FDA Launches Call Center for Compassionate-Use Requests

The FDA has launched a call center to field doctors’ requests for access to experimental cancer drugs for individual patients who have run out of treatment options.

The pilot program, called “Project Facilitate,” was revealed at the 2019 American Society of Clinical Oncology annual meeting, where agency officials passed out cards providing a phone number and email address for doctors to use with compassionate-use requests for drugs that the agency hasn’t approved for marketing.

Compassionate-use requests for experimental treatment may arise when patients can’t participate in clinical trials, for reasons that range from not meeting eligibility criteria to living too far from a study site, and when FDA-approved treatment options are not available. In these instances, the pharmaceutical company decides whether to provide access to the drug, then the FDA reviews the request.

The cumbersome nature of the compassionate-use requests compelled 41 states to pass “Right to Try” laws in the past several years, which allow patients to bypass the FDA’s expanded-access program. Last year, President Donald Trump signed a federal law to similar effect.

Project Facilitate provides a single point of contact, simplifying a process that many doctors, especially those in community oncology clinics, consider “difficult to maneuver,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, told The Wall Street Journal.

The agency is urging doctors to call the new center before seeking compassionate-use permission from drug manufacturers so that it can work directly with the company if the request is denied. For approvals, the FDA plans to follow up with doctors regarding treatment results, which will then be studied for potential additional drug uses.

Dr. Pazdur said that the program is being tested for cancer drugs first, then may be expanded to drugs for other diseases.

Source: The Wall Street Journal, June 3, 2019.

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