Led by FDA critic Bart Stupak, 17 members of the House Energy & Commerce Committee wrote a letter to FDA Commish Andy von Eschenbach to ask that the agency withdraw itsrecently proposed rule allowing drugmakers to make changes on their product labeling. As they see it, the rule would set a new standard leading to fewer warnings by drugmakers, longer agency reviews and delays in communicating problems to consumers.
"We have profound concerns with these changes. It is unclear why an agency that is clearly in crisis would seek to limit consumers’ access to information about crucial health and safety risks," the wrote. "....We believe the FDA’s proposed rule directly contradicts this language by reversing a drug manufacturer’s obligation to warn of new risks and hazards and, instead, allowing these companies to claim immunity from liability because they had no duty to warn. This is contrary to congressional intent and to the FDA’s mission to protect the public health." This is the letter.
At issue is preemption. Pharma has been arguing that FDA labeling should trump state court judges and juries because the agency's actions are the final word on safety and effectiveness, which is found in the labeling. And if drugmakers have less latitude to make changes, they can use FDA regs as a defense.
Earlier today, the US Supreme Court left intact a ruling that allows product-liability suits against drugmakers in Michigan to proceed if plaintiffs can show that a drugmaker misrepresented or withheld info from the FDA that would have prevented the agency from approving the drug. A broader preemption case will be heard this fall. You can read about this here.
Besides Stupak, those signing the letter include Gene Green; Lois Capps; Jay Inslee; Jan Schakowsky; Maurice Hinchey; Diana DeGette; Mike Ross; Charlie, Melancon; John Barrow; Eliot Engel; Tammy Baldwin; Anthony Weiner; Michael Doyle; Tom Allen; Hilda Solis; and GK Buttefield. This is the second time that a group of lawmakers has written the FDA to complain about the proposed rule.