FDA moves to smooth path for complex generic drugs

Dr. Scott Gottlieb testifies before a Senate Health Education Labor and Pension Committee confirmation hearing on his nomination to be commissioner of the Food and Drug Administration on Capitol Hill in Washington, D.C., U.S. April 5, 2017. REUTERS/Aaron P. Bernstein

WASHINGTON, D.C. — 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’s Advair asthma treatment.

GSK, the UK-based pharmaceutical company with 3,000 employees in the Research Triangle Park, won FDA approval in September for a new three-in-one inhaler called Trelegy Ellipta. It is the first once-daily triple medicine for chronic obstructive pulmonary disease (COPD).

GSK estimates that approximately a quarter of COPD patients already use the three drugs individually to treat COPD, and hopes its product will prove an attractive, easier alternative regimen. They say it will also cut co-pay costs for patients currently buying all three medicines separately.

An FDA advisory panel also voted last week 11-0 that the safety and efficacy of GlaxoSmithKline’s new Shingrix shingles vaccine warrants approval for its use in adults aged 50 and older.

Panel members said they were “very impressed” by efficacy data from Shingrix clinical trials, and that it represents an improvement over Zostavax, the only marketed shingles prevention vaccine from Merck & Co.