Feb. 6, 2008
On Jan. 16, 2008, the Food and Drug Administration issued a proposed rule that directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendments Act of 2007 (FDA Amendments Act of 2007).
The act bestows the responsibility to warn consumers of a drug’s hazards on the drug company, which is in the best position to do so. 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 act, passed just four months ago, 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 FDA rule, drug companies will have to revise their warning label only when 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.
Congress must hold oversight hearings to curb the FDA’s abuse of power for the following reasons.
Congress must act to investigate the FDA’s attempt to usurp the authority of Congress to protect the health and safety of constituents. By using its oversight authority, Congress must ensure that unelected bureaucrats are not ignoring explicit congressional intent and must end this bureaucratic activism.
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