Plan would Limit Drug Label Warnings, Risk Information

Some lawmakers are pleading with the FDA to scrap a plan that changes labeling rules on drugs and medical devices. The lawmakers say the plan, which would greatly limit the language about product instructions and side effects, would shield drug makers in future lawsuits because they could claim that regulations did not allow them to adequately address warnings or risk information properly.   

Specifically, the Reuters article reads:

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.

The lawmakers are right. This is a bad plan which seems to purposefully allow drug makers to wriggle out of future court decisions against them. It is also palpable how instituting guidelines which limit drug warnings and risk language is not in the best interest of consumers and can have terrible results.

-- Dylan Blaylock