U.S. drug makers up in arms over info on FDA "Drug Watch" web page

Aug 9 2005

Pharmaceutical companies in the United States are up in arms over plans by U.S. regulators to release preliminary information, about the potential side effects of drugs.

The drug manufacturers say that the action could lead to unnecessary confusion and "irrational fears" about drugs.

The proposed "Drug Watch" Web page by the Food and Drug Administration (FDA), would apparently list safety concerns about drugs being evaluated by the agency.

According to the drug industry's U.S. lobbying group,the Pharmaceutical Research and Manufacturers of America (PhRMA), the information the FDA is aiming to publicize "is too vague and preliminary", to be of value in making informed treatment and prescribing decisions, and is unlikely to accomplish anything other than create more confusion among physicians and the public.

PhRMA is arguing that the release of early information may violate a law requiring data released by federal agencies to be useful, and it also suggests the plan may exceed the FDA's authority.

PhRMA President Billy Tauzin says they are concerned that bad information gets into the system, and people stop using drugs they need.

The FDA is yet to comment.

The Web page was proposed by regulators after charges that FDA officials suppressed concerns by staff scientists concerning drugs such as Merck's arthritis pill Vioxx. The company were forced to recall Vioxx in September 2004 amid mounting evidence of links to heart attacks and strokes.

At the time the FDA promised in future to release information sooner, including posting it on the Drug Watch page.

PhRMA has also voiced it's concern that the FDA may not provide companies with sufficient notice of new information for the Web site, or give them the opportunity to make an input.

According to the FDA's Web site, www.fda.gov, it wants to make sure patients "have quick access to the most up-to-date and emerging product information" for making treatment decisions.