FDA REJECTS DRUG SAFETY BILL'S RISK MANAGEMENT PLAN PROVISION
The long-awaited effort to overhaul the nation's drug safety efforts faces FDA opposition as agency officials reject a recent legislative proposal to improve risk management plans as "unrealistic." But at least one congressional source dismissed the criticism.
The "Enhancing Drug Safety and Innovation Act," drafted by Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Mike Enzi (R-Wyo.) and ranking member Edward Kennedy (D-Mass.), is meant to improve the FDA's oversight of drugs once they are on the market and imposes on the industry new safety planning requirements before launching a drug. It also establishes a national clinical trial registry.
The bill would require the FDA to approve drugs and biologics as well as new indications for these products under a Risk Evaluation and Mitigation Strategy (REMS), a mechanism to acquire and adapt to new safety information about a drug. Every risk plan would include 15-day, quarterly and annual adverse event reports, FDA-approved labeling and a pharmacovigilance statement that explains and justifies whether standard adverse event reporting is adequate, or if more studies and clinical trials are needed.
But one FDA official, who asked not to be named, is rejecting this proposal. The REMS program unnecessarily slows the drug review process, removes agency discretion to tailor risk management reviews for individual drugs and places unreasonable deadlines and financial burdens on the agency, the source said. These concerns are shared by a number of other FDA officials, the source added.
"The timelines for achieving goals under the legislation are unrealistic, and the resources that it would require would add significant new burdens and financial strains on FDA," the source said. "It's a very bureaucratic solution to a very practical problem."
But these comments are merely "pot shots from faceless, nameless FDA talking heads," Enzi spokesman Craig Orfield said. "A 'very bureaucratic response'? Frankly, this criticism is the textbook bureaucratic response of the year."