Dangerous Drugs–Who Is The FDA Trying To Protect?

In January of this year, the FDA issued a proposed rule which directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendment’s Act of 2007 (FDAAA). Unlike the FDA’s proposed rule, Congress intended the duty to warn customers of a drug’s hazards rests with the drug company, who is in the best position to warn about problems associated with the drug. However, under the FDA rule, drug companies will enjoy more relaxed labeling requirements and will use the rule to claim immunity for failing to warn patients of potential drug hazards. The FDAAA requires a drug company to update its label to include drug hazard warnings as soon as there is reasonable evidence of that risk. This law allows consumers to be aware of a drug’s potential risks at the earliest possible moment and prevents injuries and deaths such as those associated with Avandia and Vioxx. However, under the new FDA rule, drug companies will only have to revise their warning label where they establish “sufficient evidence of a causal association” which could take years. This is a significantly higher standard that drug companies would have to meet before informing consumers of a potential hazard. It is imperative that Congress hold oversight hearings to curb this agency’s abuse of power because the FDA has ignored expressed Congressional intent and this proposed rule will not serve to make drugs safer. Instead the proposed rule will make it more difficult for consumers injured by prescription drugs to hold negligent drug companies accountable.