Is the FDA Ready For 21st Century Cures?

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Legislation to expedite the approval of new drugs passed its first hurdle last week, but Food and Drug Administration officials say the funds granted by the overhaul effort aren’t enough.

The bill, also known as 21st Century Cures, will place new pressures on an agency that says it’s responsible for regulating products that account for as much as 25 percent of U.S. consumer spending. Some experts say the FDA must collaborate with other government agencies to share the burden, but a provision in the bill to rope in outside regulators to approve new devices is causing concern.

The legislation would provide the FDA with $550 million over a period of five years to implement the changes – just 5 percent of the $10 billion funding boost 21st Century Cures offers to the National Institutes of Health over the same period. Speaking on background, an FDA official said it would cost more than $882.8 million over the next five years to implement the reforms in 21st Century Cures.

A spokesperson for the House Energy and Commerce Committee said in an email that committee leaders are waiting for the Congressional Budget Office to release its cost estimate of 21st Century Cures before considering adjusting funding levels.

Paul Howard, director of conservative think tank Manhattan Institute’s Center for Medical Progress, questioned whether the FDA actually needs more funding. Instead, he said, the FDA must collaborate more with other agencies and outside groups.

“The way that the science is moving, the FDA is never going to be able to do this all in-house,” Howard said in an interview. “It doesn’t have the funding, but then maybe it doesn’t need to because there are lots of other places out there at patient groups, at NIH . . . and other consortiums that could do this work for the agency and hand these things off to the agency.”

“Here you have what we think is a very dangerous and expensive precedent. 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.” – Diana Zuckerman, president, National Center for Health Research on third-party evaluation of new medical devices

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.