FDA advances Drug Watch safety initiative

Washington -- An early warning system proposed by the Food and Drug Administration to alert physicians and patients to emerging risks posed by drugs already on the market is beginning to take shape, with draft recommendations published and an oversight board named.

The activities are part of the FDA's attempts to alleviate concerns raised about the agency's ability to ensure the safety of the nation's prescription drugs. The agency recently came under attack for what many charged were unnecessary delays in disclosing cardiovascular risks posed by COX-2 inhibitors and a heightened risk of suicide among adolescents who took selective serotonin reuptake inhibitors.

To prevent similar information delays in the future, the FDA intends to post to a new "Drug Watch" Web site data that suggest a drug poses a risk not seen during clinical trials.

"The purpose of the Drug Watch Web page is to provide a forum in which we can communicate emerging safety information to the public while we continue to evaluate that information," noted the FDA's draft guidance on the new system. The draft is available on the agency's Web site for comment until August 4.

The ultimate goal of the new initiative is to provide some "transparency" to agency decisions, said a spokeswoman. For example, one such web posting might read: "FDA is investigating postmarketing reports of renal failure in elderly patients treated with Drug A, but a causal relationship has not been established. We are continuing to analyze these reports to determine whether the occurrence of these adverse events affects the risk/benefit assessment of Drug A therapy."

Posted information may also warn physicians of possible risks affecting only some patients, thus allowing them to avoid prescribing a drug to those at heightened risk.

Often physicians and their patients are not aware of these emerging risks until the FDA issues an official warning or the manufacturer withdraws the drug from the market.

Although the FDA compiles a great deal of safety information, much of it is currently available only in response to requests made under the Freedom of Information Act.

Conflict free

Exactly what will be posted on the Web site is to be determined by the members of a Drug Safety Oversight Board whose names were released on May 18. All are federal employees, most from the FDA with a few from the Veterans Administration and National Institutes of Health.

Chairing the group is Douglas Throckmorton, MD, who is also acting deputy director for the FDA's Center for Drug Evaluation and Research. Susan K. Cummins, MD, MPH, who previously chaired the Dept. of Health and Human Services' Advisory Committee on Childhood Lead Poisoning, will be the board's executive director.

Although other members will remain in their regular agency positions, executive director will be Dr. Cummins' sole FDA position.

The oversight board may also consult with the chairs of the FDA advisory committees and other sources from outside the agency, according to an FDA announcement.

However, to guard against conflict of interest, all board members are to be independent of the agency's drug review process. Board members are to be recused from voting on an issue concerning a specific drug if they have been directly involved in any regulatory action concerning the drug, according to FDA documents.

Currently, FDA advisory committee members may vote on a product's approval even if they participated in research on the product that was sponsored by the manufacturer.

Under the plan, the director of the Center for Drug Evaluation and Research, who is not normally involved in the approval of new drugs, would consider the board's recommendations as to a drug's safety and make the final decision on what would be posted on the Web site.

Drug Watch will operate in conjunction with the agency's MedWatch program, which discloses more definitive actions on a drug, medical device or nutritional product rather than on issues under discussion. Information posted on the Drug Watch Web site will be forwarded to physicians who have signed up to receive MedWatch alerts, said the FDA spokeswoman.