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 also is proposing to create a separate program to collect fees from companies that want their direct-to-consumer television ads reviewed by the agency.
The FDA published its proposals in the Jan. 11 Federal Register and planned to collect comments on them at a public meeting on Feb. 16. The final proposal will be sent to Congress later this year, said Jane Axelrad, associate director for policy at the Center for Drug Evaluation and Research (CDER), in a teleconference sponsored by the FDA.
Time is of the essence, as 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, CDER director, during the 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, adding that he could not say whether that would hold true going forward, since the agency has not yet received its appropriation for fiscal 2007 or a budget for fiscal 2008.
However, Ms. Axelrad said that drug user fees represent an increasing proportion of CDER's budget.
Public Citizen's Health Research Group criticized that trend, saying that the agency should not receive so much of its funding from the industry it regulates.
“The FDA's crucial drug regulatory functions are too important to be tainted and compromised by direct funding from the very companies whose drugs the agency reviews for safety,” said Dr. Sidney Wolfe, director of the advocacy group, in a statement.
The biotechnology and pharmaceutical industries praised the FDA proposal.
“The PDUFA recommendations announced today are a win-win,” said Jim Greenwood, president and CEO of the Biotechnology Industry Organization, in a statement. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs.”
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. Sheila Mullin, FDA assistant commissioner for planning, said that in fiscal 2005, the agency held 1,800 formal meetings at manufacturers' request.
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.
“Reviewing data electronically helps to improve the efficiency of the drug approval process and expedites getting important new drugs to the patients who need them,” said Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, in a statement.
The agency is proposing to create a new user fee program solely 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.
The FDA anticipates charging $6 million in the first year of the program, which would subsidize the hiring of 27 new employees. Another $6 million would be collected for a reserve fund, to cope with unanticipated increases in volume of advertisements.
PhRMA lauded the new program.
“The FDA would have more resources to develop comments for companies before their ads are broadcast, which would help to ensure the advertising's accuracy, balance and compliance with all regulatory requirements,” said Mr. Tauzin.