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Panel: FDA Needs Drug-Safety Reforms

Sept. 22, 2006 -- The Institute of Medicine (IOM) on Friday sharply criticized the FDA for a dysfunctional professional culture, while also urging Congress to grant it new power to police the safety of prescription drugs on the U.S. market.

The report is not the first to detail problems at the agency, which has suffered from low public opinion because of a series of missteps, including the recall of the pain drug Vioxx. But it is the most sweeping report to date, recommending broad reforms of how the agency deals with employees, the drug industry, and consumers.

A panel of IOM experts urged Congress to give the FDA several powers it now lacks, including the ability to order drug companies to alter labels to reflect safety concerns, and the authority to fine firms that refuse to perform new safety studies of drugs being sold. Now, labeling changes and safety studies are a matter of negotiation between regulators and the drug industry.

The FDA should have the new authority, "and to enforce that through fines or injunctions if necessary," says R. Alta Charo, JD, a professor of law and bioethics at the University of Wisconsin School of Medicine, and a member of the IOM's panel.

New Label Symbols

Experts also recommended a new labeling system that would designate newly approved drugs with a special symbol on the packaging. Direct-to-consumer advertising should be restricted or banned entirely during the time the drug bears the symbol, the report urged.

Some experts faulted widespread direct-to-consumer advertising for spreading Vioxx and other Cox-2 inhibitor drugs to millions of patients who may have been put at unnecessary risk for heart attacks and strokes.

"Approval does not in fact signify the end of uncertainty about a drug," says Sheila Burke, MPA, RN, the chair of the committee.

Several drug makers, under pressure from members of Congress, volunteered last year to limit consumer ads during the first six months to one year of a drug's marketing life. Charo says the committee envisioned a two-year restriction, but that FDA should be able to adjust the time as it sees fit.

FDA Leadership

The report pegs a lack of consistent leadership at the top of the agency as a key ingredient to growing interdepartmental squabbles and infighting. The agency has lacked a permanent commissioner for more than half of the last eight years, as the politicization of the position has grown.

Experts say the commissioner should be appointed for a six-year term. That makes it more likely that appointees would span administrations and be more immune to politics.

"We were all concerned about the frequent turnover in that position," Burke told reporters. What you want is essentially someone who is looking longer term."