FDA video features accelerated drug approval program

August 16, 2012

FDA’s latest “Drug Info Rounds†video for health professionals helps pharmacists understand the agency’s Accelerated Approval Program for drugs when there is an unmet medical need.

FDA’s latest “Drug Info Rounds” video for health professionals helps pharmacists understand the agency’s Accelerated Approval Program for drugs.

In the video, an FDA pharmacist, Commander Catherine Chew, explains how the agency approves drugs in the program when there is an unmet medical need. “An unmet medical need simply means providing a therapy when none exists, or providing a new therapy that may be superior to or less toxic than an existing one,” Chew said.

Without the clinical outcomes present that the FDA would normally use to approve a drug, the program allows for the use of a surrogate end point in clinical trials. “These are markers or a physical sign of sorts, used as an indirect measurement to predict a clinically meaningful outcome like survival or symptom improvement,” Chew said.

For example, instead of waiting to learn whether a drug prolonged survival in cancer patients, FDA has approved drugs based on evidence that they shrink tumors. “As a surrogate end point, tumor shrinkage is reasonably linked to a real clinical benefit,” Chew said.

FDA’s Drug Info Rounds videos feature several topics for pharmacists, including “Drug Shortages” and “Communicating Drug Safety Messages.”