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U.S. FDA moves to smooth path for complex generic drugs
October 2, 2017 / 2:52 PM / 2 months ago

U.S. FDA moves to smooth path for complex generic drugs

WASHINGTON, Oct 2 (Reuters) - The U.S. Food and Drug Administration on Monday announced a series of measures designed to speed to market complex generic drugs such as Mylan NV’s emergency EpiPen in an effort to address the rising cost of pharmaceuticals.

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.” (Reporting by Toni Clarke; Editing by Paul Simao)

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