US pharma and FDA near agreement on PDUFA reauthorization, with 6% hike in user fees

After many months of negotiations with the Food and Drug Administration, the USA’s pharmaceutical industry is close to agreeing reauthorization of the Prescription Drug User Fee Act (PDUFA), last updated in 2007, for a further five years, with a draft agreement published by the FDA last week.

Under the draft accord, the FDA has agreed to PDUFA V recommendations that will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science and strengthen post-market surveillance. For its part, the industry – which provides some 60% of the FDA’s drug review costs - has accepted a 6% rise in user fees to finance the agency’s operations.

The increase is expected to add $40.4 million to user-fee revenue in fiscal 2012, bringing the fiscal 2013 total to $712.8 million, Karen Riley, a spokeswoman for the FDA, said in an e-mail to the Bloomberg news service. The agency in turn will have to meet with companies in the midst of reviews to raise concerns and ensure that evaluations are carried out in a timely way, said Bloomberg.