Federal lawmakers said they want the Food and Drug Administration to better monitor the safety record on drugs after they are on the market, make its approval process more transparent and more closely regulate direct-to-consumer pharmaceutical marketing as part of the reauthorization of the Prescription Drug User Fee Act, or PDUFA, which is set to expire Sept. 30.
The program, which established a user-fee system where drug manufacturers provide a revenue source to the FDA to speed the review of new drug and biologics applications, is widely considered a success. The additional money the FDA receives from the drugmakers has allowed the federal agency to increase the size of its workforce and speed up the time it takes for new drugs to get to the market.
But lawmakers cautioned that faster isnt always better. Rep. Frank Pallone (D-N.J.), chairman of the House Energy and Commerce Committees Health Subcommittee, said that there are legitimate concerns that in the rush to speed drugs to market, We could be overlooking critical safety issues and place patients at risk.
Theresa Mullin, assistant commissioner for planning at the FDA, said the agency wants PDUFA fees increased by $87.4 million per year, which would give the FDA roughly $437.8 million in user fees in fiscal 2008. Mullin told lawmakers that the FDA also wants to enhance its process for pre-market reviews of drugs and modernize its post-market drug-safety system.
Additionally, the FDA has proposed that a new and separate user fee be charged to those companies that intend to seek FDA advisory reviews of direct-to-consumer television advertisements. The FDA said the program would give them about $6.25 million in annual fees during the first year. -- by Matthew DoBias