by Robert A. Schwartz, Attorney at Law

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.

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 back 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 a label update. Without the ability to hold the manufacturer accountable under Congress’act, the consumer cannot seek recourse for 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 that sought to provide immunity to negligent railroad companies in the event of a commuter train derailment.

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.