[Congressional Record Volume 167, Number 81 (Tuesday, May 11, 2021)]
[House]
[Pages H2181-H2183]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FAIRNESS IN ORPHAN DRUG EXCLUSIVITY ACT
Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the
bill (H.R. 1629) 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.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 1629
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
[[Page H2182]]
(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.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Kentucky (Mr. Guthrie) each
will control 20 minutes.
The Chair recognizes the gentleman from New Jersey.
General Leave
Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on H.R. 1629.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Madam Speaker, I yield myself such time as I may
consume.
I rise in support of H.R. 1629, the Fairness in Orphan Drug
Exclusivity Act. The legislation will close a loophole in the orphan
drug program to ensure generic drugs can come to market and are not
unfairly blocked by their brand competitors.
This bill, which passed the House by a voice vote last Congress,
takes steps to address two crises: one, the soaring cost of
prescription drugs; and, two, the ongoing opioid crisis. It deserves
our bipartisan support once again today.
The Orphan Drug Act has been successful in driving research and
discovery of new therapies to treat and even cure rare diseases. The
law incentivizes the development of these therapies, including by
awarding 7 years of market exclusivity and two pathways for
manufacturers to receive these incentives.
Under the first pathway, orphan drug status may be awarded when
manufacturers develop drugs approved to treat diseases with patient
populations of 200,000 or fewer. Under the second pathway, through the
rarely used cost recovery pathway, they may receive orphan drug status
if drug research and development costs are not expected to be recouped
by sales of the underlying drug.
Now, under certain circumstances, a manufacturer may also get
additional rounds of exclusivity for additional drugs in their
portfolio if they treat the same condition and have the same active
ingredient, even if the second drug does not meet the orphan drug
qualifications. This provision has allowed some manufacturers to
circumvent the original intent of the Orphan Drug Act, which was to
incentivize the creation of novel drugs for small populations.
Because of this loophole, some manufacturers have been able to market
widely used drugs to large populations, all while retaining exclusivity
and blocking generic competition from coming to market.
An example of this recently occurred when a formulation of bupe, a
drug to treat opioid use disorder, was approved in 2017 and was allowed
to carry the orphan drug designation granted to its manufacturer's
original bupe drug more than 20 years earlier in 1994.
When the original 1994 orphan drug designation was granted, it was
expected that this drug would not be prescribed frequently. However, as
the opioid crisis worsened, and our response to the crisis evolved,
millions were eventually prescribed the treatment, generating billions
in sales.
Clearly, we knew in 2017 that bupe was not an orphan drug.
Nevertheless, the drug was granted orphan drug status and exclusivity,
and that delayed additional forms of generic competition.
While the FDA eventually recognized this issue with this particular
drug and revoked its orphan drug designation, its exclusivity delayed
generic competition that otherwise would have been on the market.
We need, Madam Speaker, every tool available to us to combat the
opioid epidemic, including low-cost, affordable medication treatments,
and loopholes like this one should not be allowed to limit access to
low-cost drugs.
H.R. 1629 would stop this from happening again in the future. It
requires drug manufacturers to demonstrate in their application to the
FDA that each drug application considered under the cost recovery
pathway would fail to recoup development costs. The legislation would
also ensure that these rules apply to drugs already on the market.
This bill is a narrowly tailored fix for a narrow but very real
loophole in the law. I thank Representative Dean from Pennsylvania for
introducing this bill. It passed the House on a bipartisan basis, by
voice vote, and without opposition last Congress. I look forward to it
passing with bipartisan support again today and getting it through the
Senate and to President Biden's desk so it can become law. I urge all
of my colleagues to support the bill.
Madam Speaker, I reserve the balance of my time.
Mr. GUTHRIE. Madam Speaker, I yield myself such time as I may
consume.
Madam Speaker, I rise today in support of the Fairness in Orphan Drug
Exclusivity Act.
The Orphan Drug Act was enacted to incentivize the development of
drugs for rare diseases by giving products that receive an orphan drug
designation 7 years of market exclusivity, meaning a drug produced by
another manufacturer that contains the same active ingredient to treat
the same condition is barred from entering the market during this time.
One way a drug can receive an orphan designation and, subsequently,
market exclusivity is by the manufacturer's demonstration that there is
no reasonable expectation that the cost of developing the drug will be
recovered. However, we have seen in recent years that some drug
manufacturers, in an effort to block competitors from the market, have
tried to take advantage of a loophole in the law. Existing law allows
an orphan drug designation and market exclusivity to carry forward to
future versions of the same drug without requiring the manufacturer to
demonstrate that the drug has not been, and remains unlikely to be,
profitable.
This legislation will close that loophole, requiring manufacturers to
show there is no reasonable expectation that the cost of research and
development will be covered for each successor drug, while still
preserving incentives for orphan drug development.
We must preserve incentives to innovate while preventing bad actors
from exploiting those incentives to benefit from a national crisis, as
we saw during the opioid epidemic.
While no drug currently benefits from market exclusivity awarded
through this mechanism, I remain concerned about including language
that allows for the retroactive revocation of an incentive through
legislation.
Legislation that sets a precedent of revoking a benefit awarded prior
to enactment creates a slippery slope and could chill innovation if
adopted elsewhere in statute. While this bill itself is narrowly
tailored, we do not want uncertainty caused by Congress retroactively
legislating to discourage truly innovative drugs from coming to the
[[Page H2183]]
market, especially for the rare disease community.
However, I will support this bill as it moves forward today as I
believe it is important to prevent the abuse of this program in the
future. I look forward to continuing discussions to come to a
resolution on this outstanding concern as we work with the Senate to
get this bill to the President's desk.
Madam Speaker, I reserve the balance of my time.
Mr. PALLONE. Madam Speaker, I yield such time as she may consume to
the gentlewoman from Pennsylvania (Ms. Dean), the author of this
legislation, which is important because whenever we can encourage
generics and make drugs more affordable, it is certainly to the benefit
of the American people.
{time} 1615
Ms. DEAN. Madam Speaker, I thank Representative Guthrie and Chairman
Pallone for their support of this critical legislation.
Madam Speaker, I rise in support of H.R. 1629, the Fairness in Orphan
Drug Exclusivity Act.
This crucial legislation would close a loophole in the current law
that can be used to block competition in the pharmaceutical
marketplace.
The Orphan Drug Act of 1983 provided incentives for prescription drug
manufacturers to develop products to treat rare diseases. This includes
an exclusive 7-year marketing right for therapies that receive an
orphan drug designation.
For a drug to qualify, it must either be a treatment for a disease or
a condition that affects fewer than 200,000 people in the United
States, or is a drug intended for diseases that there is no reasonable
expectation to recoup research and development costs.
This legislation focuses on the drugs intended for diseases that
there is no reasonable expectation to recoup research and development
costs. It would require all drug manufacturers who obtain orphan drug
status to prove that they have no reasonable expectation that they will
recover their research and development costs and efforts.
This legislation works to prevent companies from continuing to use
orphan drug exclusivity status for a newly approved drug, with an
identical ingredient to the former version, without having to prove the
inability to recoup costs.
This exact circumstance happened when a manufacturer of a
buprenorphine product updated an older product that received orphan
drug status and subsequently was given a renewed orphan drug
exclusivity. Buprenorphine is used as a treatment for opioid use
disorder to help those recovering from addiction. Unfortunately, at the
time, the opioid epidemic was raging. It was, by no means, a rare
disease, and the drug was not a market loser.
Closing this loophole will ensure that products do not receive an
unfair market advantage and, therefore, remains consistent with the
spirit and intent of the Orphan Drug Act. We must work to ensure people
can gain access to newer therapies and medically assisted treatments
that are potentially blocked due to orphan designation.
Madam Speaker, I thank Representative Marc Veasey for introducing
this legislation along with me. I thank my colleagues in the House for
passing this bill without objection on a voice vote just 6 months ago
in the 116th Congress.
Again, I thank Chairman Pallone for bringing this bill forward and
for his leadership on substance use disorder and behavioral health
issues more broadly.
Madam Speaker, I urge Members to support this bill.
Mr. GUTHRIE. Madam Speaker, I yield myself such time as I may consume
for the purpose of closing.
Madam Speaker, it is so important that we have the Orphan Drug Act.
We have so many people who have rare diseases come to our offices and
visit us on Capitol Hill, as they should. Hopefully we will be able to
do that again soon. It just touches your heart. Many of these diseases
have so few people affected by it; but if it is you or your child or
somebody in your family, it is devastating.
We have all seen the power of the private marketplace to come in and
produce these pharmaceuticals that make a difference. So we have to
have provisions to allow these drugs to come into the marketplace and
incentivize that private innovation moving forward.
But when people use that in order to move forward, this loophole has
to be closed. I am glad that it is here, and it is these things that we
need to work on. It is really not specifically here; it is just maybe a
slippery slope in other places as we move forward.
I thank my friend from Pennsylvania for bringing this forward, and
the Energy and Commerce Committee for addressing this, because we have
to preserve orphan drug status for those afflicted by the rarest and
the most devastating diseases. We also need to bring lower drug prices
to Americans, and we can do that working together.
Madam Speaker, I appreciate this being brought forward. I urge my
colleagues to support this piece of legislation, and I yield back the
balance of my time.
Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume
for the purpose of closing.
Madam Speaker, I thank Representative Guthrie for his remarks about
trying to work together to lower the cost of prescription drugs. I
thank Congresswoman Dean because this is a part of that effort.
As you will note, today, we had a whole package dealing with mental
health, behavioral health, and other drug activities. It is very
important that we move this whole package and try to get it passed in
the Senate as quickly as possible.
Madam Speaker, I urge support for this legislation on a bipartisan
basis, and I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from New Jersey (Mr. Pallone) that the House suspend the
rules and pass the bill, H.R. 1629.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. GUTHRIE. Madam Speaker, on that I demand the yeas and nays.
The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution
8, the yeas and nays are ordered.
Pursuant to clause 8 of rule XX, further proceedings on this motion
are postponed.
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