Sept. 2, 2011 – 8:17 p.m.
The pharmaceutical industry continues to push lawmakers to act quickly on approving a deal that would fund the Food and Drug Administration’s drug review process.
But, although lawmakers from both parties have pledged to mark up the legislation — known as the Prescription Drug User Fee Act (PDUFA, PL 110-85) — months before its Sept. 30, 2012, expiration date, not everyone is on board.
The agency is keeping a quick pace anyway, and last week published a draft proposal based on a deal negotiated with industry stakeholders for what would be the fifth program reauthorization.
“It is critical for PDUFA to be reauthorized well in advance of PDUFA IV’s expiration in September 2012 in order to avoid a reduction in force at the FDA,” said Jim Greenwood, president and chief executive officer of the Biotechnology Industry Organization. “Even the threat of a downsizing at the FDA would be devastating to the agency’s public health mission and its ability to review new drugs and biologics.”
Tom Harkin, chairman of the Senate Health, Education, Labor and Pensions Committee, praised the agency’s work on the law’s reauthorization. His committee held its first hearing on the reauthorization in late July and plans to hold more in the coming months.
“I am pleased that the FDA and drugmakers were able to reach an agreement in a timely way and look forward to reviewing it in detail,” said Harkin, D-Iowa.
Harkin and the panel’s ranking Republican, Michael B. Enzi of Wyoming, have agreed they want to mark up the legislation by early next spring. In the House, Republican Joe Pitts of Pennsylvania, the chairman of the Energy and Commerce Subcommittee on Health, has said he wants a measure signed into law by June 30.
But Sen. Richard M. Burr, R-N.C., has said the reauthorization could be “a very slow and laborious process” because of his concerns over how the FDA calculates the time it takes to review a product.
The FDA’s proposal sets performance goals for drug review times, amid industry concerns that the agency’s approval process lags behind those of other countries.
It also would continue the current user fee agreement through fiscal 2017. The drug industry agreed to a 6 percent increase in user fees over the fiscal 2012 amount, FDA Commissioner Margaret Hamburg said, which would give the agency about $712.2 million in fiscal 2013. User fees currently make up about 60 percent of the costs of FDA’s drug review program.
According to the draft proposal, the user fees would be used for several activities, including new ones to reduce medication errors and to determine whether the national electronic system known as Sentinel, designed to mine data and spot potential safety concerns, can be used to find issues that require regulatory action. In addition, under the agreement, the FDA would issue guidance on standards and formats for submitting drug review applications electronically.
Still being worked out is the FDA’s agreement with medical device companies for that program’s user fee reauthorization, which also expires Sept. 30, 2012. Industry officials reportedly are balking at requests from the FDA to raise user fees to about $770 million from 2013 through 2017.
Industry group Pharmaceutical Research and Manufacturers of America praised the PDUFA-V agreement.
“If implemented as published, the PDUFA-V agreement will provide the FDA with much-needed resources and management tools to support patient safety and to promote innovation through increased transparency, predictability and efficiency in FDA’s science-based human drug review program,” said David E. Wheadon, the group’s senior vice president for scientific and regulatory affairs.
Even with the agreement, Greenwood said, Congress should fully fund the FDA at the administration’s requested fiscal 2012 level. The administration requested $2.7 billion for the agency’s regulation of drugs, devices and food — about 5.6 percent more than it received in fiscal 2010. Including user fees and other revenue, the funding level would total nearly $4.4 billion.
Rebecca Adams contributed to this story.