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[e-lek] FDA aims to speed up arrival of complex generic drugs

E-DRUG: FDA aims to speed up arrival of complex generic drugs
[This move could lead to wider and more affordable availability of a
generic version of
'EpiPen'  BS]

Reuter Health News
October 2, 2017

FDA aims to speed up arrival of complex generic drugs
Reuters Staff
WASHINGTON (Reuters) -

The U.S. Food and Drug Administration on Monday announced a series of
measures designed to speed to market generic versions of complex drugs such
as Mylan NV's emergency EpiPen in an effort to address the rising cost of

The measures, announced in a blog post by Commissioner Scott Gottlieb,
stray into an area that has not previously been the FDA's purview: drug
prices. The agency has typically made its decisions based on safety and
efficacy without regard to cost.

Gottlieb said the measures are designed to increase competition in the
market by enabling generic competition to complex drugs, something he has
long argued for.

"Drug access is a matter of public health concern," Gottlieb said. "We know
that enabling more generic competition, where Congress intended, helps
reduce prices, enable more access, and improve public health."

Complex drugs include medicines like metered-dose inhalers to treat asthma
that have at least one feature difficult to copy under existing rules, such
as complex active ingredients or formulations, which means those drugs can
face less competition.

"In some cases, costly, branded drugs that are complex drugs have lost
their exclusivity but are subject to no generic competition," Gottlieb said.

President Donald Trump has raised the issue of high drug prices, especially
early in his presidency, but to date little action has been taken.

Mylan, which faced an uproar over the escalating price of the EpiPen last
year, culminating in a congressional hearing, has itself complained about
delays getting its own versions of complex drugs onto the market, including
its copy of GlaxoSmithKline Plc's Advair asthma treatment. Mylan's shares
rose 2.8 percent in afternoon trading while U.S.-traded shares of generic
drug maker Teva Pharmaceutical Industries Ltd rose 4.4 percent in New York.

Gottlieb's stance on complex generics extends a broader shift by the FDA
away from a simple consideration of safety and effectiveness. Under
pressure from members of Congress it is now also taking into account
broader social implications, especially in relation to its opioid drug
approvals. Gottlieb sees increasing competition in the pharmaceuticals
market as a matter of public health. "If consumers are priced out of the
drugs they need, that's a public health concern that FDA should address,"
he said.

Posted by
Lucas F.M. van der Hoeven
The Netherlands / Europe
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