FDA Goes Behind Congress' Back

Bureaucratic Activism: FDA Ignores Congress to Let Drug Companies Off the Hook

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Dear (recipient name),

On January 16, 2008, the FDA issued a proposed rule which directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Unlike the FDA’s proposed rule, the legislation that pass Congress in September intended the duty to warn consumers 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, 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 new FDA rule, drug companies only will 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.

Congress needs to hold oversight hearings to curb this agency’s abuse of power for the following reasons:

1.)     The FDA has ignored expressed congressional intent.  
Although Congress clearly intended NOT to loosen the requirements on drug companies to inform consumers of potential drug hazards, the new FDA rule will give drug companies broad discretion to determine whether to warn consumers.

2.)     The proposed rule is a step backwards from making drugs safer.  
The new FDA rule will take power away from the FDA to require drug companies to warn consumers of potential problems with prescription drugs at the earliest possible time.  It will give drug companies the ability to choose not to inform consumers even if there is new evidence of a potential hazard.

3.)     The proposed rule will make it more difficult for consumers injured by prescription drugs to hold negligent drug companies accountable.  
Under the FDA’s new rule, the manufacturer will be immunized from accountability by claiming that it did not have sufficient evidence to require it to update its label.  Without the ability to hold the manufacturer accountable under the FDAAA for failure to warn, the consumer does not have any recourse for its injuries and could become a burden to taxpayers.

4.)     The FDA is contributing to a pattern of Bush Administration agencies ignoring clear congressional intent.  
For example, after Congress passed Public Law 110-53, which preserved railroad derailment victims’ rights, the Federal Railroad Administration issued a proposed rule which ignored Congressional intent.

I urge you to oppose the FDA’s attempt to usurp the authority of Congress.  You and your colleagues who were elected to Congress have the power to protect the health and safety of our citizens.

I encourage Congress to use its oversight authority to ensure that unelected bureaucrats do not go behind the back of Congress.  We must end this Bureaucratic Activism.

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