New US agency needed for PMS, managed care pharmacy tells FDA

A separate US agency is needed to take care of post-marketingsurveillance of drugs and biologics, Judith Cahill, executive director of the Academy of Managed Care Pharmacy, has told the Food and Drug Administration's public meeting on the Prescription Drug User Fee Act (Marketletter November 26). Post-marketing surveillance is an essential programmatic function for the FDA if it is to fulfil its mission of promoting and protecting public health, she added.

The FDA had asked attendees whether PDUFA should allow use of user fee funding to monitor safety post-approval. Ms Cahill said that, while the improvement created by PDUFA and its 1997 extension, PDUFA II, "is most assuredly a boon for US citizens," it requires the pharmaceutical industry to perform greater surveillance once drugs are in non-clinical trial use.

Generally, FDA-approved medications are safe and effective only when used appropriately, but even when this is the case, there are potential side effects, and health care professionals and patients must judge whether the benefits outweigh the adverse secondary effects, she said. Also, problems are sometimes identified only after a drug has been on the market and available to a broader population than was tested during the approval process, or only after the passage of a certain period of review.