Avalere: FDA fees are outpacing drug approvals
- Consulting firm Avalere Health released a report this week showing more than $7.9 billion has been collected in fees from drug makers by the U.S. Food and Drug Administration since 1992.
- The report found that close to $300 million in fees have gone unspent, with Avalere suggesting the agency should use the unspent fees to accelerate the approval time of drugs.
- Approximately 68% of the branded drug and 58% of the generic drug review budget come from user fees, said the report.
The Prescription Drug User Fee Act (PDUFA) was established to help directly fund the FDA review of drugs and decrease the time it takes for a drug to get to market. While approval times have dramatically decreased, Avalere Health argues that the $300 million in unspent fees should be used to accelerate approval timelines further.
"The significant unspent funds left over from user fee programs suggest that FDA could do more to accelerate product reviews," Jay Jackson, manager at Avalere, said in a statement. "Particularly with public concern around drug prices, speeding approval of the second-to-market products can increase competition that may result in lower net prices."
There are currently multiple types of prescription drug user fees, including product fees that are paid for marketed products; establishment fees that are paid by all manufacturers annually; and application review fees that are paid when an application is submitted.
Fees have been steadily rising. In 2016, a prescription drug application that includes clinical data has an application fee of more than $2.3 million to the FDA.
45 novel drugs were approved in 2015, significantly more than in previous years when the average number of novel drugs approved was 28.
The current PDUFA program is set to expire in September 2017 and negotiations for PDUFA VI are already underway. The agency recently outlined expectations for the reauthorization of PDUFA that will include incorporating patient voice in drug development, enhancing the use of real-world evidence, reducing the administrative burden associated with approval, early consultation on surrogate endpoints and even slowing the increase of user fees.
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