FDA Deputy Commissioner testifies before Congress on preemption

In testimony before Congress, FDA Deputy Commissioner for Policy Randall Lutter supported the preemption of state law liability claims involving FDA approved drugs and devices.

 

Lutter’s testimony reiterated the FDA’s position that its decisions about the safety and labeling of drugs and devices “should not be second guessed by state courts.” He stressed the laws and regulations of the FDA that authorize the agency to evaluate drugs and devices and the expertise and experience of the FDA in evaluating drug safety and efficacy.

           

The FDA evaluates the risks and benefits of drugs and devices for the population for which it is targeted, not every single individual that will use the device. To require the FDA to weigh the risks and benefits for each individual who would use the device would prevent the agency from approving more than a very few devices thus reducing the public’s access to valuable medical products, Lutter said. He noted physicians and patients must weigh the risks and benefits known about a product in relation to that individual patient’s circumstances. Even with the presence of risks, Lutter said it is still important for these products to be available to the public. State product liability lawsuits, if not preempted, could adversely affect public access to drugs and devices.

           

For example, Lutter referred to a decrease in vaccine manufacturers after several lawsuits in the 1970s. Similarly, he cited Dalcon Shield litigation as a cause for removal of similar devices from the market. Additionally, Lutter said state lawsuits could lead to product warnings that go beyond those required by the FDA. The need for additional warnings caused by state product liability lawsuits can create confusion and a disincentive to use the device or drug, he said.

           

The FDA does not seek to completely bar state product liability lawsuits, however. Lutter said state lawsuits would be appropriate where the drug or device manufacturer allegedly failed to follow FDA labeling and design requirements.