FDA responds to drug safety blueprint

The agency unveiled a plan to enhance its oversight, but congressional action is needed to carry out the broader revamp called for by the Institute of Medicine.

By Susan J. Landers — Posted Feb. 26, 2007

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The Food and Drug Administration's Jan. 30 announcement of planned changes in the way it oversees drug safety was met with yeas, nays and some cautious "time will tell" observations.

The agency announcement came in response to recommendations made last fall in an Institute of Medicine report detailing the FDA's difficulties.

As a result, the agency said it would place increased emphasis on the science of drug safety to identify risky drugs before they reach consumers and to take steps to improve postmarketing surveillance of at least some new products to spot emerging dangers.

The FDA has come under fire in recent years as unsettling information surfaced about delayed warnings of serious side effects from marketed drugs such as COX-2 inhibitors and selective serotonin reuptake inhibitors. Charges were made that public health was taking a back seat in a drug approval system that seemed to cater more strongly to the needs of pharmaceutical companies than to safety.

The fact that changes were needed had been recognized by nearly everyone except, until now, the agency itself, said observers who welcomed the change in attitude.

The FDA's response seemed "conciliatory," said Bruce Psaty, MD, PhD, MPH, professor of medicine and epidemiology at the University of Washington in Seattle and a member of the IOM committee that drafted the 2006 recommendations.

The agency's standard reaction to past criticisms had been that there are no problems, Dr. Psaty said. "The tone here is very different." Still, he cautioned, "I have to see how it plays out. Whether the effect is to improve drug safety remains to be seen."

Some of the FDA responses fell short of the recommendations, Dr. Psaty said. The agency intends to hire outside consultants to help improve the culture of the FDA, which has seen staff morale drop and credibility decline. But the IOM had recommended that the secretary of the Dept. of Health and Human Services appoint an external advisory board.

Curt Furberg, MD, PhD, professor of public health sciences at Wake Forest University School of Medicine in Winston-Salem, N.C., saw both positives and negatives in the agency proposals. "The good thing is they recognized that they have a problem."

But the plan represents only a partial fix. "They took the easy recommendations as I saw it and offered sometimes vague solutions," Dr. Furberg said. "For example, they said they will do some pilot tests to monitor safety. Well, they set no deadlines, and the pilot tests are too short." He is on the FDA's Drug Safety and Risk Management Advisory Committee.

Improvements welcomed

The AMA commended the agency's action. "The FDA proposal would strengthen the science that supports the nation's drug safety system and improve FDA operations and management," said AMA Board of Trustees Chair-elect Edward L. Langston, MD.

The Association also welcomed the agency's intention to improve the way drug risks are communicated to patients and expressed interest in working with the FDA to devise better ways to convey information about such risks to physicians, Dr. Langston said.

Pharmaceutical industry representatives looked beyond the FDA response to the larger drug approval scene. "When it comes to patient safety, there is always room for improvement," said Alan Goldhammer, PhD, deputy vice president of the Pharmaceutical Research and Manufacturers of America, an advocacy organization for large drug companies. "But the FDA, in its IOM response, makes clear that important efforts to improve drug development and safety have been under way for years, and more promising initiatives have been proposed as part of the reauthorization of the Prescription Drug User Fee Act." Reauthorization of that law, PDUFA, is scheduled for the spring.

The FDA responded to the IOM's 25 recommendations either with agency plans for action or by pointing to other routes, such as congressional action to reauthorize PDUFA, as ways to realize goals. PDUFA, first passed in 1992, adds fees paid by the pharmaceutical industry to the FDA budget.

It is also widely recognized that the agency is underfunded and could use a monetary boost from Congress.

Several other changes could result from a drug safety bill sponsored by Sens. Edward Kennedy (D, Mass.) and Mike Enzi (R, Wyo.) that has been reintroduced in the new Congress.

"The initiatives we are announcing today are not the whole story, nor are we in the final chapter of that story," said FDA Commissioner Andrew von Eschenbach, MD, when he unveiled the agency plans.

Meanwhile, the FDA intends to proceed with actions over which it exercises control, such as improving the use of its advisory committees and increasing their epidemiologic expertise by using either outside or agency personnel during relevant discussions. The agency also aims to reconsider its criteria for granting waivers that allow advisory committee members to serve despite having financial ties to a product under review.

A newsletter is also in the works for the FDA Web site. It will contain summaries of results and methods used in postmarketing drug reviews, but not confidential drug company information. In addition, the newsletter will report on emerging safety concerns to provide physicians with early alerts as to problems with marketed drugs.

Dr. Psaty remained skeptical of the benefit of a newsletter. "I'm a general internist, and if this letter is filled with cancer drugs and drugs I'm not using, I may not pay much attention to it. I'll have to see how some of these things work.

"They aren't bad ideas. It depends on how they are implemented."

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Improving drug safety

A new plan by the Food and Drug Administration to strengthen its drug safety system has three key components:

  • Strengthening the science that supports the agency's medical product safety system at every stage of the product approval process, from premarket testing through post-market surveillance. This includes developing new scientific approaches for detecting, understanding, predicting and preventing adverse events and conducting a pilot program to review on a regular basis the safety profiles of certain newly approved drugs.
  • Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products by establishing an advisory committee to provide input on how to improve the agency's risk communication policies and practices and develop a comprehensive risk communications strategic plan.
  • Improving operations and management to ensure implementation of review, analysis, consultation and communication processes needed to strengthen the drug safety system. This would be done by hiring external management consultants to help the Center for Drug Evaluation and Research develop a comprehensive strategy for improving its organizational culture and making specific organizational and management changes to increase communications among review and safety staff.

Source: "The Future of Drug Safety -- Promoting and Protecting the Health of the Public," Food and Drug Administration, January

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External links

"The Future of Drug Safety -- Promoting and Protecting the Health of the Public," Food and Drug Administration, January (link)

"The Future of Drug Safety: Promoting and Protecting the Health of the Public," Institute of Medicine, Sept. 22, 2006 (link)

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