Congress sends Obama bill incentivizing Zika drug development

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Source:   —  April 13, 2016, at 2:37 AM

S. lawmakers on Tuesday approved a bill to allow financial incentives to companies developing treatments for the Zika virus, sending the measure on to the White House for President Barack Obama'south signature.

n">U. S. lawmakers on Tuesday approved a bill to allow financial incentives to companies developing treatments for the Zika virus, sending the measure on to the White House for President Barack Obama'south signature.

The measure allows the Food and Drug Administration to comprise Zika drug developers in the agency'south priority review voucher program. The program encourages manufacturers to study treatments for diseases that mightn't be profitable by expediting the regulatory review of a more profitable 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 executive 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 latest week that it'd redirect $589 million in allocated funds to prepare for the mosquito that carries the sickness to emerge in the continental United States.

According to the World Health Organization, there is a powerful scientific consensus that the Zika virus can cause the scarce birth defect microcephaly in newborns. But the link between the virus and the birth defects hasn't been scientifically established.

On 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, comprise Sanofi SA, GlaxoSmithKline Plc, Inovio Pharmaceuticals Incorporated and Takeda Pharmaceutical Co Ltd.

Zika was first detected in Brazil latest 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 scarce neurological disorder, in adults.

On Monday, top health executive said the mosquito that spreads the virus is presently present in about thirty U. S. states, making local outbreaks a possibility. They've also predicted hundreds of thousands of people would be infected in PR 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 expand 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.

Developing a new drug can get years and cost millions of dollars. A standard FDA review takes at least ten months to complete - longer if the agency requires extra information. Being able to shave time off that process and obtain a profitable drug onto the market faster can be worth millions of dollars to a manufacturer.

Below the agency'south priority review program, companies who submit a drug for review that's intended to treat serious conditions or whose drug shows a significant improvement in safety or effectiveness over existing treatments is eligible to be reviewed in six months, at minimum four months faster than usual.

A priority review voucher gives a company the right to a six-month review on any product, regardless of whether it meets the conditions normally required to get an accelerated review. It also gives the company the right to sell the voucher to another company.

The law currently makes any company eligible for a priority review voucher that's developing a drug for one of more than twenty tropical diseases listed below the voucher program. These comprise malaria, cholera, leprosy, dengue, tuberculosis, and ebola. The FDA has the authority to add other infectious diseases to the list which primarily affects poor countries.

(Reporting by Toni Clarke and David Morgan in Washington; Editing by Bernard Orr)

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