[Congressional Record Volume 164, Number 129 (Tuesday, July 31, 2018)]
[Senate]
[Pages S5472-S5474]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ANIMAL DRUG AND ANIMAL GENERIC DRUG USER FEE AMENDMENTS OF 2018
Mrs. MURRAY. Mr. President, in February, the HELP Committee passed a
bill to reauthorize the animal drug and animal generic drug user fee
programs at FDA. That bill was the result of months of bipartisan work.
During markup, we worked together to put aside differences and adopted
an amendment from Senator Murphy increasing innovation in animal drug
trial designs to advance more medicines for our pets and livestock--
similar to the work we did for humans in the 21st Century Cures Act--
and an amendment from Senator Paul to clarify the regulatory process
for animal feed additives.
We worked together because this bill has to pass by August 1 to avoid
disruption to the hard-working employees at FDA who ensure our pets and
food-producing animals have safe and effective drugs.
Last month, the House Energy and Commerce Committee took our
bipartisan bill that we worked on together and added a controversial
amendment that expands the conditional approval pathway for animal
drugs. Currently, the FDA can conditionally approve an animal drug for
a minor species or for an uncommon disease in a major species. This
narrow category of drugs can be approved, for a limited time, and sold
to customers while the company collects data to determine whether the
drug actually works. This pathway was supposed to spur innovation, but
only four drugs have ever been conditionally approved in the pathway's
14-year history, and only one of those four was actually effective and
gained full approval.
That is not a very good track record. Nonetheless, the House bill
expands that pathway to any difficult-to-develop animal drug that can
address an unmet need and doesn't even define what qualifies as
difficult.
I have been very concerned that the undefined scope of this pathway
sets a terrible precedent and, more importantly, doesn't uphold the
gold standard of FDA approval that our public relies on. However, today
Dr. Gottlieb has made public assurances to both me and our chairman
that he intends to implement this provision with additional caution and
restrictions, according to congressional intent.
FDA has committed to promulgating regulations to define what it means
for a study to be ``difficult.'' Importantly, FDA has publicly agreed
that conditional approval is not an appropriate pathway for any human
medical products or antibiotics.
Antibiotic resistance is a large and growing global public health
problem, and the rampant overuse of medically important antibiotics in
our food supply compounds that problem. I am very pleased this bill
requires FDA to report on its work to bring all medically important
antibiotics under veterinary supervision, but there is more to do.
I thank Senators Warren, Feinstein, Gillibrand, and Blumenthal for
their leadership on reducing the nonjudicious use of antibiotics in
animals. On Friday, Senator Warren sent a letter to FDA asking for
additional actions and commitments to bring all medically important
antibiotics under veterinary supervision and reevaluate duration limits
for antibiotic abuse.
I thank Mr. Gottlieb for his quick response to Senator Warren and his
clear commitment to work with us on these issues, including greater
transparency into the progress of removing unlimited durations of
antibiotic use. I sincerely hope we can avoid these situations in the
future, where deals struck between FDA and the industry, with little
transparency, are then somehow demanded of Congress.
Senator Alexander and I included language in this year's agricultural
appropriations bill that makes clear Congress does not find this
appropriate, and I hope the FDA and its regulated industries take that
language seriously in future user fee negotiations.
I support moving this bill forward today, but I do plan to conduct
careful oversight into the implementation of this law and hold FDA
accountable for any deviations from the commitments made to me today.
Mr. President, I ask unanimous consent that the letter addressed to
Senator Alexander and myself from Scott Gottlieb and Steve Solomon be
printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
U.S. Food & Drug Administration,
July 31, 2018.
Hon. Lamar Alexander, Chairman,
Hon. Patty Murray, Ranking Member,
Committee on Health, Education, Labor and Pensions, U.S.
Senate, Washington, DC.
Dear Chairman Alexander and Senator Murray: We are writing
to share with you the Food and Drug Administration's (FDA or
the Agency) current views on how it would implement the
proposed expanded conditional approval pathway in H.R. 5554,
the ``Animal Drug and Animal Generic Drug User Fee Amendments
of 2018.'' The Agency's staff were directed to review the
possibility of expanding the conditional approval pathway by
the previous reauthorization of the Animal Drug User Fee Act
(ADUFA) and Animal Generic Drug User Fee Act (AGDUFA)
programs in 2013, and we are prepared to implement the
expansion of the pathway as outlined in H.R. 5554, if
enacted, with appropriate regulatory caution and
restrictions.
FDA currently has conditional approval authority for animal
drugs intended to treat a minor species or for diseases or
conditions in major species that would constitute a minor
use, which was granted by the addition of section 571 to the
Federal Food, Drug, and Cosmetic Act (FD&C Act) in 2004 by
the Minor Use and Minor Species Animal Health Act (MUMS Act).
To receive conditional approval, an animal drug sponsor must
meet the same safety and manufacturing standards as a new
animal drug for which full approval is sought under section
512. The main advantage of the conditional approval pathway
for sponsors is that they can make their drug available after
demonstrating a reasonable expectation of effectiveness. The
pathway requires an annual review of the conditional approval
to determine if the sponsor is making sufficient progress
toward meeting the effectiveness standard for full approval.
FDA believes conditional approval offers a unique pathway
to address specific challenges of certain aspects of
veterinary medicine that human medicine does not face.
Therefore, FDA does not believe this pathway would be
suitable for human medical products. For example, variability
in response to therapies among animals means that one product
is not likely to meet the needs of all animals. Even within a
single species (e.g., canine), it is well-documented that
there can be significant variability among animal breeds in
how drugs are metabolized (e.g., ivermectin is toxic for
collies, but safe for other breeds). Despite the need,
incentivizing new product development continues to be a
challenge for the industry given the limited market for
veterinary drugs. Based on experience, we believe this
pathway would be used uncommonly, as a sponsor must make a
substantial investment of time and resources to obtain the
conditional approval. In addition, the sponsor
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must be confident that they will ultimately be successful in
meeting the substantial evidence of effectiveness standard
required for full approval under section 512(b). FDA's review
of its active pending animal drug products in various phases
of development indicates that 16 products might qualify for
the new pathway. FDA's best current estimate is that 12 to 20
animal drugs might seek conditional approval during the 10-
year authorization period provided in H.R. 5554.
FDA has acted to withdraw conditional approval when
sufficient progress towards meeting the effectiveness
standard for full approval has not been met. For example, FDA
withdrew the conditional approval of the drug Paccal Vet-CAI
in 2017, after it was conditionally approved in 2014, for
this reason. Since the MUMS Act was enacted in 2004, only
four drugs have received conditional approval, and FDA has
only granted a full new animal drug approval to one of these
drugs. We want to assure you that FDA will make certain there
are appropriately defined parameters for this expansion of
the conditional approval pathway, which will be developed
through a public process.
The proposed expansion of the pathway in H.R. 5554 would
allow certain animal drugs that are not intended to treat
minor species or minor uses in major species to qualify for
conditional approval, but only if they meet two key
requirements. The first proposed requirement is that the drug
must be ``intended to treat a serious or life-threatening
disease or condition or addresses an unmet animal or human
health need.'' FDA considers serious or life-threatening
diseases or conditions to be those that, if untreated, are
likely to lead to an animal's death, such as congestive heart
disease and lymphoma. FDA intends to define ``unmet need''
similarly to how the term is defined in FDA's Expedited
Programs guidance for human medical products. FDA intends to
provide more details to clearly define this first requirement
in the guidance or regulation it would be required to issue.
The second key requirement for eligibility would be that
``a demonstration of effectiveness would require a complex or
particularly difficult study or studies.'' FDA believes use
of the conditional approval pathway should and will be
limited to situations in which effectiveness is in fact
particularly difficult or complex to demonstrate, and would
only be granted after demonstrating a reasonable expectation
of effectiveness. FDA intends to consider whether the
clinical end-points of the disease or condition are
particularly difficult to evaluate. FDA also intends to
consider factors such as the need of a sponsor to use complex
adaptive or other novel investigation designs, real world
evidence, and the difficulty of enrolling trials. To clarify
the limited scope of new animal drug applications for which
this pathway would be available, FDA intends to issue
regulation to describe the elements it would consider in
determining whether an effectiveness study would be difficult
or complex to complete.
The proposed conditional approval expansion requires FDA to
issue guidance or regulation by September 30, 2019, to
clarify these criteria; FDA expects to finalize these
documents before accepting applications for the expanded
conditional approval pathway. We can assure you that FDA
believes this expanded pathway should be used only in very
limited cases, since its goal is to bring new veterinary
therapies to market for which there have not been sufficient
incentives to do so through the traditional new animal drug
approval pathway. FDA does not believe the age conditional
approval pathway should be available to new animal drugs that
easily could use the traditional new animal drug approval
pathway. If H.R. 5554 is enacted, we will keep your staff
closely updated on our efforts to clarify in guidance and
regulation the statutory restrictions on use of the expanded
conditional approval pathway.
H.R. 5554 also contains language that will provide Congress
the opportunity to reconsider conditional approval. The
proposed pathway will sunset after 10 years, to coincide with
the reauthorization of the user fee programs in 2028. In
addition, the language requires a Government Accountability
Office study to be completed prior to this date so that
Congress, the Agency, and stakeholders can evaluate the
expanded conditional approval pathway prior to its sunset.
The sunset provision would create an incentive for the Agency
and stakeholders to demonstrate that this pathway's
implementation is appropriately implemented and judiciously
utilized. Finally, H.R. 5554 further restricts this pathway
by prohibiting any drug that contains an active antimicrobial
ingredient from utilizing the expanded pathway.
In closing, we want to remind you that if H.R. 5554 is not
reauthorized before August 1, 2018, we must initiate the
process of adjusting animal drug review activities and the
personnel engaged in those activities, including identifying
and notifying 115 full time equivalent federal employee
positions of a reduction in force no later than 60 days prior
to their expected release. This could not only result in 115
full time employees being terminated, but would disrupt work
and morale--not only for hundreds of other employees at the
Agency's Center for Veterinary Medicine, but for their
colleagues in other Agency centers as well.
We hope that we have been able to alleviate any concerns
you have with the temporary, limited expansion of the
Agency's existing conditional approval pathway for animal
drugs in H.R. 5554, and that you will support timely passage
of this bill to avoid any reductions in force and disruptions
at the Agency. Again, you have our personal commitment to
keep your staff informed as we implement this provision, if
it is enacted.
Sincerely,
Scott Gottlieb, M.D.,
Commissioner of Food and Drugs.
Steve Solomon, D.V.M, M.P.H,
Director, Center for Veterinary Medicine.
The PRESIDING OFFICER. The Senator from Tennessee.
Mr. ALEXANDER. Mr. President, in a moment, I will specifically
address the comments the Senator from Washington made. First, I would
like to acknowledge that she and other Members of the Senate worked
with us to make sure this legislation could become law by August 1, and
I thank her for that.
Sometimes the House accepts a Senate bill, as it did with the Perkins
Career and Technical Education Act that the President signed today, and
sometimes the Senate accepts a House bill, as I will move that we do
today. One reason we are able to do that is because our committees work
closely with the House to try to take as many of their good ideas as we
can so we can pass each other's bill, if that became necessary. The
second reason that happens is because Senator Murray characteristically
works with me to solve problems like she is doing today, and I am
grateful to her for doing that. We don't agree on everything, but we
agree on a lot.
I noticed in our committee hearing the other day that the Committee
on Health, Education, Labor, and Pensions, of which I am chairman and
she is the ranking Democrat, has approved 50 bills this Congress.
Eighteen of them have been signed by the President. Some more will be
signed by the President.
We are working hard on opioids legislation, which is of great
interest to almost every Member of this body. Our committee has
unanimously reported that to the floor, and we are working with other
committees. We have been working with the House on that. We are working
on getting generic drugs to market more easily, something that has
needed to be done for 20 years. We have reported that out to the
Senate. Pandemic legislation--dealing with epidemics and being prepared
for them--is ready for the Senate to act on.
This is characteristic of the work Senator Murray and her staff do.
As she mentioned, this bill is the last of the so-called user fee
agreements. We passed four last August that dealt with about $9 billion
in industry user fees to fund the Food and Drug Administration. This is
another bill to do that. These bills are complicated and difficult and
involve lots of discussions. In the end, they often pass by agreement,
as this one will today, I believe, but that is because of the amount of
work our staff and Senator Murray's staff and the House of
Representatives have done. I thank them for that.
The FDA user fee bills provide about half the funding the Food and
Drug Administration uses every year to keep the drugs we buy at our
pharmacies and get at the doctor's office safe. We take it for granted,
but it is the gold standard, and we work very hard to try to make sure
we don't infringe on that gold standard of safety and efficacy.
The House of Representatives has passed, by unanimous consent, the
bill we referred to, the Animal Drug and Generic Animal Drug User Fee
Amendments, which reauthorizes user fee programs that allow the animal
drug industry and the Food and Drug Administration to continue to
expedite the review of safe and effective treatments for animals. These
updated agreements have been carefully worked out between the Food and
Drug Administration and the animal drug industry, with input from
farmers and ranchers, food and feed producers, veterinarians, and other
stakeholders.
If Congress doesn't do its job, as the Senator from Washington said,
to reauthorize these critical programs before August 1, the Food and
Drug Administration will be forced to send layoff notices to 115
employees. By our action today, we will be able to avoid that.
The review of over 2,000 animal drug applications and investigational
submissions currently pending before the Food and Drug Administration
will be significantly delayed if we don't act, and we intend to act.
This means it
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will take longer for new animal drugs and treatments to be available to
farmers, ranchers, veterinarians, and families, but, fortunately,
because of the cooperation today, that will not happen.
The Health, Education, Labor, and Pensions Committee, our committee,
approved the Senate version of this bill on February 28 of this year by
a bipartisan vote of 22 to 1. The bill passed the House in almost
identical form that was approved by the HELP Committee in February, but
the House bill, as Senator Murray said, expands conditional approval to
encourage innovation and competition.
Conditional approval allows a drug to go to market once it meets the
Food and Drug Administration safety standards, and then the drug
company has up to 5 years to prove the drug is effective. Based on
bipartisan feedback about conditional approval, the House of
Representatives agreed to make three changes in its bill: No. 1, a 10-
year sunset for conditional approval; No. 2, clarify the conditional
approval does not require an additional fee to be paid to the Food and
Drug Administration; and, No. 3, a Government Accountability Office
report on conditional approval.
Senator Murray and I agree that we need to clarify what it means for
a drug to be ``difficult to study.'' I have talked to Dr. Scott
Gottlieb, the Commissioner of the Food and Drug Administration about
these concerns, and he agrees. Dr. Gottlieb has agreed to quickly issue
guidance and develop regulations that provide clarity on what
``difficult to study'' means and that do not change the gold standard
of the Food and Drug Administration's drug approval process.
Also, conditional approval is not available for antimicrobial drugs.
The language in the bill is clear, and Dr. Gottlieb understands that
conditional approval is not available for antimicrobial drugs.
Congress will also conduct oversight to make sure conditional
approval is achieving the goal of helping more pets and keeping our
food supply safe. This bipartisan legislation will help keep animals
healthy, prevent disease outbreaks, and protect our food supply.
Mr. President, I ask unanimous consent that the Senate proceed to the
immediate consideration of H.R. 5554.
The PRESIDING OFFICER. The clerk will report the bill by title.
The legislative clerk read as follows:
A bill (H.R. 5554) to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize user fee programs relating to new
animal drugs and generic new animal drugs.
The PRESIDING OFFICER. Is there objection to proceeding to the
measure?
Without objection, notwithstanding rule XXII, the Senate will proceed
to the measure.
Mr. ALEXANDER. I ask unanimous consent that the bill be considered
read a third time.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered.
The bill was ordered to a third reading and was read the third time.
Mr. ALEXANDER. I know of no further debate on the bill.
The PRESIDING OFFICER. Is there further debate?
If not, the bill having been read the third time, the question is,
Shall the bill pass?
The bill (H.R. 5554) was passed.
Mr. ALEXANDER. I ask unanimous consent that the motion to reconsider
be considered made and laid upon the table.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. ALEXANDER. I yield the floor.
____________________