Adding Zika Virus to the FDA Priority Review Voucher Program Act

Floor Speech

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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 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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