Democrats object to plan on drug label changes

WASHINGTON (Reuters) - Eight U.S. congressional Democrats urged the U.S. Food and Drug Administration on Wednesday to reconsider a plan that the lawmakers said would shield companies from liability rather than protect patients.

The FDA earlier this month proposed changing the rules governing the type of information that drug and medical-device makers can add to product labels without agency approval.

The Democratic lawmakers said the agency's plan would sharply limit what manufacturers could add quickly to their prescribing instructions about potential side effects. Companies could not unilaterally add a new warning unless there was "evidence of causal association," the lawmakers said.

The proposal "is apparently designed to bolster the argument by companies defending against lawsuits that the regulations precluded them from adding" warnings or information about risks, the lawmakers said in a letter to FDA Commissioner Andrew von Eschenbach.

"The agency's proposed rule protects the profits of the pharmaceutical and medical device companies rather than the health and safety of American consumers," the letter said.

FDA spokeswoman Rita Chappelle said the agency would respond to the lawmakers.

The letter was signed by Reps. Henry Waxman, John Dingell, Frank Pallone, Rosa DeLauro and Edward Markey, and Sens. Edward Kennedy, Patrick Leahy and Christopher Dodd.

The Pharmaceutical Research and Manufacturers of America, an industry group, is reviewing the FDA proposal and will submit comments to the agency, spokesman Ken Johnson said.

FDA experts are "the most qualified to make such highly scientific and technical judgments about pharmaceutical benefits, risks and appropriate communication of those risks," Johnson said in a statement.

(Reporting by Lisa Richwine and Kim Dixon, editing by Richard Chang)