With an eye toward streamlining reviews of increasingly complex medical products and enhancing collaboration between the FDA centers, two leading lawmakers have offered a bill that proposes the establishment of "intercenter institutes" within the agency for major disease areas.

"Good things happen with better communication and collaboration," according to Reps. Fred Upton, R-Mich., and Frank Pallone, D-N.J., the chair and ranking member of the House Energy and Commerce Committee (E&C) in introducing the FDA Cross-Center Collaboration Act of 2016, H.R. 5414. Unveiled Wednesday, the bill, which the sponsors say will help modernize the agency, has been referred to E&C.

The legislation is the same as section 4 of the FDA and NIH Workforce Authorities Modernization Act, S. 2700, introduced by Sens. Lamar Alexander, R-Tenn., and Patty Murray, D-Wash., the chair and ranking member of the Senate Health, Education, Labor, and Pensions Committee, in March. That bill aims to help the FDA and National Institutes of Health attract staff to research and review medical products.

S. 2700 was part of a package of 19 bills that advanced through the HELP Committee between February and April, intended to serve as a companion to the House's 21st Century Cures Act.

Upton and Pallone touted the bipartisan nature of the "commonsense bill," which aims to encourage centers to collaborate to hasten access to medical products. They added that it was an extension of the unity seen in the 21st Century Cures process.

As proposed, the legislation would authorize the HHS secretary to establish intercenter institutes, which would develop processes for coordinating of activities between CDRH, CDER, and CBER. There has been a big push for such an approach for medical product evaluation. In February, the advocacy group Friends of Cancer Research held a Senate briefing on cross-center coordination at the FDA, presenting a plan for an Oncology Center of Excellence. The group also proposed three to four pilot areas, with the first focusing on oncology. It suggested other pilots in the areas of neurodegenerative, cardiovascular and infectious disease.

Also that month, the FDA announced its budget request for fiscal 2017 that included $75 million in mandatory funding to support the National Cancer Moonshot Initiative.

To support the increasing number of cancer diagnostics and therapeutics, the agency proposed a virtual Oncology Center of Excellence to bring together the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices to help. As part of that goal, it would work to expedite the development of combination products and companion diagnostics.

In addition to the goal of streamlining medical product reviews through the intercenter institutes, the bill would encourage the work of established scientific programs within the centers to bring their expertise to the respective institutes. Personnel would be recruited and trained for the institutes, as well as provided opportunities for continued education.

COLLABORATION WITH OUTSIDE STAKEHOLDERS

Enhanced collaboration with outside stakeholders, including patients, sponsors and the biomedical community also is a focus of the bill. Further, it would encourage relationships between the FDA and other agencies within HHS. The secretary also would have the power to shutter an institute if it is no longer benefiting public health. However, the secretary would have to give prior public notice of the institute's termination, in addition to a rationale.

Before an institute could be established, the secretary must seek stakeholder feedback. In addition, the secretary also would be required to create at least one institute by one year after the bill's enactment.

Many stakeholder groups are aware of the bill and are reviewing its proposals. "While we are still reviewing this legislation, we appreciate attention to the need for modernizing the U.S. Food and Drug Administration for it to continue fulfilling its central mission of protecting public health by fostering timely patient access to safe and effective new medicines," Andrew Powaleny, a PhRMA spokesperson, said.

A spokesman for AdvaMed said the organization is still reviewing the proposal and has no additional comments at this time.

LOOKING FOR A DISEASE ATTACK STRATEGY REBOOT

"I think the commissioner is concerned, and probably rightly so, that the different technology areas have become over the years very siloed at FDA," Bradley Merrill Thompson of the law firm Epstein Becker & Green, P.C., told Medical Device Daily.

"Indeed, I do think that science and technology are converging to the point where new strategies for attacking disease will not be neatly divisible into drugs, devices and biologics," added Thompson, who also serves as general counsel to the Combination Products Coalition. When viewed through this lens, he sees the proposal as "very forward thinking;" however, he also is curious about how the initiative would reduce review times in the near term. Further, if the system is not put in place properly, if could cause confusion at the FDA as staff "try to figure out how to work together."

Everything depends on communication, he said, and perhaps that is the whole point of the bill. "In other words, this isn't so much a linear exercise of engineering for a shorter approval pathway, but simply a way organizationally to encourage greater communication and cooperation."

However, not everyone is convinced that the bill will necessarily do much to improve the status quo. "This is a well-meaning piece of legislation, but it doesn't recognize that all of the centers at FDA already work together on many different product reviews," Peter Pitts, president of the Center for Medicine in the Public Interest and former FDA associate commissioners, told Medical Device Daily. "What needs to be addressed is how best to streamline the issue of combination products — an issue noticeably absent from this draft legislation."

Diana Zuckerman, president of the National Center for Health Research, added that the bill as proposed fails to specifically mention money, and this proposal needs sufficient funding for implementation.