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For Immediate Release:  March 17, 2008

Contact:  Ray De Lorenzi
202-965-3500 x369
AAJ Press Room

AAJ URGES FDA TO PUT PATIENT SAFETY FIRST
Agency continues to defy Congressional intent

Washington, DC – The American Association for Justice today sent comments to the Food and Drug Administration (FDA) concerning a proposed rule that would give immunity to drug companies for failing to warn patients of potential drug hazards.

This rule directly contradicts Congressional intent that drug manufacturers have a duty to warn the public about potential problems when they become aware of drug risks.

"This proposed FDA rule is a giant step backward for patient safety," said AAJ President Kathleen Flynn Peterson. "Not only will it keep patients in the dark about the safety of their prescriptions, but will also shield companies from being held accountable for their negligence."

A new law enacted last fall (the Food and Drug Administration Amendments Act of 2007) required drug companies to update prescription drug labels to warn consumers of hazards at the earliest sign of a problem. However, under this FDA rule, drug companies would only have to update its label after they establish a "causal association" between the drug and the hazard, which could take years.

"The FDA's own science board has said they are incapable of protecting Americans against unsafe drugs, medical devices, and food," said Flynn Peterson. "When drug companies can bypass Congress and let the agency do their bidding, it's questionable if public health is the FDA's number one priority."

In addition to this FDA rule, federal agencies have a pattern of ignoring clear congressional intent through preemption and protecting companies over consumers. A few examples include:

• Food and Drug Administration: In 2006 the FDA angered both Democrats and Republicans in Congress by issuing a drug labeling rule that preempted state law despite the fact that the agency had long held the opposite view. Senators Kennedy and Dodd, senior Democrats on the committee that oversees the FDA, criticized the agency for adding the language without allowing comments, and described the assertion of preemption as "a drastic reversal of policy with … far-reaching implications."
• Federal Railroad Administration: Just four days after Congress passed the Implementing Recommendations of the 9/11 Commission Act of 2007 that preserved railroad derailment victims' ability to hold railroad companies accountable for their injuries, the Federal Railroad Administration also issued a proposed rule which sought to provide immunity to negligent railroad companies in event of a commuter train derailment.
• Department of Homeland Security (DHS): DHS claimed preemption of state laws in a 2006 rule regarding chemical facility safety. The rule left state and local communities with the responsibility for any necessary clean-up and emergency response, despite the fact that the Senate Homeland Security and Governmental Affairs Committee expressly rejected such an approach just a year earlier. Senators Lieberman, Collins and Lautenberg, admonished DHS Secretary Michael Chertoff for the failure to recognize, or even discuss, the fact that Congress never intended state laws to be preempted.
• National Highway and Traffic Safety Administration (NHTSA): In 2005, the NHTSA proposed rules on seatbelts and roof-crush resistance that would preempt state common-law claims. The move sparked criticism from Senators Specter and Leahy. A senior NHTSA official involved in the roof-crush rule later told the Los Angeles Times that the preemption issue had been handled in a way "different from how we normally operated… [The rule] was dropped in from out of the blue."