FDA Proposes Higher User Fees From Drug Manufacturers

By Alicia Ault 

The Food and Drug Administration on Jan. 11 proposed greatly increasing the fees its drug division collects from pharmaceutical manufacturers, saying that current fees collected under the Prescription Drug User Fee Act have not kept pace with inflation or the agency's growing workload.

Most of the additional money would be used to upgrade the agency's postmarketing drug safety monitoring.

The FDA published its proposals in the Jan. 11 Federal Register and collected comments on them at a public meeting on Feb. 16. The final proposal will be sent to Congress later this year. The deadline is approaching; PDUFA--first established in 1992 and reauthorized in 5-year increments--is due to expire on Sept. 30, 2007.

Under PDUFA, the FDA charges prescription drug makers a set fee to review the safety and efficacy of products submitted under a new drug application. In return, the agency has to meet deadlines for review and approval.

The law has helped FDA to reduce review times and increase its postmarketing oversight, said Dr. Steven K. Galson, Center for Drug Evaluation and Research director, during a teleconference.

Under the new proposal, FDA seeks to collect $393 million annually, $87 million more than it currently takes in each year. Drug user fees account for about half of CDER's budget, said Dr. Galson.

The largest portion of the increase, $29 million, would be devoted to postmarketing safety. With those funds, the agency said it could hire 82 new employees, and acquire the best tools and databases for improving the detection and analysis of safety signals.

The agency also will institute new programs to reduce medication errors, in response to an Institute of Medicine report issued in September 2006 calling for drug safety improvements at the agency.

Some $20 million would go to cover expenses incurred in the last few years to facilitate drug makers' requests for formal meetings about their products.

About $4 million would be devoted to improving information technology for drug reviews, with the goal of moving to "an all-electronic environment," according to the FDA proposal.

FDA is also proposing to create a new user fee program to fund the review of direct-to-consumer television ads. Currently, companies can voluntarily submit their ads for review, but the FDA has not been able to keep up with the growing workload, said Dr. Galson.