[Congressional Record Volume 162, Number 59 (Monday, April 18, 2016)]
[Extensions of Remarks]
[Pages E499-E500]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]





    ADDING ZIKA VIRUS TO THE FDA PRIORITY REVIEW VOUCHER PROGRAM ACT

                                 ______
                                 

                               speech of

                        HON. FRANK PALLONE, JR.

                             of new jersey

                    in the house of representatives

                        Tuesday, April 12, 2016

  Mr. PALLONE. Mr. Speaker, I rise today in opposition to S. 2512, 
which would add Zika to the list of qualified tropical diseases under 
the Food and Drug Administration's Tropical Disease Priority Review 
Voucher Program. While I know that we would all agree that there is 
desperate need for a treatment for Zika, I do not believe that this 
legislation offers the solution that will help us to achieve that goal. 
Further, I am disappointed that this legislation has not had the 
benefit of any legislative action in our Committee where Members could 
discuss in greater detail the need for reforms to the currently flawed 
priority review voucher program.
  In 2007, Congress established the Tropical Disease Priority Review 
Voucher Program at FDA to incentivize treatments for neglected tropical 
diseases for which there was no market incentives to develop. Sponsors 
that develop a treatment for a qualified tropical disease are awarded a 
priority review voucher and have the option of retaining this voucher 
for a shortened review of another product in their development 
pipeline, or can sell the voucher to another company to use. Since 
enactment, three vouchers have been awarded under this program, two of 
which sold for $67 million and $125 million respectively. The value of 
the vouchers to sponsors has led to the development of the priority 
review voucher as a financial incentive in other areas, such as rare 
pediatric diseases.
  However, this program is not without flaws. Use of priority review 
vouchers is not limited to additional tropical disease products, 
meaning that companies can use this voucher for a review in six months 
of any product of its choosing. This can result in new drug 
applications receiving priority review that would not otherwise qualify 
if they do not treat a serious disease or condition, or offer a 
significant improvement in safety or effectiveness. In practice, this 
allows companies to ``purchase'' services from the agency at the 
expense of other important public health work, undermining FDA's 
mission and the morale of the agency's review staff. It also creates 
additional workload for the FDA by requiring a shortened review of 
applications for treatments that will be used in millions of patients 
and diverting review staff from other work. Finally, the additional 
priority review voucher fee associated with use of the voucher has not 
been effective in covering the full cost of the expedited review.
  In addition to effects on FDA, the current tropical disease priority 
review voucher program contains two additional flaws--eligibility for 
this program is not limited to novel therapies, nor are sponsors 
required to make the qualifying therapy available or accessible for 
those who are most in need. Two of the three priority review vouchers 
awarded under this program were awarded to therapies that were already 
in use in other countries prior to the program's establishment. Thus a 
voucher was awarded to sponsors without any new investment in tropical 
disease treatments. Similarly, patients and other organizations still 
struggle to access two of the three therapies awarded a priority review 
voucher either due to affordability or lack of availability. An award 
such as a priority review voucher should only be given to companies who 
are committed to making their therapy available to patients in disease-
endemic countries for which the program is intended to help.
  As we consider the bill before us today, it is important to note that 
FDA has the authority to add Zika to the tropical diseases program 
administratively if there is no significant market in developed nations 
for that disease and the disease disproportionately affects poor and 
marginalized populations. I will submit a letter from FDA noting that 
it is ``extremely unlikely that the Zika virus meets the criteria set 
out in the statute'' as there is a significant market for medical 
products for Zika virus currently. According to the agency, expanding 
the program to include Zika, which would be ineligible, would weaken 
the effectiveness of the priority review program and would create an 
undue burden on FDA.
  Mr. Speaker, it is for all of these reasons that I am opposing S. 
2512 today. It is clear there are significant issues with the tropical 
disease priority review voucher program that should have been discussed 
and considered as a part of the Committee process. Unfortunately, we 
were not afforded that opportunity. If the goal of the House is to 
address the Zika crisis, we should not be expanding a flawed program 
that will provide incentives for which there is no need. Instead 
Congress should be working together, including with the Administration, 
to fully fund a comprehensive response to Zika. I submit the following 
letter:

         Department of Health & Human Services, Food and Drug 
           Administration,
                             Silver Spring, MD, February 29, 2016.
       Dear Member: Thank you for your letter of February 05, 
     2016, urging the Food and Drug Administration (FDA or the 
     Agency) to add Zika virus to the list of qualified tropical 
     diseases under the Tropical Disease Priority Review Voucher 
     (PRV) Program by issuing an order, as authorized by the 
     Adding Ebola to the FDA Priority Review Program Act [PL 113-
     233].
       FDA is actively working on many fronts to help mitigate the 
     Zika virus outbreak. The Agency's primary areas of activity 
     include:
       (1) protecting the safety of the nation's blood supply and 
     ensuring the safety of cell and tissue products;
       (2) facilitating the development and availability of blood 
     donor screening and medical diagnostic tests for 
     identification of the presence of, or prior exposure to, Zika 
     virus;
       (3) supporting the development of investigational vaccines 
     and therapeutics;
       (4) reviewing proposals for the use of innovative 
     strategies to help suppress the population of virus-carrying 
     mosquitoes;
       (5) protecting the public from fraudulent products that 
     claim to prevent, diagnose, treat, or cure Zika virus 
     disease.
       Specific activities include issuing guidance to blood 
     collection centers on safeguards to prevent transfusion 
     transmission of Zika virus in areas of the U.S. and its 
     territories with active mosquito borne transmission 
     (currently Puerto Rico, U.S. Virgin Islands, American Samoa 
     and Marshall Islands), and in unaffected areas where the 
     virus might be introduced by persons returning from affected 
     areas. FDA is also developing guidance that will address 
     appropriate donor screening for human cells, tissues, and 
     cellular and tissue-based products: concerns in this area 
     have been highlighted by reported possible sexual 
     transmission of the Zika virus. FDA is reaching out to 
     potential commercial product manufacturers to encourage them 
     to develop and submit applications for emergency use of 
     diagnostic tests for the Zika virus. In addition, FDA is 
     actively engaged with the Office of the Assistant Secretary 
     for Preparedness and Response (ASPR), the Biomedical Advanced 
     Research and Development Authority (BARDA), the National 
     Institutes of Health (NIH), and the Centers for Disease 
     Control and Prevention (CDC) to advance the development of 
     diagnostic tests, vaccines, therapeutics, and donor screening 
     and pathogen-reduction technologies for blood products to 
     help mitigate this outbreak. These efforts have already 
     realized a major success. On February 26, 2016, under its 
     Emergency Use Authorization (EUA) authority, FDA authorized 
     the use of a Zika virus diagnostic test--developed by CDC--
     for the qualitative detection of Zika virus-specific 
     immunoglobulin M (IgM) antibodies by qualified laboratories. 
     This diagnostic test can help expand domestic readiness for 
     Zika virus by enabling the identification of patients 
     recently infected with Zika virus in support of response 
     efforts.
       As you are aware, under section 524 of the Federal Food, 
     Drug, and Cosmetic Act, the Secretary of Health and Human 
     Services is authorized to add infectious diseases to the list 
     of tropical diseases that would qualify the developer of a 
     licensed or approved product to prevent or treat an 
     identified tropical disease to receive a PRV under FDA's 
     Tropical Disease PRV Program, if: (1) there is no significant 
     market in developed nations for that disease; and (2) the 
     disease disproportionately affects poor and marginalized 
     populations. This authority is delegated to FDA.
       FDA has provided a process for requesting that additional 
     diseases be added to the PRV list through the submission of a 
     request to a special docket set up to facilitate the 
     consideration of such requests, accompanied by information to 
     document that the disease meets the statutory criteria 
     required to be added to the PRV list. While FDA has not 
     received a request to add the Zika virus to the PRV list via 
     the docket, the Agency does not want to foreclose anyone from 
     following that process and will evaluate any submissions that 
     are made with respect to the Zika virus. FDA wants to make it 
     clear, however, that--based on the information currently 
     available to FDA--it is extremely unlikely that the Zika 
     virus meets the criteria set out in the

[[Page E500]]

     statute. While it appears likely that the Zika virus 
     disproportionately affects poor and marginalized populations, 
     it also appears that there is a significant market for the 
     Zika virus medical products in developed nations, which would 
     render the Zika virus ineligible for addition to the PRV list 
     under the statute at this time.
       FDA agrees that we need to do all that we can to facilitate 
     the development of and access to medical products as quickly 
     as possible to respond to the Zika virus outbreak. We fully 
     believe that the incentives currently available for the Zika 
     product development--such as funding for research and 
     development, and clinical trial costs from government and 
     non-governmental organizations--as well as extensive HHS 
     technical assistance for product developers, are sufficient 
     to help bring Zika products to market. FDA is fully prepared 
     to use its authorities to the fullest extent appropriate--
     including proven mechanisms to speed the availability of 
     medical products for serious diseases--to help facilitate the 
     development and availability of products with the potential 
     to mitigate this outbreak as quickly as the science will 
     allow. However, expanding the PRV program by adding diseases 
     or conditions that do not meet the criteria for inclusion is 
     unnecessary, weakens the effectiveness of the PRV program, 
     and creates an undue burden on FDA that can ultimately harm 
     public health.
       As you are aware, the Administration has asked Congress for 
     approximately $1.9 billion in emergency funding to enhance 
     our ongoing efforts to prepare for and respond to the Zika 
     virus, both domestically and internationally. Approving this 
     funding request, which includes support for medical product 
     development and procurement, is essential for sustaining 
     HHS's effort to effectively incentivize the development and 
     availability of medical products for the Zika virus.
       Thank you, again, for contacting us concerning this matter. 
     If you have any questions or concerns, please do not hesitate 
     to contact me. The same letter has been sent to your 
     cosigners.
           Sincerely,

                                             Dayle Cristinzio,

                                 Acting Associate Commissioner for
     Legislation.

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