FDA Approved Over 99 Percent of Expanded Access Requests in 2016

The FDA granted over 99 percent of requests for expanded access in fiscal 2016, including 100 percent of emergency IND applications and protocols.

In total, CDER and CBER received 1,757 expanded access INDs and protocol requests and approved 1,741, granting severely ill patients access to drugs and biologics currently under development. The FDA has consistently approved nearly all expanded access requests over the past several fiscal years.

Those statistics have been the agency’s main rebuttal to state and federal attempts to pass “right-to-try” legislation – bills that would allow terminally ill patients access to drugs that have passed Phase I safety testing. More than 30 states have passed versions of the bill.

A federal version of the bill introduced last month would bar the FDA from considering adverse event reports, deaths, or other outcome data from patients granted access to unapproved therapies. President Trump has also expressed concern over terminally ill patients not being able to access medicines.