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 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.
White House spokeswoman Katie Hill said Obama was expected to sign
the bill, which she called a "small step" that could encourage the
private sector to tackle Zika.
"But it contains no funding and is ultimately insufficient on its
own, since it doesn't provide the $1.9 billion in funding that our
public health experts have said is needed right now to prepare
Americans for the imminent local transmission of Zika in this
country," she said in a statement.
 Democrats and administration officials are urging the
Republican-controlled Congress to grant nearly $1.9 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.
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, include Sanofi SA, GlaxoSmithKline Plc, Inovio
Pharmaceuticals Inc and Takeda Pharmaceutical Co Ltd.
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.
On 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.
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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.
Developing a new drug can take years and cost millions of dollars. A
standard FDA review takes at least 10 months to complete - longer if
the agency requires additional information. Being able to shave time
off that process and get a profitable drug onto the market faster
can be worth millions of dollars to a manufacturer.
Under the agency's priority review program, companies who submit a
drug for review that is 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 least 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 receive 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 is developing a drug for one of more than 20 tropical
diseases listed under the voucher program. These include 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; Additional
reporting by Timothy Gardner; Editing by Bernard Orr)
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