FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Discusses Pilot Program for Single Patient INDs

May 24, 2019
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The FDA said it plans to reach out to drug manufacturers that turn down oncologists’ requests for single patient investigational new drugs (INDs) through a pilot program designed to restructure applications for expanded access.

Speaking at a public workshop on Project Facilitate, Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said the program is looking to identify pharmaceutical companies who decline or have policies denying certain INDs and why they choose to do so.

“We are attempting to facilitate the [single patient IND] process,” said Pazdur. “We are attempting to find out the number of patients that are requesting these single patient INDs, and interacting with pharmaceutical companies to understand if they are not giving these drugs out, why” not.

A public database tied in with the program will also list relevant information supplied by drug companies, including each company’s policies on expanded access and its expanded access contact information.

FDA Acting Commissioner Ned Sharpless, who also attended the workshop, called the pilot an “important endeavor to try and facilitate access for patients” who are very sick and have little to no options left.

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