The biopharma industry, in talks this year with the FDA over user-fee laws set to be renewed by Congress, is said to be nearing agreement on a package of recommendations.
“The hope is that we come up with a framework that not only improves the ability of FDA to move expeditiously, but also to move in a way that provides more certainty,” said John Castellani, president and CEO of trade group PhRMA. “It has the expertise to be able to understand the science that fuels our development.”
Congress is spending a lot of time this year on reauthorization of the Prescription Drug User Fee Act (PDUFA), which requires drug and device companies to pay user fees to the FDA for reviewing their products. Hearings are expected to heat up as the agency's deadline for sending recommendations to Congress, January 2012, approaches.
Castellani, speaking at the New York Biotechnology Association (NYBA) meeting last week, said he hoped to hammer out a set of PDUFA recommendations with BIO (the Biotechnology Industry Association) and the FDA in time for PhRMA's 2011 Annual Meeting, which starts Wednesday in Jersey City, NJ. “We're nearing the end of the negotiations with our counterparts in BIO with the FDA, and we hope that we will have an [agreement] that we can bring to the PhRMA board…when we meet across the river in Jersey City.”
Procedures call for the FDA to put those recommendations into a request to Congress. Congress then uses that as a first draft of the next PDUFA bill.
“The chairs in the House say they would like to move the legislation quickly and cleanly,” said Castellani. “The Senate will be a different story. We expect that since this is a healthcare legislation bill that must be passed, that a lot of other things will be added on.”
These could include changes to the FDA's proposed revisions to the 510(k) process for approving most medical devices and provisions aimed at bringing generic biologics to market, among other legislative measures. The last PDUFA reauthorization, which came in 2007, brought changes to drug advertising and vested the FDA with new powers to policy drug safety.
PhRMA's focus is on consumer access to medical products. “PDUFA provides us with a great opportunity to enhance the regulatory system and to improve the science and technology expertise that is needed to review medicines,” said Castellani, “but it also gives us an opportunity to look at greater efficiencies to help move innovative medicines and treatments through review and to approval for patients' use.”
Last year the review process proved frustrating for several companies. The agency delayed decisions on AstraZeneca blood-thinning drug Brilinta, MannKind's inhaled-insulin product Afrezza and Benlysta, the lupus drug from Human Genome Sciences and GlaxoSmithKline. (Benlysta finally secured approval from the agency in March.)
Castellani also discussed PhRMA concerns with last year's sweeping healthcare overhaul. Of short-term concern to industry is a provision in the Affordable Care Act known as the Independent Payment Advisory Board. It's charged with slashing Medicare spending, and that could result in restrictions in access to medicines among seniors, said Castellani, adding that the measure should be repealed.