The FDA and the pharmaceutical industry have been in strong negotiations on this latest version of the PDUFA to decide how much drug companies will pay the agency to review new drugs from the end of this year, when the current law expires. On 16 February, the FDA held a public hearing to announce updates to its program.
Congress will decide later this year if it is worth renewing the program for another five years. The extra funds generated from the fees have allowed the FDA to hire more reviewers to cut review time but opponents worry that companies might be seen as 'buying' the FDA.
The program has cut the average reviewing time of 30 months to six months for priority applications, or 12 months for standard applications. Moreover, the extra funds have helped to clear the backlog of pending reviews.
"What has been altered [in this program] is the level of resources available for FDA to perform its critical function of reviewing safety and effectiveness of potentially life-saving medications," Alan Goldhammer, deputy vice president for regulatory affairs at Pharmaceutical Research and Manufacturers of America (PhRMA), told US-PharmaTechnologist.com.
"With more resources provided by PDUFA, FDA has been able to completeits rigorous reviews more quickly and efficiently. The outcome of this review, however, is not affected by PDUFA funding and may or may not be a drug approval. That decision is the FDA's based on the information in the license application."
In addition, the program has played a key part in patient safety, as a portion of the funding was dedicated to improving the trade name review process. The FDA wants to ensure that new trade names are not confused with existing trade names, which can lead to medication errors.
"The FDA will now have additional resources to review trade names during drug development and provide industry with guidance on 'good naming practices.' This will improve the predictability of the trade name review process," said Goldhammer.