The FDA should be empowered to enforce a two-year ad ban for new drugs, according to a report by the nonprofit Institute of Medicine (IOM).
The IOM report, commissioned by the FDA in the wake of the withdrawal of Merck’s Vioxx in late 2004, found that the FDA’s drug safety system is impaired by “serious resource constraints” and burdened by an organizational culture that is “not optimally functional.”
The IOM committee said the FDA must work to fix the “perception of crisis,” which has compromised agency and pharma industry credibility.
The IOM also recommended that Congress enact legislation to establish a new FDA advisory committee on communications. “This new committee would be composed of members who represent consumer and patient perspectives and organizations,” IOM said.
Acting FDA commissioner Andrew von Eschenbach reacted to the report by explaining that, “while considerable work has been done over the past two years to improve our approach to drug safety, work still remains to be done.”
Steven Galson, director of the FDA’s Center for Drug Evaluation and Research added coolly, “the spirit of the report resonates with many of us, even if some have questions regarding specific recommendations put forward by the IOM.”
The industry trade group PhRMA questioned whether an overhaul of the FDA’s drug safety system is really necessary at all.
PhRMA SVP Caroline Loew said, “Though there is always room for improvements, it would be a mistake to accept the notion that the FDA drug safety system is seriously flawed. After all, fewer than 3% of approved prescription drugs have been withdrawn from the American market for safety reasons over the last 20 years.”
Reaction to the report from the Coalition for Healthcare Communications (CHC) was mixed.
“The IOM report recommends another significant step forward by naming and tasking a new office of drug safety with a major communication role,” said CHC executive director John Kamp. “However, the group’s specific proposal for a two-year DTC blackout clearly violates the First Amendment.”