FDA moves to smooth path for complex generics
U.S. FDA moves to smooth path for complex generic drugs
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 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.”
Complex drugs include medicines like metered-dose inhalers to treat asthma that have at least one feature difficult to copy under existing rules, 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.
Mylan, which faced an uproar over the escalating price of the EpiPen last year, culminating in a congressional hearing on the matter, has itself complained about getting its own versions of complex drugs onto the market, including its copy of GlaxoSmithKline Plc’s Advair asthma treatment.
Reporting by Toni Clarke; Editing by Paul Simao