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Feb. 2 — The Zika virus would be added to the list of diseases that qualify for an FDA incentive program to develop products for rare and neglected diseases, under legislation introduced in the House.
Reps. G.K. Butterfield (D-N.C.) and Susan W. Brooks (R-Ind.) introduced H.R. 4400 Feb. 1, the same day the World Health Organization declared the mosquito-borne virus a public health emergency. The bill would add Zika to the list of diseases that qualify for the Food and Drug Administration's priority review voucher program, which allows the developer of a vaccine or treatment for a qualifying tropical disease to receive a voucher for FDA priority review for a second product of its choice. The voucher can be sold.
“This legislation is important because Zika virus is spreading rapidly and is thought to be linked to devastating birth defects in newborns,” Butterfield said in a Feb. 2 statement sent to Bloomberg BNA. “While Zika is primarily impacting populations abroad right now, it presents a serious threat to the United States and our population. We live in a global society and the research and development that happens in the U.S. will benefit individuals and families around the world. We urgently need a solution and the PRV program encourages the rapid development of safe and effective treatments and cures.”
Congress authorized the voucher program in 2007 as part of the Food and Drug Administration Amendments Act (Pub. L. No. 110-85). According to a draft guidance on tropical disease priority review vouchers, the program is designed to spur development of new drug and biological products to treat certain tropical diseases.
FDA spokeswoman Tara Goodin told Bloomberg BNA that the agency received the authority in 2014 to add to the list of qualified tropical diseases by issuing an order under the tropical disease priority review voucher program without going through Congress. But the authority required that the diseases meet the criteria “infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations.”
In August 2015, the agency published a final order in the Federal Register adding Chagas disease and neurocysticercosis to the list of “tropical diseases”.
But when asked if the agency was considering adding Zika to the list, she said, “We recognize the severity of this emerging virus, but the FDA cannot comment on diseases that may be under consideration” for the voucher program.
“The FDA is aware of the great interest by manufacturers in working to develop products to address Zika. We are committed to working in close collaboration with those product developers, as well as our U.S. government partners, international public health partners and regulatory counterparts to expedite the implementation of well-designed clinical trials during public health emergencies to test the most promising investigational products,” Goodin said in a Feb. 2 e-mail to Bloomberg BNA.
An updated list of diseases that qualify for the voucher program published last August in the Federal Register doesn't include Zika (80 Fed. Reg. 50,559). But dengue virus/dengue hemorrhagic fever, which falls into the same class of viruses as Zika and is spread by the same type of mosquito, does qualify. Goodin confirmed that this is the most recent list.
The bill has been referred to the House Committee on Energy and Commerce.
To contact the reporter on this story: Jeannie Baumann in Washington at email@example.com
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H.R. 4400 is available at http://1.usa.gov/1VHcx6s.
The World Health Organization statement is available at http://www.who.int/mediacentre/news/statements/2016/emergency-committee-zika-microcephaly/en/.
The Federal Register notice on the list of rare diseases that qualify is available at https://www.federalregister.gov/articles/2015/08/20/2015-20554/designating-additions-to-the-current-list-of-tropical-diseases-in-the-federal-food-drug-and-cosmetic.
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