A cancer patient advocate worries that President Donald Trump’s hiring freeze could put a crimp in FDA’s newly launched Oncology Center of Excellence (OCE), an initiative aimed at speeding patient access to cancer treatments and which is viewed as a possible model for creation of other disease-focused centers in the future.

FDA formally launched OCE Thursday (Jan. 19) as part of the Cancer Moonshot Initiative. While the new center is expected to streamline approvals of cancer products, it will require FDA to hire on more staff and shift agency personnel to work in the center. The president’s recently signed federal hiring freeze says no new positions may be filled or created as of Jan. 20, 2017, unless they fall under certain exemptions.

Ellen Sigal, founder and chair of Friends of Cancer Research, said she’s worried the hiring freeze will hamper the OCE’s development, as the center will require a large amount of new hires in its first year and require some shifts in personnel at the agency. While she is not sure whether the hiring freeze stops those currently employed with the agency from being moved to different departments and centers, the freeze does affect new hires.

“I am worried about it. At a minimum, it’s going to slow things down, which means patients will be disadvantaged. If [the freeze] continues, it will be draconian to public health and cancer patients. A three-month freeze isn’t going to kill anyone but it certainly slows down [the center implementation] process,” Sigal told Inside Health Policy.

While she said hiring mechanisms were improved under 21st Century Cures, she emphasized it’s still not easy to hire at FDA, and a hiring freeze will only exacerbate the issue.

“The intent of the legislation was to make [hiring] easier and [for FDA to] pay more competitive wages. But now that’s a huge problem because implementation is going to be slowed down considerably,” Sigal said.

Clinical review process across its drug, biologics and device centers focused on a specific disease area. It’s intended to serve as a model for other potential centers going forward, including cardiology, neurology and infectious diseases, Friends of Cancer Research said. Sigal described it as the “north star” of innovation.

“This center is a lab for innovation. The expectation is it will help with all diseases. It will help get things out that will impact patients. The Trump administration plays a role — they care about innovation and public health,” Sigal told IHP, referring to conversations Trump had earlier this week with the pharmaceutical industry where he discussed getting therapies approved faster to make them available to terminal patients and promoting innovation within the industry.

Sigal noted that in addition to ensuring OCE is fully staffed, it’s essential to appoint an FDA commissioner who knows and respects the history of FDA and its accomplishments.

“The commissioner should be an MD — someone who has actually treated patients and has medical training. Also, someone who understands science. One can’t go into the agency and blow it up…You have to respect the culture of what’s happening,” Sigal told IHP. “A leader has to be someone who understands the mission of public health. This isn’t a start-up company. These are people who are making decisions on life-and-death and treatments. We all want innovation and want to have things faster, but we want things that work.”

She added that public health, public safety and innovation are all important. “We don’t want things on the market that aren’t safe. A leader should be someone who understands the culture and who respects what’s been done and grow it … and be advocate for patients and public health.”

Sigal also emphasized the problem with the hiring freeze extends beyond just the center. As FDA focuses on public health, Sigal hopes the agency will fall under an exemption listed in the president’s hiring freeze memo that says: “The head of any agency may exempt any position that it deems necessary to … Meet public safety responsibilities (including essential activities to the extent that they protect life and property).”

“This is public health … Patients are impacted by this. This goes beyond the cancer center. It’s national security,” Sigal said, adding that FDA addresses issues with drug manufacturing, as well as monitors and manages health scares and safety problems and protects the nation’s food supply. “These are essential jobs. It’s not any different than DOD or the VA. The agency is a public health agency. Obviously I’m very concerned, and it will impact the implementation of the center.”

In November 2016, former FDA commissioner Robert Califf spoke at Friends of Cancer Research and Prevision Policy’s Biopharma Congress event about the impact the 2016 election would have on the pharmaceutical industry. He discussed how important it is for the “next administration” to recognize the importance of FDA to more with patients and to be disease-focused.

“We are going through some internal exercises now to take our leaders and have them envision the future, you know to leave for the next administration to think about because I think things are changing so fast now that we, I think we owe it to people to think very carefully about the future,” Califf said at the event. “Historically…FDA has been remarkably siloed. Academia and industry, you know, 15 to 20 years ago moved mostly to a matrix organization and FDA for a whole variety of reasons has been drugs, devices, biologics, food and a few things folded in like cosmetics and such, and then you know we added tobacco, which is another silo. But what you hear loud and clear from patients is they’d like to have a way to be in contact with the FDA, to interact with the FDA — and you also hear this from clinicians and practitioners — in a way that’s not by product type but more by whats relevant to their disease.”

Sigal said OCE and its director Richard Pazdur will help break down those silos and help drive innovation.

“This is a model to look at as to how to expedite innovation and therapies. We have to work with patients and academics and developers. This will accelerate that. I know Dr. Pazdur is not just going to break down silos within agency, but he is going to work with groups and promote innovation.”

Hiring and funding are essential to the development of OCE and for future FDA disease-focused efforts, Sigal said.

“Hiring and funding are clearly important. The idea of leadership and innovation and this being a model for other disease areas is important. There will be a lot of experimentation there, and it’s important to have the involvement of the entire community…I’m incredibly excited. I think the possibility of what this can accomplish will be a model for industry and patients and it’s very important. This is not a minor structural change. It’s a different way of doing business. The outcomes can be dramatic and exciting. We’re very anxious, but we will have metrics. We will see what worked and what didn’t work.”

https://insidehealthpolicy.com/fda-week/cancer-research-group-fears-hir…