Right to Try Legislation Fails; Why Keeping the FDA Central to the Expanded Access Process Is the Right Move

Article ID: 691066

Released: 13-Mar-2018 9:05 PM EDT

Source Newsroom: Clinical Research Pathways

Expert Pitch

Newswise — Marorie A. Speers, Ph.D. and executive director of the WCG Foundation, is available to comment on right to try legislation that failed in the U.S. House today

Her statement:

"It is important to understand that access to investigational drugs for desperately ill patients when there are no other standard treatment options or clinical trials already exists: FDA's expanded access program. Following review by product manufacturers, FDA carefully considers such requests. And in more than 99 percent of these cases, FDA grants its approval for use of the drug. Then Institutional Review Boards (IRBs) review the requests to ensure patient safety and informed consent.

"All three groups involved work hard on behalf of patients' interests, ensuring that their safety and welfare remains paramount in the process. If any laws in this area are changed or new ones are introduced, I believe it's important that FDA retains its critical role in the process."


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