Report criticizes FDA drug oversight

The Baltimore Sun

WASHINGTON -- The Food and Drug Administration's ability to assure the safety of prescription drugs is seriously compromised by internal squabbling, insufficient resources and inadequate authority, according to a long-awaited report released yesterday.

The report, by the Institute of Medicine, a part of the National Academy of Sciences, adds to criticism of an agency embattled since revelations of deaths from certain painkillers and implantable heart devices began appearing in 2004. Its recommendations may also bolster reform efforts in Congress.

At times scathing, the 350 pages describe a drug department at the FDA whose inter-office disputes, underfunding and frequently weak powers limit its oversight of drug safety, especially newly approved prescription medicine. The report said the agency needs to pay more attention to drugs once they go on sale and needs additional authority to do so.

"We found an imbalance in the regulatory attention and resources available before and after approval," said Sheila P. Burke, who chaired the committee writing the report. "Many of the report's recommendations are intended to bring the strengths of the pre-approval process to the post-approval process."

Once a drug goes on sale, the FDA has little power to withdraw it from the market or restrict its use other than negotiating with the drug's maker or making a public pronouncement -- even when there are reports of serious side effects. But serious problems with a drug often don't surface until the first few years of widespread sales.

So the report recommends labeling new drugs with a symbol and giving the FDA authority to restrict their advertising and sale during the initial years. The agency should also be able to fine companies or withdraw their pharmaceuticals if the companies don't finish studies monitoring the safety of a drug after its approval, the report recommends. Drugs based on new molecular compounds, versus improved versions of existing drugs, should be reviewed by the FDA after five years of sales, it said.

The FDA requested the report in early 2005 amid scrutiny over its handling of Vioxx and other products. Dr. Andrew C. von Eschenbach, the acting FDA commissioner, said the agency has been making improvements, which include making drug inserts more reader-friendly, establishing a drug safety board and updating the system for collecting reports of serious side effects.

Von Eschenbach welcomed the report. "I'm committed to taking additional steps and will look to the initiatives recommended by the Institute of Medicine to ensure we continue to fulfill our mission," he said.

The confirmation of von Eschenbach, which is being held up by two Republican senators reportedly unhappy with the FDA's stance on imported drugs and the abortion pill RU-486, may receive a boost from the report. It emphasizes the importance of a strong, independent and permanent FDA commissioner and recommends that commissioners serve six-year terms.

The Institute of Medicine, which counsels the federal government on health issues, held a number of hearings to solicit input. Many of its findings and recommendations reflect the conventional wisdom on improving federal drug regulation.

Some of the recommendations have been proposed in legislation crafted by Sen. Michael B. Enzi, a Wyoming Republican who chairs the health committee, and Sen. Edward M. Kennedy of Massachusetts, the committee's senior Democrat.

The recommendations also track other legislative proposals. The time is ripe for making changes to the FDA because a key law governing its funding, staffing and process for approving drugs is up for renewal next year. Sen. Charles E. Grassley, an Iowa Republican and a leading agency critic, called on the Bush administration and Congress to heed the report's call for change.

"Vioxx was like a dead canary in a coal mine, a warning that worse may yet come. Today there's no question left that we need to strengthen post-market surveillance in order to improve drug safety and save lives," Grassley said in a statement.

Since companies withdrew Vioxx and certain implanted heart defibrillators and other products from the market, the pharmaceutical industry has taken steps addressing criticism, such as limiting direct-to-consumer advertising of newly approved drugs. The industry trade group, Pharmaceutical Research and Manufacturers of America, cautioned against overreaction.

"It is essential to make sure that efforts to improve the drug safety system do not hurt patient access to medicines needed to treat a range of debilitating diseases and medical conditions. It is also important to remember that all drugs have risks and the FDA has an effective system that weighs benefits and risks throughout the lifecycles of medicines," Senior Vice President Caroline Loew said in a statement.

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