FDAnews Drug Daily Bulletin


Dec. 6, 2005

The FDA is planning to consult with risk communication specialists to help it enhance its Drug Watch proposal to ensure that doctors and patients are not confused by the data posted to the website, but industry critics say this approach, while a step in the right direction, would not alleviate their concerns.

FDA Deputy Commissioner Scott Gottlieb told FDAnews recently that the agency is prepared to "take a hard look" at the Drug Watch in response to a flood of industry criticism and threats of legal action. As part of its review, the agency will hire risk communication experts to help it effectively communicate whether information posted to the site represents a confirmed or a potential risk.

"We want to make sure that doctors and patients are not confused," Gottlieb said during FDAnews' Second Annual FDA Information Management Summit in Bethesda, Md. Specifically, the FDA does not want doctors to think there is more evidence about a drug's potential risks than really exists. But Gottlieb cautioned that the agency is still reviewing its options and has not decided exactly how it will proceed.

Industry officials applauded the agency's willingness to readdress the Drug Watch, but they still believe that unconfirmed safety data shouldn't be released in a public forum, like the FDA's proposed website. If the FDA feels that a disclaimer is necessary for the Drug Watch, then the data should not be released in the first place, said PhRMA Assistant General Counsel Scott Lassman.

While the FDA has argued that it is merely publishing data that private groups can obtain through a Freedom of Information Act request, the Drug Watch goes a step further, Lassman said. Posting safety data on an agency-operated website "puts an FDA stamp of approval" on the information and "no amount of disclaimers will erase that problem," Lassman said. PhRMA and other critics fear that the Drug Watch data will be used by plaintiffs' attorneys as proof of material safety risks, leading to more product liability lawsuits.

Industry officials have also blasted the proposed site for being inconsistent with federal law. Specifically, PhRMA and other groups have argued that the Federal Food, Drug, and Cosmetic Act and the FDA's implementing regulations establish labeling as the primary means of communicating information about a prescription drug product, including safety-related information.

Additionally, industry attorneys, including former FDA chief counsel Dan Troy, have argued that the site could be challenged under the Data Quality Act because the agency lacks the necessary scientific proof to make pronouncements about potential risks.