Learning To Drive The ‘Chariot’: FDA Deputy Califf’s New Role
This article was originally published in The Tan Sheet
Executive Summary
Renowned clinical trialist and cardiologist will become deputy commissioner for medical products and tobacco, a complicated and challenging position.
Robert Califf will enter a senior FDA position that is nearly four years old, but remains largely undefined as far as its role in the agency management hierarchy.
The deputy commissioner for medical products and tobacco, which Califf will become in late February, is designed to manage the drug, biologic, device and tobacco centers, as well as the Office of Special Medical Programs in the Office of the Commissioner, and coordinate their activities across common issues.
It is a task that is easy to describe, but much more difficult to perform, according to a number of former FDA managers and staff. The programs that Califf will be managing, and the constituencies that he will be serving, have very different interests and priorities that in many instances do not fit together.
“Trying to oversee the product centers is kind of like holding a chariot with 12 angry, huge horses, Clydesdale horses,” Marc Scheineson, a former FDA associate commissioner for legislative affairs and now head of the food and drug law practice at Alston and Bird, said in a Jan. 28 interview. “But those horses are all going in different directions.”
Califf’s job will include looking for “similarities and differences in the medical product arena and helping it fit into the larger picture,” said Rachel Sherman, former director of the FDA Center for Drug Evaluation and Research’s Office of Medical Policy, and now a principal at Greenleaf Health.
In addition, because the position has been vacant for more than 18 months and those that had filled the job did not remain with the agency very long, Califf may find himself largely creating his role at FDA, since the center directors that will be his direct reports are used to dealing directly with Commissioner Margaret Hamburg.
Former FDA Principal Deputy Commissioner Joshua Sharfstein said in an interview that there is “tremendous potential in that position” to coordinate work between centers. But he said the job should not be thought of as someone who will help make every regulatory decision.
“Trying to oversee the product centers is kind of like holding a chariot with 12 angry, huge horses.” – Marc Scheineson, Alston and Bird
“The right way to think of the position is someone who can provide strong scientific leadership to coordinate the effort,” said Sharfstein, who now is associate dean for public health practice and training at the Johns Hopkins Bloomberg School of Public Health.
Stephen Spielberg was the first to have the job, following a reorganization after Sharfstein’s departure from FDA. But Spielberg left after less than two years because of a family medical issue (Also see "Spielberg’s Replacement At FDA Also Will Have Strong Industry Ties" - Pink Sheet, 22 Jan, 2013.).
Associate Commissioner Leona Brenner-Gati took over on an acting basis, but left after less than three months (Also see "FDA’s Potential Black Hole: House Investigates Departure Of Acting Head Of Medical Products Office" - Pink Sheet, 14 May, 2013.).
Califf likely will have to define his relationship to Hamburg in terms of agency management as well, Scheineson said.
“He could be a good outside spokesperson. He could be a good representative at international meetings,” Scheineson said. “But that’s a lot of what the commissioner is supposed to be doing. The question is: How will he and Dr. Hamburg work together?”
Califf, who declined to comment on what his role would look like, also likely will have to sever a number of consulting and other industry relationships that he cultivated while at Duke University (see).
A number of stakeholders view Califf as Hamburg’s eventual successor (Also see "FDA Lands Duke’s Califf As Top Deputy, Potential Next Commissioner" - Pink Sheet, 26 Jan, 2015.).
FDA Efficiency A Potential Focus
FDA said in its hiring announcement that among the “cross-cutting clinical, scientific and regulatory” issues Califf would handle are personalized medicine, orphan drugs, pediatric science and the advisory committee system.
Califf already has FDA advisory committee experience. He has served on the Cardiovascular and Renal Drugs committee as well as the Science Board Subcommittee on Science and Technology.
Sharfstein identified personalized medicine as a potential area for Califf to coordinate because it involves the drug and device centers, who often must both review different aspects of a product before it can be approved.
That issue is expected to grow in prominence in the coming months after President Obama identified it as a priority in his State of the Union address (Also see "‘Precision Medicine’ Gets R&D Funding Push In President’s Speech" - Pink Sheet, 21 Jan, 2015.).
Industry has complained that the review timelines between the centers often do not line up. FDA in some cases has reviewed combination products as one application, rather than requiring separate drug and device filings, in order to speed up the approval process (Also see "CDER-Only Reviews Increase For Combination Products With Stand-Alone Devices, But Issues Remain" - Pink Sheet, 28 Jan, 2013.).
Scheineson said Califf likely will look to find efficiencies between the activities of the various centers.
“I think he’ll quickly find ways in which he can complement and not duplicate what’s going on in the agency and that’s probably more on a higher plane of trying to streamline agency reviews, trying to improve efficiencies and retool the agency with additional scientific expertise,” Scheineson said.
The Center for Drug Evaluation and Research in 2014 once again posted a strong year for novel drug approvals (Also see "New Drugs Show How FDA Incentives Look Beyond Innovation" - Pink Sheet, 19 Jan, 2015.).
But industry always seems interested in further streamlining the drug development process and encouraging innovation.
Among the proposals in the new House 21st Century Cures bill is an adjustment to the tropical disease priority review voucher program allowing FDA to easily expand the list of eligible diseases (see (Also see "Tropical Disease Voucher Program Would See Another Boost In Cures Bill" - Pink Sheet, 2 Feb, 2015.)).
The draft bill would also mandate that FDA accept different kinds and amounts of data for approval (see (Also see "New Rx Approval Standards, Faster Pathways Offered In Cures Legislation" - Pink Sheet, 2 Feb, 2015.)).
Scott Gottlieb, a former FDA deputy commissioner for medical and scientific affairs and now resident fellow at the American Enterprise Institute, said in an email that Califf will be valuable to the Center for Tobacco Products in a chief medical officer capacity to “give it a more focused clinical imperative” as well as put the focus on the public health issues in the tobacco legislation.
Gottlieb also said Califf’s experience as a clinical trialist and cardiologist should allow him to influence drug and device center policies (see (Also see "Califf’s Trial Design Prescription: Less Randomization, More Transparency" - Pink Sheet, 2 Feb, 2015.)).
Focus On Big Picture, Not Details
As a top senior manager at the agency, Califf also likely will be asked to help outline or promote FDA’s stance on various overarching issues.
During his time as deputy commissioner for medical products and tobacco, Spielberg was a frequent speaker at workshops and conferences on a wide range of topics, including drug repurposing, tobacco regulation and personalized medicine.
Spielberg also made a number of trips to foreign countries to speak on behalf of the agency (Also see "Sequester Travel: Halved FDA Budget Limits Opportunities For Scientists, Impacts Senior Officials Too" - Pink Sheet, 16 Sep, 2013.).
Among Spielberg’s early priorities was to focus FDA’s collaboration with the National Institutes of Health (Also see "FDA's Spielberg Wants NIH/FDA Collaborations To Focus On Problem-Solving" - Pink Sheet, 27 Oct, 2011.).
Califf also could be successful encouraging public-private partnerships that involve FDA, according to Nancy Myers, a former FDA staffer and now president of Catalyst Healthcare Consulting.
“I think most stakeholders would see that he’s the kind of person who’s willing to pull all stakeholders together to find a solution,” Myers said in an interview.
But while Califf may be required to deal with details affecting multiple centers, Scheineson and Sherman warned that he likely would be better off staying away from them.
“On the management side, I think if he’s smart he’s going to leave that to the center directors and just try to complement where he can,” Scheineson said.
Sherman also said Califf should not “lose sight of the big picture.”
“Rob has this wonderful capacity to seek common ground, to seek consensus,” she said. “Those are the skills and talents one needs to do … that kind of job with that kind of complexity and that many competing priorities.”
Both former FDA officials also thought Califf will do well to mentor the young staff at the agency and cultivate future leaders.
“He just will be a great person to have around, walking the halls, talking to the troops,” Sherman said.
Recruitment has been a problem for FDA, especially at the management level.
The agency has been slow to fill a number of senior management positions, in part because of quirks in the federal recruitment process (Also see "FDA Searches Small Industry Candidate Pool To Fill Executive Vacancies" - Pink Sheet, 24 Mar, 2014.).
CDER has hundreds of open positions, which have been difficult to fill in part because of salary restrictions (Also see "Show Me The Money: FDA Recruitment Efforts Challenged By Government Salaries" - Pink Sheet, 12 Jan, 2015.).
FDA did exceed its hiring goals for the generic drug user fee program, adding more than 1,000 people for various roles (Also see "FDA’s Generic Drug Staff To Be Reduced When Workload Under Control" - Pink Sheet, 20 Jan, 2015.).