FDA funding agreement with drugmakers expected Thursday

The Food and Drug Administration is expected to make public on Thursday an agreement with drugmakers to fund the agency for the next five years.

Industry sources say they don't expect any surprises when the Prescription Drug User Fee Act (PDUFA) recommendations are published in the Federal Register, kicking off a public comment period before the proposal is sent to Congress for approval. 

A preliminary agreement struck in May between the agency and drugmakers calls for a $100 million increase in fees to pay for more than 100 extra staff members, two more meetings with sponsors during the drug review process and a two-month extension of the review time for new drugs.


"We don't anticipate any changes from what we agreed to back in May," an industry insider told The Hill. "For us, what we're really looking at now is when that agreement can be transmitted to Congress, which we expect to happen in January of 2012. We do not expect any surprises tomorrow or throughout the fall."

The current user fee act expires at the end of September 2012. If it's not reauthorized by then, the FDA will have to lay off some 2,000 regulators, bringing the drug approval process to a halt.

Industry experts say Congress is expected to quickly approve the agreement without making drastic changes to the underlying agreement between the FDA, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO). Democrats led by Rep. John Dingell (D-Mich.) are expected to push their legislation to boost foreign and domestic facilities, the insider said, while conservatives might grumble about the expansion of the federal workforce.

"There is a feeling among some members that less government is always better, and if you cut regulations, that's always a good thing," the insider said. "That's a challenge for us because the FDA is not the EPA; for us, it's vital that we have a very strong FDA with good regulations because that enables us to produce products that save people's lives."

The anticipated ease of the reauthorization is in contrast to the last PDUFA reauthorization, in 2007, when the FDA was under heavy criticism for failing to effectively monitor dangerous drugs such as Vioxx after their approval. This time around, it's the separate effort to reauthorize user fees for medical device-makers, which also expire next year, that's expected to generate controversy as the FDA struggles to overhaul its approval process for low-risk devices.

"I think that'll be where the excitement is because there will be some legislative provisions that will be tacked on to the (Medical Device User Fee and Modernization Act) bill," said Ipsita Smolinski, senior health policy analyst for Capitol Street.