U.S. Lawmakers Approve Bill to Provide Financial Incentives to Companies Developing Treatments for the Zika Virus

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U.S. lawmakers last week approved a bill to provide financial incentives to companies developing treatments for the Zika virus, sending the measure on to the White House for President Barack Obama’s signature.

The measure allows the Food and Drug Administration to include Zika drug developers in the agency’s priority review voucher program. The program encourages manufacturers to study treatments for diseases that might not be profitable by expediting the regulatory review of a more lucrative drug in their research pipeline.

The House of Representatives passed the bill on a voice vote, without a roll call, weeks after the same measure was approved by the Senate. Democrats and administration officials are also urging the Republican-controlled Congress to grant $1.8 billion in emergency funds to combat the spread of Zika.

In a temporary fix, the White House said last week that it would redirect $589 million in allocated funds to prepare for the mosquito that carries the disease to emerge in the continental United States.

According to the World Health Organization, there is a strong scientific consensus that the Zika virus can cause the rare birth defect microcephaly in newborns. But the link between the virus and the birth defects has not been scientifically established.

Last Tuesday, Brazil confirmed 1,113 cases of microcephaly and considers most to be related to Zika infections in the mother. Drugmakers who are working on Zika-related drugs, or considering such research, include Sanofi SA (Paris), GlaxoSmithKline PLC (London), Inovio Pharmaceuticals Inc. (San Diego CA) and Takeda Pharmaceutical Co Ltd. (Osaka JPN).

Zika was first detected in Brazil last year and is spreading through the Americas. The World Health Organization had declared a global health emergency due to the virus’s possible link to microcephaly in babies and Guillain-Barre syndrome, a rare neurological disorder, in adults.

Last Monday, top health officials said the mosquito that spreads the virus is now present in about 30 U.S. states, making local outbreaks a possibility. They have also predicted hundreds of thousands of people would be infected in Puerto Rico when the mosquito season kicks in this summer. It could also emerge on the U.S. mainland.

A pharmaceutical company may be given a priority review voucher to develop a drug for an infectious disease, in this case Zika, which may not generate much profit for the manufacturer. The voucher gives the company the right to an accelerated review by the FDA of any other, more lucrative, drug in its pipeline.

Monday, April 18, 2016 / Vol. 24 / No. 15


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