Section 527 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360cc) is amended--
(1) in subsection (a), by striking ``Except as provided in
subsection (b)'' and inserting ``Except as provided in
subsection (b) or (f)''; and
(2) by adding at the end the following:
``(f) Limitations on Exclusive Approval, Certification, or
License.--
``(1) In general.--For a drug designated under section 526
for a rare disease or condition pursuant to the criteria set
forth in subsection (a)(2)(B) of such section, the Secretary
shall not grant, recognize, or apply exclusive approval or
licensure under subsection (a), and, if such exclusive approval
or licensure has been granted, recognized, or applied, shall
revoke such exclusive approval or licensure, unless the sponsor
of the application for such drug demonstrates--
``(A) with respect to an application approved or a
license issued after the date of enactment of this
subsection, upon such approval or issuance, that there
is no reasonable expectation at the time of such
approval or issuance that the cost of developing and
making available in the United States such drug for
such disease or condition will be recovered from sales
in the United States of such drug, taking into account
all sales made or reasonably expected to be made within
12 years of first marketing the drug; or
``(B) with respect to an application approved or a
license issued on or prior to the date of enactment of
this subsection, not later than 60 days after such date
of enactment, that there was no reasonable expectation
at the time of such approval or issuance that the cost
of developing and making available in the United States
such drug for such disease or condition would be
recovered from sales in the United States of such drug,
taking into account all sales made or reasonably
expected to be made within 12 years of first marketing
the drug.
``(2) Considerations.--For purposes of subparagraphs (A)
and (B) of paragraph (1), the Secretary and the sponsor of the
application for the drug designated for a rare disease or
condition described in such paragraph shall consider sales from
all drugs that--
``(A) are developed or marketed by the same sponsor
or manufacturer of the drug (or a licensor, predecessor
in interest, or other related entity to the sponsor or
manufacturer); and
``(B) are covered by the same designation under
section 526.
``(3) Criteria.--No drug designated under section 526 for a
rare disease or condition pursuant to the criteria set forth in
subsection (a)(2)(B) of such section shall be eligible for
exclusive approval or licensure under this section unless it
met such criteria under such subsection on the date on which
the drug was approved or licensed.''.
(b) Rule of Construction.--The amendments made in subsection (a)
shall apply to any drug that has been or is hereafter designated under
section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bb) for a rare disease or condition pursuant to the criteria under
subsection (a)(2)(B) of such section regardless of--
(1) the date on which such drug is designated or becomes
the subject of a designation request under such section;
(2) the date on which such drug is approved under section
505 of such Act (21 U.S.C. 355) or licensed under section 351
of the Public Health Service Act (42 U.S.C. 262) or becomes the
subject of an application for such approval or licensure; and
(3) the date on which such drug is granted exclusive
approval or licensure under section 527 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360cc) or becomes the subject
of a request for such exclusive approval or licensure.
SEC. 3. DETERMINATION OF BUDGETARY EFFECTS.
The budgetary effects of this Act, for the purpose of complying
with the Statutory Pay-As-You-Go Act of 2010, shall be determined by
reference to the latest statement titled ``Budgetary Effects of PAYGO
Legislation'' for this Act, submitted for printing in the Congressional
Record by the Chairman of the House Budget Committee, provided that
such statement has been submitted prior to the vote on passage.
Passed the House of Representatives May 19, 2021.
Attest:
CHERYL L. JOHNSON,
Clerk.