Washington — Scorched by controversy over how it approves prescription drugs for the marketplace, the U.S. Food and Drug Administration (FDA) is preparing to establish an independent Drug Safety Oversight Board (DSB) to monitor FDA-approved pharmaceuticals and update physicians and patients when new information becomes available.
Creation of the new board was announced in February by new House and Human Services Secretary Mike Leavitt shortly after his confirmation by the Senate. The agency has been criticized in recent months for acting too slowly following reports linking the arthritis drug Vioxx and pain drug Celebrex to increased risks of heart attack and stroke.
Dose of caution Only a few days before that announcement, a dose of caution was exercised by an FDA advisory panel, which recommended that the eczema-treating drugs Elidel (Novartis) and Protopic (Fujisawa) should carry a "black box" warning about a potential risk of cancer and infection (see News Briefs, p.19).
During the hearing, Dianne Murphy, director of the Office of Pediatric Therapeutics at FDA, said FDA officials are concerned because of animal models that indicate the products could contribute to an increase in cancer.
"We have no human proof, but the monkey data was very concerning," she says.
In a statement issued following the hearing, Novartis AG, the manufacturer of Elidel, said the "black box" warning was "unwarranted and not substantiated by clinical evidence."
Black boxes are considered the strongest possible labeling on prescription drug products. The FDA generally, but not always, follows the advice of its advisory panels. Novartis AG said about 5 million people use Elidel worldwide.
Just two weeks after the advisory council recommendation, Novartis AG announced that data from a long-term study of adult and pediatric patients with atopic dermatitis showed that Elidel cream provided sustained control of symptoms associated with eczema.
"This study provides encouraging news because one of the most unsettling aspects of eczema is the unpredictability of the condition," says Richard Langley, assistant professor, director of research, division of dermatology, Dalhousie University, Canada. "What this study shows is that using Elidel to treat a flare-up at the onset of such symptoms as tingling or itching may enable patients to control flares and better manage their condition long term."
The objective of the multinational study was to evaluate the long-term safety and effectiveness of the drug in pediatric and adult patients with eczema of any severity who had previously completed a six-month, 947-patient core study. The extension study included 368 of those patients who were treated up to 18 months.
More pressure Clearly, with its new DSB, the FDA will be applying even more pressure to drug companies to be cautious with their products. Creation of the DSB signifies a new era of caution within the agency itself.
"The challenge for the twenty-first century at FDA is that traditional scientific methods for evaluating health products both before and after a product is approved move methodically and deliberately, and generalities about medical care often are hollow when applied to individual patients with individual needs," says FDA Commissioner Lester M. Crawford, D.V.M.
Dr. Crawford says the new DSB will "enhance the independence of internal deliberations and decisions regarding risk and benefit analyses and evaluations and consumer safety." He said the DSB will oversee management of important drug safety issues within the Center for Drug Evaluation and Research.
The DSB will comprise members from the FDA and medical experts from other Health and Human Services agencies and government departments, such as the Department of Veterans Affairs. The board will consult with other medical experts and representatives of patient and consumer groups, he says.
In addition, Dr. Crawford says FDA will improve communication to consumers.