Drugmakers Support FDA’s Expanded Trial Eligibility Plan, GAO Says

September 16, 2019

Drug manufacturers are making progress toward the FDA’s goal of increasing access to investigational drugs outside clinical trials, the GAO says in a report released.

Of the 29 manufacturers interviewed, 23 companies posted their expanded access policies on their websites.  Only four stated they would not consider expanded access requests.

Reaction was mixed among drugmakers to the agency’s plan to broaden trial eligibility as seen in four FDA guidances released in March. Some feared that broadening eligibility could adversely affect a study’s ability to identify the effects of a drug. But two manufacturers said they followed the agency’s lead on trial eligibility because “it will facilitate the drug approval process.”

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