Mark McClellan, who served as FDA Commissioner under former President George W. Bush, applauded the funding boost in 21st Century Cures, but cautioned that it would be difficult to estimate how much funding is needed to implement the reforms.
“It’s not just money going to the FDA, it’s money going to fund better scientific development, and we are just in the process of figuring out how much that’s going to cost,” said McClellan, who now works for the Brookings Institute, in an interview. “My own view is that while it’s hard to pin down an exact number, we’re at a point where more investment in the development of science and the FDA is going to have a significant payoff in terms of better outcomes.”
As scientific research gets more complicated, McClellan said, collaboration is imperative.
“The law envisions new ways for developing better science,” McClellan said. “That will take better collaboration with researchers, experts, patient groups and people from industry. It’s really about providing more funding for the gaps in science that are hindering the development of new cures.”
Government funding for the FDA increased from $2.36 billion in fiscal year 2010 to $2.59 billion in fiscal year 2015. In addition to federal funds, the FDA received almost $2 billion dollars in in user fees from the health industry – levied to help fund the approval process – this fiscal year.
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said inadequate funding might force the FDA to cut back on its other responsibilities. She referenced the Food and Drug Administration Amendments Act of 2007, which did not include a funding boost.
“For many years after, we were not on time with our review work, and that was because we were implementing the provisions required under the amendments act,” Woodcock said at an April hearing of the House Energy and Commerce subcommittee on health. The hearing occurred before the bill was amended to include the $550 million in additional funding for FDA; prior to that, the draft legislation didn’t address additional funding for the agency.
Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, raised concerns at the same hearing about a provision in 21st Century Cures that would allow third parties – instead of the FDA – to assess the quality of medical devices.
Under the provision, if a medical-device manufacturer were to modify an existing high-risk medical device, it could hire an FDA-approved outside party to assess its safety and efficacy, bypassing user fees.
Diana Zuckerman, president of National Center for Health Research, said this provision creates a conflict of interest because device makers could choose which third party to assess their product.
“Here you have what we think is a very dangerous and expensive precedent,” she said. “It costs the FDA a lot of money because they have to monitor this program, and they’d lose the user fees. It would be a big loss of income.”
But Rep. John Shimkus (R-Ill.), a member of the House Energy and Commerce Committee, said in a document that the proposal is meant to take the burden off the FDA by leaving assessments to outside parties.
McClellan said he believes it is possible to save money by working with third parties, but added that providing oversight requires resources as well.
“It could be a less costly way to do it, but it does require some investment and effective oversight to make sure that these certification systems are working effectively,” he said, noting that if it were successful it would allow FDA staff “to do higher priority, less routine activities.”
The House Energy and Commerce Committee approved the legislation in a rare unanimous vote last week. Chairman Fred Upton (R-Mich.), who is leading the effort, said he hopes the House will pass the legislation by the end of June.