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Inside Health Policy – Regulatory Science Centers Push Forward Despite Funding Uncertainty

Inside Health Policy – Regulatory Science Centers Push Forward Despite Funding Uncertainty


Leaders of two academic centers tapped last year to pilot FDA’s Centers of Excellence in Regulatory Science and Innovation program said they are concerned about possible loss of funding

 due to sequestration or a constrained fiscal environment but are moving ahead while also remaining hopeful that some of the work would continue if federal funding is reduced. FDA — which planned to fund the collaborative centers at $1 million a year for three years — has already transferred money within the agency to bolster the programs and the agency’s science board was recently tasked with providing FDA input on the collaborations.

FDA officials have said regulatory science could take a hit if $319 million in cuts mandated by sequestration go into effect although the agency will look to leverage its resources through partnerships to continue its work.

William Bentley, co-director of the University of Maryland CERSI, said the constrained fiscal environment is a “big concern.” “If the FDA money were to disappear, it would be a major problem,” he said, adding that the scale of the program would have to be “dramatically” cut back.

The center is currently involved in three collaborative research projects, along with an innovation awards program, staff training and scientific exchange, and outreach and academic programs. Bentley said some efforts — like staff training and scientific exchange programs — would likely continue with a reduced budget but research projects may be scaled back.

Bentley said he has not discussed the impact of sequestration on the center with FDA, but he said regulatory science and the centers are of high importance for the agency, with money for the projects coming from the office of the commissioner. “We are definitely doing everything we need to do to make sure it is a success,” Bentley said, although he acknowledged that “if there is a big cut at the FDA, their core mission is going to come first.”

FDA started the centers in October 2011 in an effort to bolster the agency’s regulatory science program, which has been a major push of FDA Commissioner Margaret Hamburg. The two local centers at Maryland and Georgetown University — established under collaborative agreements with FDA and the universities — were intended to serve as pilots for expanding the program as funding allowed.

FDA officials have warned that non-core initiatives like regulatory science programs could take a hit if sequestration is triggered, with the agency recently asking its science advisors to update a regulatory science report to help the agency allocate its resources, including evaluating its regulatory science collaborations (see FDA Week, Oct. 5).

Both centers said the FDA funding is contingent on periodic reviews, and there is no guarantee funding will be continued year to year. Bentley said FDA had to cut funding for the CERSI for the second year by 20 percent but was able to add back roughly the same amount by taking money from the Office of Minority Health. As a result, the center will initiate projects focusing on minority health and equity issues.

Further, Bentley said every federal agency warns people they support that funding could be cut in the future. Ira Shoulson, director of the program in regulatory science and medicine at Georgetown University, said the uncertainty of government funding in general — whether from FDA, the National Institutes of Health or other agencies — is an ongoing issue.

“The issue of how to sustain funding and the prospects of cuts are always there,” he said. “I don’t see this as any different.”

“I’ve got a thick skin,” he added. “Is the sky falling? No. Are we realistic that things may change? Yes.”

Shoulson said while the center has thought about the possibility of a reduction in funding, they are “planning for success.” “Obviously there would be a contingency,” he said. “I just find it easier to plan for success and as necessary adapt to the realities of the funding environment.”

Georgetown had a program in regulatory science and medicine before it created the CERSI, Shoulson said, adding the university is committed to doing regulatory science and would likely continue the program in the absence of FDA funding, but “certainly there are issues of scalability and expansion that would come into play.”

Through the collaboration with FDA, Georgetown has started research projects in bioinformatics and data sharing, including projects focusing on predicting adverse events and biomedical pathways for vaccines, using pharmacogenomics in cancer, and analyzing models and attitudes regarding voluntary clinical data sharing. The university has also started educational and training programs for FDA staff and others, including a master’s program in regulatory science. Georgetown also plans to start a project focusing on health and scientific literacy among minority populations.

Researchers at the University of Maryland are studying membrane transporters in drug development, evaluating new device-focused technologies including laser-based therapeutic and tissue engineering systems, and examining patient-prescriber agreements for prescription opioid drugs. The university also recently started an industrial consortium at the center with nine biomedical companies that will allow academics, FDA and industry to work together on regulatory science issues.

Bentley said the CERSI program has allowed Maryland and FDA to formalize and ramp up their interactions, which they have had for many years, adding that the program allows FDA to stay on top of the newest technologies. “They want to leverage as much as they can, and that is really a great idea,” Bentley said.