The US Food and Drug Administration is becoming over-reliant on user fees which it receives from pharmaceutical manufacturers, Congress was told by both consumerists and industry representatives this week.
The Biotechnology Industry Association believes this over-reliance is creating an “unseemly misperception” that the agency is beholden to the industry it regulates and, in the long term, this is not in the best interests of patients, biopharmaceutical innovators or the FDA, said Kay Holcombe, senior policy advisor for Genzyme, who was speaking on behalf of BIO at a hearing held by the House Committee on Energy and Commerce’s Health subcommittee to discuss the reauthorisation of the Prescription Drug User Fee Act (PDUFA IV).
In 2005, user fees funded more than half of the cost of the FDA’s core human drug programme compared to 7% at its start and, unless appropriations increase substantially more than they have over the last 10 years, user fees could account for more than two-thirds of the cost of the programme by the end of PDUFA IV’s five-year term, said Ms Holcombe.
The fee rises proposed under PDUFA IV are necessary, but BIO believes the FDA also needs increased appropriations to continue its mission of protecting patients “as it faces a revolutionary new era of scientific innovation and advancement,” she added.
Major legislative issue
Alan Goldhammer, deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), described PDUFA’s reauthorisation as one of the more important legislative issues facing Congress this year. “Although the industry-funded part of the drug review process will increase during the PDUFA-IV years, patients will be well served by a more predictable drug review process and assurance that the robust drug safety office within the Agency will be enhanced and modernised,” he said.
However, Consumers Union senior health policy analyst William Vaughn told the hearing that “if there were ever a public function that should be funded out of the Treasury, this is it.”
“The user fee system - with its incredibly detailed requirements from the pharmaceutical industry for the FDA to respond to requests from industry, to schedule meetings within X weeks of a request, etc, etc. etc - is terribly damaging to the image, morale and public service culture of the FDA,” he said.
Nor is the current system good government, he added, and asked the panel: “Imagine what the public would say if Microsoft funded more than half the budget of the Department of Justice’s Anti-Trust Division or Boeing paid more than half the cost of the National Transportation Safety Board? The same perception problem exists with PhRMA funding of the FDA.”
However, Mr Vaughn acknowledged that, if the FDA is to be able to continue approving new drugs, user fees will almost certainly be needed for at least another year, but he called for the same emphasis on speed of approvals to be given to a high-speed, high-quality post-approval safety system.
Specific, additional safety initiatives should ideally be funded by increased appropriations but, if necessary, by further rises in user fees, he said, and also called for consumers to see some “tough deliverables, just like PhRMA gets.” While user fees that go to pre-approvals and speeding approval are used to achieve very detailed and date-specific deliverables, the entire tone and structure of the FDA’s PDUFA safety provisions are currently “very fuzzy, very academic and very bland,” he said.
All witnesses stressed to the legislators the importance of a speedy reauthorisation before PDUFA III expires on September 30. Said Theresa Mullin, assistant FDA Commissioner for Planning: “Any delay in the reauthorisation of this program could trigger erosion in our workforce, particularly among senior reviewers whose skills are in very high demand. The repercussions of such a loss would be with us for years to come,” she warned.