Drug makers object to U.S. plan for early warnings

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Plans by U.S. regulators to release preliminary information about potential drug side effects could lead to unnecessary confusion and “irrational fears” about medicines, drug makers said on Monday.

The Food and Drug Administration (FDA) has proposed a “Drug Watch” Web page that would list drug safety concerns that are being evaluated by the agency.

The drug industry’s U.S. lobbying group said the information the FDA was aiming to publicize “is too vague and preliminary to be of any value in making informed treatment and prescribing decisions.”

"Such information is… not likely to accomplish anything other than confusion among physicians and the public and creation of irrational fears about the safety of drugs on the list,” the Pharmaceutical Research and Manufacturers of America (PhRMA) said in written comments to the FDA.

Releasing early information may violate a law requiring data released by federal agencies to be useful, PhRMA argued. It also said the plan may exceed the FDA’s authority.

“There’s a deep concern that bad information gets into the system… and people stop using drugs they need,” PhRMA President Billy Tauzin told Reuters. But, he added, “I’d rather have them (FDA) doing it than some blogger” on the Internet.

An FDA spokeswoman did not immediately respond to a request for comment.

Regulators proposed the Web page after charges that FDA officials suppressed concerns by staff scientists about medicines including Merck & Co. Inc.’s arthritis pill Vioxx. The company recalled Vioxx in September 2004 amid mounting evidence of links to Heart Attacks and Strokes.

FDA officials promised to release more information sooner, including posting it on the Drug Watch page.

PhRMA also voiced concern that the FDA may not provide companies with adequate notice of new information for the Web site or a chance for input.

The FDA said on its Web site, http://www.fda.gov, that it wanted to make sure patients “have quick access to the most up-to-date and emerging product information” for making treatment decisions. 

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