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COLOR-CODED RISK SCHEME URGED FOR FDA'S DRUG WATCH

June 29, 2005

The FDA should take a proactive approach in communicating emerging drug-safety information on the proposed Drug Watch website, according to a pharmaceutical industry observer.

While many consumers visit the FDA website, they may not be aware of the new Drug Watch page or may not visit it often enough, said John Mack, owner of Pharma Marketing Network, which includes an online forum of pharmaceutical marketing, advertising and sales professionals.

"Rather than relying on a 'build it and they will come' strategy, the FDA should take a more proactive approach like it has with the traditional MedWatch program, which notifies doctors about drug-safety issues," Mack said in response to the FDA's draft guidance on the Drug Watch site issued in May.

The purpose of the Drug Watch is to communicate significant emerging safety information about specific drug products or classes of drug products, according to the guidance. This emerging safety information may relate to new risks, new information on known risks or risks associated with off-label uses, the FDA said.

Taking the MedWatch approach, the FDA could drive the proper segment of the population to the Drug Watch site, he said. For example, MedWatch requires pharmaceutical firms to send "Dear Doctor" letters to their physician clients, and it enlists professional organizations and websites focused on physicians to notify members and visitors about the notices. The same strategy could be applied to the Drug Watch, Mack said.

The FDA is accepting public comments on the Drug Watch through early August. The draft guidance and public comments can be viewed online at http://www.fda.gov/ohrms/dockets/dockets/05d0062/05d0062.htm (http://www.fda.gov/ohrms/dockets/dockets/05d0062/05d0062.htm).