The Food and Drug Administration (FDA) has proposed that drug companies should not be able to change warning labels to alert consumers about potential unsafe conditions with their products without first receiving FDA approval. The proposal would be a deviation from current practices that allow drug companies to warn consumers without prior FDA approval.

Why the change?

That’s exactly what Democrats are asking. Several Democrats, including Reps. Henry Waxman (D-Calif.), John Dingell (D-Mich.), Frank Pallone (D-N.J.), Rosa DeLauro (D-Conn.), Ed Markey (D-Mass.) and Sens. Edward Kennedy (D-Mass.), Patrick Leahy (D-Vt.) and Chris Dodd (D-Conn.), say that there is no reason for the change – except to insulate drug companies from potential lawsuits. Current regulations allow drug companies to strengthen warnings without FDA approval to protect patients and consumers. Under the proposed regulations, drug companies could not do so unless there is “evidence of causal association” between the drug and potentially harmful conditions. The bottom line is that the proposed regulations would result in fewer warnings being issued to consumers.

Letter to FDA’s Commissioner

In a recent letter to FDA Commissioner, Dr. von Eschenbach, Democrats stressed that the regulations, known as the ‘changes being effected (CBE) supplements’, serve the vitally important public health function of ensuring that patients and healthcare providers are made aware of safety risks associated with their medical products at the earliest possible moment.

Democrats also expressed their concern by saying, “We are concerned that the intent of this proposal is to protect companies in the pharmaceutical and device industry from being held liable for marketing products they know are unsafe. Such a policy change comes at the expense of consumers and violates the mission of the FDA. Given that FDA failed to identify a public health basis for why this lengthy proposal was necessary at this point in time, the letter’s authors ask FDA to answer questions justifying the expenditure of the agency’s limited resources on this effort.”

The group requested that the Commissioner provide a response to their concerns by February 13, 2008.

To view the letter written to Dr. von Eschenbach, go to the newsroom section of Senator Kennedy’s website at: http://kennedy.senate.gov/.