Friday, February 24, 2006

Democrats urge FDA to reverse label liability

Democrats urge FDA to reverse label liability

WASHINGTON (Reuters) - A Food and Drug Administration position that federally approved prescription drug labels are not subject to state liability laws should be reversed, Democratic lawmakers said on Thursday.

In a letter to Health and Human Services Secretary Mike Leavitt, whose department includes FDA, Rep. Henry Waxman of California and other lawmakers said the policy protects drugmakers from lawsuits and was enacted without public comment.

The FDA issued the controversial policy last month as part of new rules to simplify long and often hard-to-read drug labels. It said drugmakers were concerned that simpler labels would open them up to lawsuits.

The FDA-approved prescribing information "whether it be in the old or new format, pre-empts conflicting or contrary state law," the agency wrote at the time.

Agency officials have said the language simply restated their position in state lawsuits against drugmakers.

The lawmakers said the decision failed to take into account numerous hurdles to revise drug labels when new risks emerge.

"Unfortunately, important information about how to use the drug safely and effectively that is developed after approval is not always added to the drug's label in a timely way," wrote Reps. Waxman, John Dingell of Michigan and Sherrod Brown of Ohio.

In a second letter to Leavitt, Massachusetts Sen. Edward Kennedy and Connecticut Sen. Christopher Dodd questioned why the FDA "completely ignores" Congress' intent to allow states to take liability action even under federal law.

In both letters, lawmakers said the agency's proposed version of the rule, issued in December 2000, said FDA labeling would not pre-empt state law.

FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb defended the agency's decision, saying "it was not at all a total reversal." But he added that he had not read the letters.

HHS spokesman Bill Hall confirmed that the department received the letters and declined further comment.