To deal with FDA's staffing and expertise problems, new Commissioner Robert Califf wants to access sources outside the agency's walls, as well as build bridges between the siloes inside them.

Califf appears interested in deepening FDA's relationship with outside experts, rather than hiring them, as he looks to increase the agency's stockpile of talent.

In an interview with "The Pink Sheet," the new FDA leader said the agency is working at capacity and will need to hire more people to handle any additional mandates.

But he also recognized that even with a successful hiring surge, the agency cannot expect to house all the available expertise it will need.

"There is no organization in today’s society that can contain all the knowledge that’s needed inside of its own organization," Califf said. "The world has gotten complicated, for the most part, in good ways. And so we also need to be able to tap expertise on the outside in ways that don’t compromise our independence."

Enhancing the FDA workforce is among the priorities Califf named upon taking the position in late February ([A#14160224001]).

Robert Califf

Source: FDA

Tapping outside experts is not all that unusual for FDA in certain settings. Its advisory committee system allowing physicians, researchers and others to help the agency make decisions about medical products is well established.

Review teams also can ask outside consultants to look at portions of a product application, if needed.

And in recent years the agency has expanded its outreach to patients and advocates for input on existing treatments and unmet needs Also see "Patient-Focused Drug Development At 10: Where Does It Go From Here?" - Pink Sheet, 20 October, 2014..

But Califf seems to believe that FDA may need a deeper relationship with some outside experts, potentially for scientific and policy issues.

"I think the main safe harbor for us is the relationships with other federal agencies, like the NIH, where we have a really exciting set of projects that we’re working on together through the Joint Leadership Council," Califf said.

"And then with universities, where programs like the CERSIs [Centers for Excellence in Regulatory Science and Innovation], where this funding of universities could basically work with us in cooperative agreements where we can tap into their knowledge and expertise, and they can learn about what in the past has been a foreign territory for most universities … the regulatory space."

Califf's predecessor, Margaret Hamburg, set up a number of CERSIs to further regulatory science, including improving and modernizing product reviews through better science and training Also see "Good Neighbors Make Good Regulatory Science Centers, FDA Decides" - Pink Sheet, 28 November, 2011..

Whether the agency would be willing to set up official consulting relationships with non-federal agencies is unclear. Califf is concerned about changing the agency's relationship with industry.

"I think those are the main two avenues that we have available right now," he said. "But we’re going to have to think more about it. There’s a lot of interesting back-and-forth right now, for example, between the administration and Silicon Valley, where there’s a lot of talent and expertise. But we have to be especially careful with regulated industries in how we interact."

Engaging internet and technology expertise may prove advantageous to the agency, especially as concepts like "big data" are increasingly employed by pharma companies and FDA.

FDA met with internet search giant Google in 2015 to discuss a potential collaboration for adverse event tracking Also see "Can Google Enhance Drug Safety Surveillance?" - Pink Sheet, 20 July, 2015..

Agency officials regularly conduct public workshops and conferences on specific topics that include industry experts. But it is unlikely FDA would or could work closely with a drug sponsor outside of a regulatory context. Conflicts likely would emerge almost as soon as FDA set such a meeting.

The agency holds tightly to its conflict of interest standards and stakeholders pushed for legislative changes in 2012 after complaints that it excluded too many candidates for seats on its advisory committees Also see "FDA Conflict Of Interest Screening Could Get Streamlined As Patient Involvement Increases" - Pink Sheet, 26 November, 2012..

Mission Critical To Hiring

When it comes to enhancing FDA's internal talent, Califf, like others senior officials, believes he can attract candidates with the agency's mission.

"The mission will get you a long way, as shown by the people currently working here," he said.

The agency also needs to make improvements to its hiring process, he said.

Califf also said over the past year FDA has been "understanding," streamlining and automating the system.

"We feel like if we can make a good job offer and act quickly, we’ll attract a lot of people who just love the mission and have a great chance to see the world of science, which happens at the FDA," he said.

FDA also may have to find a new commissioner in early 2017 when the new president is inaugurated. But Califf does not expect to have to fight to keep the job (see sidebar).

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Wrestling job candidates from the private sector and its higher salaries has been one of FDA's more daunting recruiting problems, in addition to the slow federal hiring process.

Center for Drug Evaluation and Research Director Janet Woodcock has said she needs to hire neurologists, but is unable to offer pay that is close to that available outside the government Also see "Show Me The Money: FDA Recruitment Efforts Challenged By Government Salaries" - Pink Sheet, 12 January, 2015..

FDA has run into similar problems filling senior leadership positions ([A#00140324010]). One solution floated has been to recruit more candidates from an academic setting Also see "FDA Talent Hunt: Is Recruiting From Academia Better Than Industry?" - Pink Sheet, 30 November, 2015..

The agency was successful filling openings when the generic drug user fee program launched. It added more than 1,000 new staffers over several years to support new GDUFA-related responsibilities ([A#14150120003]).

'Professional Homes' To Link Centers

Califf also wants to create what he's calling "professional homes" at the agency. The idea is to "give people an identity, in addition to their FDA identity, and make it a more attractive place to work."

While the biologists, chemists, lawyers, statisticians and others at FDA work on different issues within each center, Califf wants to bridge the gap between each of those positions to "create fluency across the structures that have existed for a long time."

"If you’re a biostatistician in CDER, you’re focused on issues related to drugs. And if you’re in CFSAN and you’re focused on issues related to food. But you also have a professional identity as a biostatistician," Califf said.

"We want to make it easy for people working in different areas because the methods tend to be the same," he added. "And we want to be able to translate effective methods and communicate them across the organization."

"I’m very familiar with the cultural and structural issues that hold back communication … What I’m seeking is to make progress towards a future FDA that’s going to have to be very adaptive to a very different outside environment."
– FDA Commissioner Robert Califf

The idea shares the goal of the Friends of Cancer Research proposal to reorganize FDA along disease-focused areas. Both want to break down barriers between centers to ensure subject-matter experts are working together.

FOCR's virtual centers of excellence proposal has been included in VP Joe Biden's Cancer Moonshot initiative, but some stakeholders, including FDA, are concerned about making another radical change to agency structure.

Several have been done in recent years and another is ongoing Also see "Don't Rush To Reorganize FDA, McClellan Says" - Pink Sheet, 29 February, 2016..

Indeed, Califf also is not the first person with a plan to break down siloes and improve the workflow at FDA or any other large organization. He admitted that he is not unique, but said he has been the person in academia "who was cutting across all the entities."

"I’m very familiar with the cultural and structural issues that hold back the communication that you want," Califf said. "I’m also very familiar with the problems that can occur if you take it too far and destroy the good things about the structures that exist."

Califf said bridging siloes is not a problem "that you solve." He said the necessary changes will help FDA more easily respond to scientific and industry changes.

"There’s a dynamic tension that always will be there," Califf said. "And what I’m seeking is to make progress towards a future FDA that’s going to have to be very adaptive to a very different outside environment."

Combination Product Changes Coming Soon

Among the areas where bridges need building at FDA is its combination products review.

Sponsors have been demanding changes to speed up the process for years. Typically FDA's drug and device centers do not share the same timelines for the different applications associated with the product, often leaving one center waiting for another.

Califf said he does not think that the existing combination product review process is "bad" and that applications tend to move through the system "at a pretty rapid clip."

But he said there is room for improvement and an "internal process" is ongoing that could make a parallel review of the drug and device aspects of a combination easier.

"It’s creating an approach to policy that really brings the centers together, so that the basis for the reviews is more policy-based rather than one at a time," Califf said. "I think it’s been very well received internally. And we’re also spiffing up our information technologies, so that we can move things more efficiently when it comes to consults between the centers, which is the way it has to work."

More information on the new policy should be available over the next month or two, he said.

Califf said during his confirmation hearing that he favored creating a new approval pathway for combination products.

The House-passed 21^st Century Cures Act, which is awaiting completion of a companion bill in the Senate, requires FDA to issue final guidance on the responsibilities of each center during combination product reviews Also see "Califf Supports Combo Products Pathway At Confirmation Hearing" - Pink Sheet, 17 November, 2015..

Agency officials also have hinted that joint drug and device negotiations may be possible to create a new pathway and performance goals ([A#00150629007]).

Califf Lowering FDA Drawbridge To Work With External Expertise

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