[House Report 116-572]
[From the U.S. Government Publishing Office]
116th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 116-572
======================================================================
FAIRNESS IN ORPHAN DRUG EXCLUSIVITY ACT
_______
November 16, 2020.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Pallone, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 4712]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 4712) 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, having
considered the same, reports favorably thereon with an
amendment and recommends that the bill as amended do pass.
CONTENTS
Page
I. Purpose and Summary............................................. 2
II. Background and Need for the Legislation........................ 3
III. Committee Hearings.............................................. 5
IV. Committee Consideration......................................... 6
V. Committee Votes................................................ 6
VI. Oversight Findings............................................. 6
VII. New Budget Authority, Entitlement Authority, and Tax Expenditur 6
VIII. Federal Mandates Statement..................................... 7
IX. Statement of General Performance Goals and Objectives.......... 7
X. Duplication of Federal Programs................................ 7
XI. Committee Cost Estimate........................................ 7
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.... 7
XIII. Advisory Committee Statement................................... 7
XIV. Applicability to Legislative Branch............................ 7
XV. Section-by-Section Analysis of the Legislation................. 7
XVI. Changes in Existing Law Made by the Bill, as Reported.......... 8
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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.
I. Purpose and Summary
H.R. 4712, the ``Fairness in Orphan Drug Exclusivity Act'',
was introduced by Representatives Madeleine Dean (D-PA), Earl
L. ``Buddy'' Carter (R-GA), Marc A. Veasey (D-TX), and David B.
McKinley (R-WV). H.R. 4712 updates the Orphan Drug Act to
require drug manufacturers seeking exclusive approval or
licensure for an orphan drug designated as such under section
526(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act
(FFDCA) to demonstrate the absence of any reasonable
expectation at the time of approval that the costs the
manufacturer incurs in developing the drug will be recovered in
the United States within twelve years of first marketing the
drug. The bill also requires drug manufacturers with active
orphan drug designations under section 526(a)(2)(B) of the
FFDCA at the time of enactment to make the same demonstration
no later than 60 days after enactment and would prohibit a drug
from receiving orphan drug exclusivity unless it met the
criteria for orphan drug designation on the date that the drug
was approved or licensed.
II. Background and Need for Legislation
The Orphan Drug Act was enacted in 1983 to incentivize the
development of drugs for rare diseases by providing
manufacturers with seven years of exclusive marketing rights
from date of approval, during which time the same drug produced
by another manufacturer is barred from entering the market.\1\
The Orphan Drug Act provides two ways under which the sponsor
of a drug application can receive an orphan drug designation:
(1) by being approved to treat a disease or condition that
affects 200,000 or fewer people, the most commonly used
``prevalence'' pathway; or (2) if there is no reasonable
expectation that the cost of developing a drug and making it
available in the United States will be recovered by U.S. sales,
the ``cost recovery'' pathway.\2\ A manufacturer may also
receive additional drug exclusivity periods for subsequently
approved drugs approved under the same orphan drug designation
(i.e. drugs made by the same manufacturer using the same active
moiety), regardless of whether the subsequent drugs meet the
original requirements of the orphan drug designation. This
provision in the law has allowed manufacturers to circumvent
the original intent of the Orphan Drug Act and blocked
competitors from the market despite evidence that the costs of
developing the subsequent drug could be recouped.
---------------------------------------------------------------------------
\1\Pub. L. No. 97-414.
\2\21 U.S.C. Sec. 360bb.
---------------------------------------------------------------------------
An illustrative example of this occurred in 2017, when
Sublocade, a buprenorphine drug manufactured by Indivior to
treat opioid use disorder, was approved under a 1994 orphan
drug designation for Subutex, a similar drug manufactured by
Reckitt Benckiser, the former parent company of Indivior.\3\
Subutex received its orphan drug designation using the cost
recovery pathway because, while opioid use disorder affected
more than 200,000 people, when the drug was designated as an
orphan drug in 1994, it was expected that buprenorphine would
only be prescribed in opioid treatment centers, limiting its
reach and U.S. sales, ultimately preventing the manufacturer
from recovering costs associated with developing the drug and
making it available.\4\ Six years later, however, the Drug
Addiction Treatment Act of 2000 (DATA 2000) allowed certain
qualifying physicians to prescribe buprenorphine outside of
opioid treatment programs, expanding access to the drug.\5\
From 2002 to 2011, buprenorphine treatments reached billions of
dollars in sales, including $285 million for Subutex, clearly
demonstrating that buprenorphine drugs could generate
sufficient sales to recover costs.\6\ Subsequent legislation,
including the Comprehensive Addiction Recovery Act of 2016
(CARA) again expanded access to buprenorphine, further raising
the potential for cost recovery and profitability.\7\
Nevertheless, in 2017, Sublocade, Indivior's follow-on
buprenorphine product, was granted orphan drug exclusivity
under Subutex's orphan drug designation.\8\ Raising concerns
that Sublocade was not a bona fide orphan drug (i.e., it did
not independently meet the requirements of either of the
prevalence or cost recovery pathways, and the drug was intended
to serve a large patient population of more than 2 million
individuals for which no additional orphan drug incentive was
necessary), and an orphan drug exclusivity period would limit
competition, Braeburn Inc., a generic drug manufacturer and
competitor to Indivior, filed a citizen petition with the Food
and Drug Administration (FDA) in 2019, arguing that the agency
should revoke the Sublocade's orphan drug designation.\9\ FDA
subsequently agreed with portions of the petition and revoked
the designation.\10\
---------------------------------------------------------------------------
\3\Kao-Ping Chua and Rena M. Conti, Orphan Drugs for Opioid Use
Disorder: An Abuse of the Orphan Drug Act, Health Affairs Blog, https:/
/www.healthaffairs.org/do/10.1377/hblog20190724.795814/full/ (July 26,
2019).
\4\Id.
\5\Enacted as part of the Children's Health Act of 2000, Pub. L.
No. 106-310.
\6\Kao-Ping Chua and Rena M. Conti, Orphan Drugs for Opioid Use
Disorder: An Abuse of the Orphan Drug Act, Health Affairs Blog, https:/
/www.healthaffairs.org/do/10.1377/hblog20190724.795814/full/ (July 26,
2019).
\7\Pub. L. No. 114-198; Pub. L. No. 115-271.
\8\Kao-Ping Chua and Rena M. Conti, Orphan Drugs for Opioid Use
Disorder: An Abuse of the Orphan Drug Act, Health Affairs Blog, https:/
/www.healthaffairs.org/do/10.1377/hblog20190724.795814/full/ (July 26,
2019).
\9\Citizen Petition Requesting FDA to Revoke Orphan Drug
Designation for Sublocade (Buprenorphine Extended-Release) Injection
for Treatment of Opiate Addiction in Opiate Users, Docket No. FDA-2019-
P-1697 (April 5, 2019).
\10\Letter from Lowell Schiller, FDA Principal Deputy Commissioner
for Policy, to Braeburn Inc. Re: Docket No. FDA-2019-P-1697 (Nov. 7,
2019).
---------------------------------------------------------------------------
H.R. 4712 will prevent a similar situation from happening
again, allowing for greater competition in the pharmaceutical
market and bringing down drug costs, while still preserving the
incentives enacted through the Orphan Drug Act to encourage the
development of treatments for rare diseases. To do this, the
bill prohibits the Secretary of the Department of Health and
Human Services (the Secretary) from granting orphan drug
exclusivity to drugs seeking designation under the cost
recovery pathway, unless the sponsor of the drug application
demonstrates that there is no reasonable expectation at the
time of approval or licensure that the cost of developing and
making the drug available in the United States will be
recovered from U.S. sales, taking into account all sales made
or reasonably expected to be made within twelve years of first
marketing the drug. Additionally, for drugs already approved or
licensed, H.R. 4712 requires manufacturers to, no later than 60
days after enactment, demonstrate that at the time of approval,
it was not reasonable to expect that costs would be recovered.
In the case that exclusive approval or licensure has already
been granted, recognized, or applied at the time of enactment,
H.R. 4712 would require the Secretary to revoke such
exclusivity unless these demonstrations were made. In
considering whether an orphan drug applicant has demonstrated
the absence of any reasonable expectation at the time of
approval that the costs incurred in developing the drug will be
recovered, the Secretary would be required to consider the
sales of all drugs that are developed or marketed by the same
sponsor or manufacturer of the drug, and are covered by the
same orphan drug designation. Furthermore, to prevent drugs
from receiving unwarranted orphan drug exclusivity based on an
earlier drug's orphan drug designation, H.R. 4712 prohibits a
drug from receiving orphan drug exclusivity unless it meets the
requirements for orphan drug designation on the day it was
approved or licensed. A rule of construction in H.R. 4712
applies these provisions to all drugs receiving an orphan drug
designation under the cost recovery pathway regardless of: (1)
the date on which it is designated or becomes the subject of a
designation request under such section; (2) the date on which
it is approved or licensed or the date on which the drug
becomes the subject of an application for approval or
licensure; and (3) the date on which the drug is granted
exclusive approval or licensure, or becomes the subject of an
application for approval or licensure.
Although there are no drugs that currently have orphan drug
exclusivity under the cost recovery pathway, H.R. 4712 is
necessary to prevent unwarranted exclusivity from being granted
in the future.
III. Committee Hearings
For the purposes of section 103(i) of H. Res. 6 of the
116th Congress, the following hearing was used to develop or
consider H.R. 4712:
The Subcommittee on Health held a legislative hearing on
January 29, 2020, entitled, ``Improving Safety and Transparency
in America's Food and Drugs.'' The hearing focused on H.R. 4712
and related legislation. The Subcommittee received testimony
from the following witnesses:
Panel I:
Jeff Allen, Ph.D., President and CEO,
Friends of Cancer Research
Richard Kaeser, Vice President, Global Brand
Protection, Johnson & Johnson
Fernando Muzzio, Ph.D., Distinguished
Professor, Chemical and Biochemical Engineering,
Rutgers, the State University of New Jersey
Kao-Ping Chua, M.D., Ph.D., Assistant
Professor, Department of Pediatrics, University of
Michigan Medical School
Panel II:
Melanie Benesh, Legislative Attorney,
Environmental Working Group
Tom Balmer, Executive Vice President,
National Milk Producers Federation
J. David Carlin, Senior Vice President of
Legislative Affairs and Economic Policy, International
Dairy Foods Association
Douglas Corey, D.V.M., Past President,
American Association of Equine Practitioners
Talia Day, Patient Advocate
Paul C. DeLeo, Ph.D., Principal, Integral
Consulting, Inc.
Mardi Mountford, President, Infant Nutrition
Council of America
Nancy Perry, Senior Vice President,
Government Relations, American Society for the
Prevention of Cruelty to Animals
Sara Sorscher, Deputy Director of Regulatory
Affairs, Center for Science in the Public Interest
IV. Committee Consideration
Representatives Dean, Carter (R-GA), Veasey, and McKinley
introduced H.R. 4712 on September 26, 2019, and the bill was
referred to the Committee on Energy and Commerce. Subsequently,
H.R. 4712 was referred to the Subcommittee on Health on
September 27, 2019. A legislative hearing was held on the bill
on January 29, 2020.
On March 11, 2020, the Subcommittee on Health met in open
markup session, pursuant to notice, to consider H.R. 4712.
During consideration of the bill, an amendment offered by Ms.
Eshoo (D-CA) was agreed to by a voice vote. Subsequently, the
Subcommittee on Health agreed to a motion offered by Ms. Eshoo,
Chairwoman of the subcommittee, to forward favorably H.R. 4712,
amended, to the full Committee on Energy and Commerce by a
voice vote.
On July 15, 2020, the full Committee met in virtual open
markup session, pursuant to notice, to consider a committee
print of the bill H.R. 4712, as amended by the Subcommittee on
Health on March 11, 2020. During consideration of the bill, a
manager's amendment offered by Mr. Veasey was agreed to by a
voice vote. Upon conclusion of consideration of the bill, the
full Committee agreed to a motion on final passage offered by
Mr. Pallone, Chairman of the committee, to order H.R. 4712
reported favorably to the House, amended, by a voice vote, a
quorum being present.
V. Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. The
Committee advises that there were no record votes taken on H.R.
4712, including the motion for final passage of the bill.
VI. Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1)
of rule X of the Rules of the House of Representatives, the
oversight findings and recommendations of the Committee are
reflected in the descriptive portion of the report.
VII. New Budget Authority, Entitlement Authority,
and Tax Expenditures
Pursuant to 3(c)(2) of rule XIII of the Rules of the House
of Representatives, the Committee adopts as its own the
estimate of new budget authority, entitlement authority, or tax
expenditures or revenues contained in the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974.
The Committee has requested but not received from the
Director of the Congressional Budget Office a statement as to
whether this bill contains any new budget authority, spending
authority, credit authority, or an increase or decrease in
revenues or tax expenditures.
VIII. Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
IX. Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to amend
the Federal Food, Drug, and Cosmetic Act with respect to
limitations on exclusive approval or licensure of orphan drugs.
X. Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 4712 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
XI. Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
XII. Earmarks, Limited Tax Benefits, and Limited
Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 4712 contains no earmarks, limited
tax benefits, or limited tariff benefits.
XIII. Advisory Committee Statement
No advisory committee within the meaning of section 5(b) of
the Federal Advisory Committee Act was created by this
legislation.
XIV. Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
XV. Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the short title may be cited as
the ``Fairness in Orphan Drug Exclusivity Act''.
Sec. 2. Limitations on exclusive approval or licensure of
orphan drugs
Section 2(a) states that under section 527 of the FFDCA the
Secretary may not grant, recognize, or apply orphan drug
exclusivity unless the sponsor of the drug application
demonstrates that there is no reasonable expectation at the
time of approval that the manufacturer would recover costs
incurred in developing or making the drug available in the
United States through sales within the United States within the
first twelve years of marketing the drug. In the case of a drug
for which exclusivity has been granted, recognized, or applied
prior to enactment, this section requires that the Secretary
revoke such exclusivity unless the manufacturer can make the
same demonstration within 60 days of enactment. When making
determinations regarding the sales of drugs and the ability to
recover costs, the Secretary would be required under section 2
to consider all drugs that are developed by the same sponsor or
manufacturer of the drug (or a licensor, predecessor in
interest, or other related entity to the sponsor or
manufacturer) that are covered under the same orphan drug
designation under section 526 of the FFDCA.
Section 2(a) also states that no drug receiving orphan drug
designation under section 526(a)(2)(B) (the ``cost recovery''
pathway) of the FFDCA shall be eligible for orphan drug
exclusivity unless it met the criteria of section 526(a)(2)(B)
on the date it was approved or licensed.
Finally, section 2(b) includes a rule of construction
applying the provisions of section 2(a) to any drug that has
been or will in the future be designated under section
526(a)(2)(B) of the FFDCA, regardless of--(1) the date on which
a drug is designated or becomes the subject of a designation
request under section 526; (2) the date on which a drug is
approved under section 505 of the FFDCA, licensed under section
351 of the Public Health Service Act or becomes the subject of
an application for such approval or licensure; and (3) the date
on which a drug is granted exclusive approval or licensure
under section 527 of the FFDCA or becomes the subject of a
request for such exclusive approval or licensure.
XVI. Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
* * * * * * *
Subchapter B--Drugs for Rare Diseases or Conditions
* * * * * * *
protection for drugs for rare diseases or conditions
Sec. 527. (a) [Except as provided in subsection (b)] Except
as provided in subsection (b) or (f), if the Secretary--
(1) approves an application filed pursuant to section
505, or
(2) issues a license under section 351 of the Public
Health Service Act
for a drug designated under section 526 for a rare disease or
condition, the Secretary may not approve another application
under section 505 or issue another license under section 351 of
the Public Health Service Act for the same drug for the same
disease or condition for a person who is not the holder of such
approved application or of such license until the expiration of
seven years from the date of the approval of the approved
application or the issuance of the license. Section 505(c)(2)
does not apply to the refusal to approve an application under
the preceding sentence.
(b) During the 7-year period described in subsection (a) for
an approved application under section 505 or license under
section 351 of the Public Health Service Act, the Secretary may
approve an application or issue a license for a drug that is
otherwise the same, as determined by the Secretary, as the
already approved drug for the same rare disease or condition
if--
(1) the Secretary finds, after providing the holder
of exclusive approval or licensure notice and
opportunity for the submission of views, that during
such period the holder of the exclusive approval or
licensure cannot ensure the availability of sufficient
quantities of the drug to meet the needs of persons
with the disease or condition for which the drug was
designated; or
(2) the holder provides the Secretary in writing the
consent of such holder for the approval of other
applications or the issuance of other licenses before
the expiration of such seven-year period.
(c) Condition of Clinical Superiority.--
(1) In general.--If a sponsor of a drug that is
designated under section 526 and is otherwise the same,
as determined by the Secretary, as an already approved
or licensed drug is seeking exclusive approval or
exclusive licensure described in subsection (a) for the
same rare disease or condition as the already approved
drug, the Secretary shall require such sponsor, as a
condition of such exclusive approval or licensure, to
demonstrate that such drug is clinically superior to
any already approved or licensed drug that is the same
drug.
(2) Definition.--For purposes of paragraph (1), the
term ``clinically superior'' with respect to a drug
means that the drug provides a significant therapeutic
advantage over and above an already approved or
licensed drug in terms of greater efficacy, greater
safety, or by providing a major contribution to patient
care.
(d) Regulations.--The Secretary may promulgate regulations
for the implementation of subsection (c). Beginning on the date
of enactment of the FDA Reauthorization Act of 2017, until such
time as the Secretary promulgates regulations in accordance
with this subsection, the Secretary may apply any definitions
set forth in regulations that were promulgated prior to such
date of enactment, to the extent such definitions are not
inconsistent with the terms of this section, as amended by such
Act.
(e) Demonstration of Clinical Superiority Standard.--To
assist sponsors in demonstrating clinical superiority as
described in subsection (c), the Secretary--
(1) upon the designation of any drug under section
526, shall notify the sponsor of such drug in writing
of the basis for the designation, including, as
applicable, any plausible hypothesis offered by the
sponsor and relied upon by the Secretary that the drug
is clinically superior to a previously approved drug;
and
(2) upon granting exclusive approval or licensure
under subsection (a) on the basis of a demonstration of
clinical superiority as described in subsection (c),
shall publish a summary of the clinical superiority
findings.
(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.
* * * * * * *
[all]