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May 6, 2005

By JENNIFER CORBETT DOOREN
DOW JONES NEWSWIRES
May 6, 2005 1:59 p.m.

WASHINGTON -- The U.S. Food and Drug Administration on Friday issued guidelines for a new "Drug Watch" Web page aimed at giving consumers drug-safety information and released more details on its proposed drug-safety oversight board.

The board, which will consist mostly of FDA employees, would discuss emerging drug-safety issues and would be responsible for information posted on the Drug Watch Web page about drugs on the market.

The agency said it didn't expect to routinely make the deliberations of the board public, but that any relevant information would be distributed through the new Web page. The details of the proposed Drug Watch Web site will be published in Monday's Federal Register. The FDA is asking for a 90-day comment period, so any final action isn't expected until later this year.

The FDA said the Web site "is intended to identify drugs for which FDA is actively evaluating early safety signals." Drug companies would be notified shortly before a drug is placed on the Web page.

In February, the FDA said it would be launching a new series of drug-safety initiatives after the agency was questioned whether it moved fast enough to inform consumers of possible risks with Cox-2 painkillers and other drugs. In September, Merck & Co. removed its painkiller Vioxx from the market after a study showed it increased the risks of heart attacks and strokes. Last month the FDA ordered Pfizer Inc. to remove Bextra from the market, but allowed its other Cox-2 painkiller, Celebrex, to stay on the market with new warning information on the label.

The FDA noted generally that there is a "period of uncertainty" while the agency and a drug marketer evaluate new safety concerns. The Drug Watch page would "provide a forum in which we can communicate emerging safety information to the public while we continue to evaluate that information," the FDA said in its proposed drug watch guidance.

Late Thursday, the FDA posted new drug-safety information to its Web site on a page that contains drug-specific information aimed at both consumers and health-care professionals. Traditionally, the FDA has communicated drug-safety information to health-care professionals through its MedWatch program. That information can be found on the FDA's Web site.

The drug-specific information Web page contains information about proper drug usage for a variety of drugs, including any relevant safety information. The agency updated information Thursday for the acne drug Accutane and said it was monitoring reports of suicide among users of the medicine.

The FDA said before a drug would be placed on the Drug Watch page, a preliminary review of safety information would be considered by the Drug Safety Oversight Board. The agency said a drug or a class of drugs would be placed on drug watch only if the board determines if there is enough information to warrant further investigation about whether a safety problem may exist. Once safety issues are resolved a drug would be removed from the drug watch list.

The board would make recommendations about drug-safety issues to the head of the agency's Center for Drug Evaluation and Research, who would then make any final decisions on drug-safety issues. The board would likely meet once a month initially and then on an as-needed basis.

The head of the FDA's drug-evaluation division would make recommendations to the FDA commissioner about who should serve on the board. The commissioner would appoint board members.

The proposed board would have 15 voting members. Eight offices from within the Center for Drug Evaluation and Research would each have a member on the board. There would also be a member from center's device division and another from the biologics division. Another member would come from a non-FDA health agency, such as the National Institutes of Health, and another from a nonhealth government agency. The FDA said the board would also be able to call on outside consultants. Only three of the 15 board members would be from the office of new drugs, which decides whether to put new drugs on the market. The agency said people from that office wouldn't vote on a drug they approved if a safety issue arises.

Critics, such as Senate Finance Committee Chairman Charles Grassley (R., Iowa), have said the FDA needs a separate drug-safety office, and that having it housed under the same FDA umbrella that evaluates new drugs makes the agency reluctant to quickly address emerging drug-safety issues. He has proposed new legislation that would create a separate, free-standing drug-safety office. The FDA has said it believes its new drug-safety oversight board will help ensure the agency moves quickly to release relevant drug-safety information to consumers and health-care professionals.

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