Regulatory woes may further slow FDA approvals, official says

SAN DIEGO — The current state of flux in Washington may temporarily slow down new drug approvals and disrupt operation of the U.S. Food and Drug Administration, a former FDA deputy commissioner said here.

The FDA approved a record low 14 new drugs and devices last year, the lowest number since 1983, and it may be 1 to 2 years after the presidential election before a new FDA commissioner is named and confirmed by Congress, Lester Crawford, PhD, senior counsel at Policy Directions, told attendees at the Ophthalmic Drug Development and Delivery Summit. The expected delay in naming a new commissioner could put the FDA into "hibernation" and further stress an agency suffering from a lack of funding, Dr. Crawford said.

Speculation on the cause of the low number of approvals is split: FDA statements have alluded to a lack of market-ready products in the pipeline, while some in big pharma and at FDA watchdog groups have cited a lack of resources at the agency, according to Dr. Crawford, who served in a variety of roles for the FDA from 1975 to 2005.

The outlook is particularly gloomy for ophthalmology, where there is a "significant lack of guidance at the FDA, especially as it relates to the development of ophthalmic drugs," Michael A. Swit, vice president of The Weinberg Group, said in a separate talk.