ANIMAL DRUG AND ANIMAL GENERIC DRUG USER FEE AMENDMENTS OF 2018
(Senate - July 31, 2018)

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[Congressional Record Volume 164, Number 129 (Tuesday, July 31, 2018)]
[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

[[Page S5473]]

     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

[[Page S5474]]

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.

                          ____________________