DearColleague.us

Letter

From: The Honorable Susan W. Brooks
Sent By: helen.dwight@mail.house.gov
Date: 1/29/2016

PROTECT AMERICANS FROM ZIKA VIRUS OUTBREAK
Letter closes COB Tuesday, February 2nd.
Dear Colleague,
Please join me in sending a letter to Acting Administrator Ostroff of the Food and Drug Administration (FDA) encouraging FDA to exercise their authority and add the Zika virus to the FDA Tropical Disease Priority Review Voucher (PRV) Program.
On Thursday, the World Health Organization categorized the Zika virus outbreak as “spreading explosively” in the Americas and announced that an emergency meeting would be convened on Monday to determine if the outbreak should be declared a public health emergency. The outbreak of Zika virus has already spread to 21 South American countries, and resulted in the infection of more than 30 Americans who travelled to impacted areas. If we don’t act now, Zika could continue to spread across the Americas. Current estimates from WHO indicate an infection rate of three million to four million people a year in the Americas, and that number does not include the unborn infants at risk of infection and brain damage in the womb. That’s why it’s important that FDA quickly exercise their authority to add Zika to the FDA Priority Review Voucher Program
A priority review voucher (PRV) allows the developer of a treatment for a neglected or rare disease a special voucher which allows the developer to have any one of their drugs reviewed in an expedited manner. In 2007, Congress authorized FDA to award PRVs to sponsors of neglected tropical disease products, including tuberculosis, malaria, and cholera. At that time, Congress identified a total of 16 neglected tropical diseases that were eligible for these vouchers. The incentive has worked: numerous companies expanded research into these diseases and three vouchers have been awarded for products receiving FDA approval.
In 2014, Congress passed the “Adding Ebola to the FDA Priority Review Voucher Program Act” which granted FDA the authority to add other tropical disease to the PRV list, should they meet specific criteria. Since the law’s passage, FDA has exercised this authority twice, and it is imperative that FDA once again act on this authority, incentivizing research and development into vaccines and treatments for the disease. As the Administration and top U.S. health officials convene to tackle this issue, it is important that FDA act on its authority and promptly add Zika to the list of diseases eligible for PRVs.
Given the recent warning from the WHO at Zika virus is “spreading explosively”, FDA must act now. Please contact Helen Dwight in my office (helen.dwight@mail.house.gov) with any questions or to sign this letter. The letter closes COB on Tuesday, February 2nd.
Sincerely,
Susan W. Brooks
Member of Congress

 

 

February XX, 2016
Stephen Ostroff, M.D.
Acting Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Dr. Ostroff:
On January 26, 2016, President Obama called for the rapid development of tests, vaccines and treatments to fight the mosquito-transmitted Zika virus and the need to develop vaccines and therapeutics. To fulfill this goal, we believe that it is vital that the FDA exercise its statutory authority by adding Zika to the FDA Tropical Disease Priority Review Voucher Program.
As you know, before Congress passed the “Adding Ebola to the FDA Priority Review Voucher Program Act” (P.L. 113-233) in 2014, Ebola was not listed in statute as a qualifying tropical disease. In addition to adding Filoviruses to the list of qualified tropical diseases, the new law provided the Food and Drug Administration (FDA) more flexibility to add diseases to the qualifying list by issuing an order instead of a regulation. This flexibility was intended to eliminate unnecessary delays in offering appropriate incentives for companies to develop treatments for neglected tropical diseases that are emerging as new public health threats.
Unfortunately, today we are witnessing the spread of another tropical disease threatening the health of U.S. citizens. The Zika virus, spread primarily through mosquitos and first detected decades ago in Uganda, has now begun to spread rapidly in South America. The recent outbreak has been linked with serious neurological disorders and life-threatening birth defects.
On January 28, 2016, the World Health Organization (WHO) reported that Zika is “spreading explosively” throughout the Americas and will likely reach North America soon. The WHO found that as of today, cases have been reported in 23 countries in the region and that as many as four million people could be infected by the end of the year. WHO is concerned about this rapidly spreading disease due to the lack of immunity in newly affected areas, the wide geographical distribution of infected mosquitos, and the absence of any vaccines, treatments, or rapid diagnostic tests.
Given the lack of treatments available for Zika virus, we believe it is critical that FDA use its authority to add Zika to the list of Neglected Tropical Diseases eligible for the Priority Review Voucher program. FDA utilized this authority last year when adding two additional diseases, Chagas disease and neurocysticercosis, and as we learned from the Ebola crisis, it is critical to develop effective vaccines and treatments before an outbreak begins. This simple action by the FDA could spur development of an effective vaccine or treatment against Zika virus, and as a result save countless American lives.
We urge FDA to quickly exercise the authority provided by Congress to add Zika virus to the Neglected Tropical Disease list. Given the urgent nature of this matter, we would appreciate a response to this request no later than February 19, 2016.
We appreciate your attention to this important public health concern and look forward to your swift attention to this matter.
Sincerely,