FDA proposes rule holding prescription drug companies less accountable than recent federal law intended

The FDA has proposed a rule in direct contradiction to a law passed by Congress that helps hold negligent drug companies accountable for injuries to consumers caused by prescription drugs. Congress passed the Food and Drug Administration Amendments Act (FDAAA) recently which holds drug companies responsible for promptly updating drug labels when they become aware of new safety information. The new rule being proposed by the FDA will relax labeling requirements so that drug companies can use it to claim immunity for failures to warn patients and consumers of drug hazards. This is a form of bureaucratic activism, where unelected agencies like the FDA ignore the will of Congress. If the drug companies are not held accountable for failure to warn, unnecessarily injured consumers will not be able to win compensation from them and the burden will be transmitted to taxpayers.

and urge them to investigate the FDA’s attempt to upsurp Congress’s authority to protect the health, safety and wellbeing of their constituents.

Lawyer Monthly - Legal Awards Winner
The National Trial Lawyers
Elder Care Matters Alliance
American Association for Justice
Fellow Litigation Counsel of America
Super Lawyers
Contact Information