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# FDA Expanded Access Pilot Coming
- URL: https://www.fdaweb.com/fda-expanded-access-pilot-coming/
- Published: 2019-01-30T12:00:00.000Z
- Updated: 2026-09-15T00:58:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143259

FDA commissioner **Scott Gottlieb** says the agency is developing a pilot program to help patients navigate the expanded access protocol to receive access to drugs that have not yet been approved. Speaking on a wide-ranging American Society of Clinical Oncology [podcast](http://action.ascou.libsynpro.com/exclusive-interview-fda-commissioner-talks-drug-pricing-expanded-access-and-tobacco-in-new-asco-in-action-podcast?et%5Fcid=40744634&et%5Frid=931308221&linkid=Lead+1%5Fbutton&ref=fdaweb.com), Gottlieb said the pilot will enable agency personnel to speak on the telephone with drug sponsor staff to better understand why a company may not want to provide its product to an expanded access patient.

Gottlieb also said FDA is working to take advantage of the many new opportunities arising through technology, such as gene therapy. He noted that the agency developed its software pre-certification model because there was a need for a regulatory framework that could keep up with rapid changes in product innovation and not require submission of an application every time a company wanted to implement a product modification.

Under the pre-certification model, he said, FDA regulates the company, rather than its individual products, providing a very different approach to innovation.

Asked about the new FDA Office of Drug Development and Science, Gottlieb said it will create infrastructure to better validate scientific tools being used to help advance drug development. He likened the work to the use of modeling and simulation 15 years ago when he was a deputy commissioner.

On drug prices, Gottlieb said FDA’s role is to promote competition. He said the agency is also looking for a regulatory pathway to facilitate follow-on innovation, because second-to-market innovation is taking much longer to come to market.