Sweeping Changes Sought at FDA

Sept. 22, 2006 — -- Sweeping changes would be made in the way drug companies operate and in the power of the Food and Drug Administration to oversee them if Congress and the FDA adopt new recommendations from the Institute of Medicine, a nonprofit organization created by Congress to advise the federal government on health issues.

If the recommendations in the 200-plus-page report are adopted:

In addition to those recommendations, the IOM report said the FDA suffers from a lack of regulatory authority, organizational problems and a chronic lack of funds and staff. The report calls for increased funding and staffing at the FDA, and more public access to drug studies and safety data. The FDA should be given more authority to fine drug companies, as well as to file injunctions against them and regulate how they do business. It should also be given the power to order withdrawals of drugs. No more "all-or-nothing approach," according to the report.

"We want to provide a tool kit of regulatory options," said Sheila Burke, chairwoman of the IOM Committee on the Assessment of the U.S. Drug Safety System.

The report recommends that the FDA tightly regulate drug advertising on new medications and continue to review new safety data on drugs even after they are approved.

"We want to establish restrictions on direct-to-consumer advertising until safety can be established," said Alto Charo, a member of the IOM committee.

Other experts agree that pushing new drugs on consumers before safety can be firmly established is a bad idea.

"Since the medication is not yet known to be safe, direct-to-consumer advertising should be forbidden," said Alan Sager, professor of health services at the Boston University School of Public Health. "This should be legislated and then defended in court."

Although the report criticizes the agency, the FDA actually asked for the critique. The FDA itself commissioned the report from the IOM in light of the concerns that were raised when Merck withdrew the painkiller Vioxx in 2004.