4:13 PM
Nov 08, 2018
 |  BC Extra  |  Politics & Policy

Gottlieb highlights changes to improve expanded access program

FDA Commissioner Scott Gottlieb on Thursday highlighted recent and upcoming changes to the agency's expanded access program (EAP) that the agency believes will improve access for patients and remove ambiguity for companies.

Gottlieb said the agency has worked over the past year to expand and update the program by streamlining the paperwork and simplifying internal review board (IRB) review. If a single patient requests expanded access, now only one IRB member is needed to approve the request, rather than the entire board.

In October, FDA updated its guidance on EAPs, in which the agency emphasized that no adverse event data from a program that FDA has reviewed, has prevented the agency from approving a drug.

FDA plans to update its EAP webpages to improve usability by streamlining content and making it more user-friendly in the wake of an independent report, which found confusion with program navigation, as well as difficulties with multistakeholder coordination and an administrative burden, to be the program's largest issues.

In addition, Gottlieb said FDA plans to establish an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program, under the oversight of the Office of Clinical Policy and Programs, as part of its proposed reorganization of the Office of the Commissioner (see "FDA Reorganizing Commissioner's Office").

Gottlieb also said that FDA is working to implement right-to-try legislation that President Donald Trump signed into law in May. On Thursday, the agency launched a webpage to help patients understand the alternative patient access pathway.

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