FDA granted 99% of applications for access to unapproved drugs in FY 2016

The Food and Drug Administration approved more than 99 percent of expanded access requests in 2016, reports Regulatory Focus.

Here are six things to know.

1. The FDA's expanded access program allows patients with serious of life-threatening illnesses to use drugs not yet approved by the agency. Physicians file paperwork with the FDA to request access to an experimental drug for a specific patient or group of patients, according to the report.

2. The agency's Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research received 1,757 total expanded access requests during fiscal year 2016.

3. CDER received 1,554 of those requests and approved 99.4 percent. CBER received the remaining 203 requests and granted 96.6 percent.

4. The FDA consistently approves a majority of the requests it receives, according to the report. In fiscal year 2015, the agency approved 99 percent of expanded access requests.

5. More than 30 states enacted right-to-try laws, which allow patients to get unapproved treatments directly from drugmakers, bypassing any involvement from the FDA, according to Regulatory Focus.

6. "Based on information available, it appears that pharmaceutical companies turn down considerably more applications from physicians than does the agency," Peter Lurie, FDA's associate commissioner for public health strategy and analysis said while testifying before a Senate committee in September. "For example, one company indicated that it had turned down 98 of 160 applications for a single drug in a six-month period."

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