"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
To soften the blow, the agency's claim of federal preemption was included as a preamble to the long sought after new drug labeling guidelines. In response to the FDA's statement, Senator Edward Kennedy (D-MA) issued a statement of his own that said: "It's a typical abuse by the Bush Administration -- take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry."
The ploy was also readily recognized by state lawmakers and trial lawyers as another ploy to reduce the public's ability to hold Big Pharma accountable. "Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety," said Ken Suggs, president of the Association of Trial Lawyers of America.
According to Attorney Mark Labaton, a partner at the firm Kreindler & Kreindler, LLP, with offices in New York and LA, "the Administration's recent efforts to misuse federal rulemaking in the pharmaceutical and other areas to eviserate consumer rights is a big step backward."
"The new FDA rules to limit consumers' rights," he says, "are part and parcel of a larger effort to deny persons injured by unsafe products -- be they drugs, cigarettes or automobiles -- any form of redress."
He says its ironic that "an Administrative that calls itself "compassionate" and "conservative" consistently turns its back on "limited government" and "states rights" when it comes to protecting the rights of seriously injured consumers."
Upon learning of the FDA's power grab, the National Conference of State Legislatures, a bipartisan group that represents state lawmakers, accused the FDA of trying to seize authority that it did not have. The organization bases its opposition, in part on the following:
"FDA has usurped the authority of Congress, state legislatures and state courts. There is no statutory authority in the FDCA for FDA to preempt state product liability laws as they relate to prescription drugs.
"Instead of seeking valid congressional authority, unelected agency officials are seeking to preempt state product liability laws by writing this preemption into a final rule, thereby undermining state policy and judicial decision made in this area.
"State tort laws and civil justice systems serve as an important check on federal standards. Our civil justice system establishes a duty of care that protects citizens when the federal government is too slow to act or when federal standards are insufficient. States have the ability to achieve greater protections for their citizens through successful product liability lawsuits."
"Republican leaders added provisions to the conference report after cutting a back-room deal in the middle of the night. The conference report grants sweeping immunity to drug companies for injuries caused by vaccines and drugs and for the administration of those vaccines and drugs, even if they are made with flagrant disregard for basic safety precautions.
"Moreover, the compensation program is a sham, leaving people who become injured from a drug or vaccine without recourse.