DATA OVERLOAD COULD LESSEN IMPACT OF DRUG WATCH

The FDA' proposed Drug Watch website may not pack the punch that many pharmaceutical companies fear, according to one financial analyst.

Drugmakers have expressed concerns that the Drug Watch, which will house emerging safety information about drug products, could cast a manufacturer in a negative light if information about one of its products is posted on the website. Such concerns, however, may not surface because the site is likely to be too voluminous to make individual product safety warnings stand out, David Risinger, a research analyst with Merrill Lynch, writes in a recent research note.

"Data overload could dilute the impact of the Drug Watch," Risinger writes. "Investors should note that FDA public postings/documents tend to provide large amounts of data without necessarily providing the agency's interpretation of the data. Unless the agency specifically highlights information within Drug Watch as 'new' and 'concerning,' an increase in public disclosure may not have much of an impact on physician, patient or investor perception."

The fact that the FDA has already started posting emerging safety information on an interim website could also minimize the effect of the Drug Watch, Risinger notes. In May, the agency unveiled a "Drug Specific Information" web page that provides access to safety information on roughly 250 approved drugs. The FDA has been releasing emerging safety data on the website -- http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm (http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm) -- in advance of the pending Drug Watch launch.

The Drug Watch, announced in February as part of the agency's effort to boost drug-safety oversight, has drawn strong criticism from the drug industry. In recent comments to the FDA, PhRMA argues that listing such information "not only is of little or no help in guiding prescribing or treatment decisions, but also is potentially misleading when presented on an official FDA Drug Watch website."

But as of early summer, the FDA was still grappling with the threshold it would use for listing a drug. The FDA has heard that the threshold should be low, "so that every signal would not necessarily raise huge alarm bells," said Susan Cummins, medical team leader of CDER's division of pediatric drug development, at the Biotechnology Industry Organization's annual conference in Philadelphia. "It would be just part of the background of information gathering in the practice of medicine," she said. On the other hand, the FDA has heard suggestions that the threshold should be high, she said.