The Califf Regime and the Critical Path to Confirmation

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  • 09/17/2015

Some good quotes from A Califf Regime: The Disruptor FDA, Industry Need, by the very savvy Donna Young of Scrip Intelligence --

The complete story (subscription only, sorry) can be found here.

If Robert Califf is confirmed as the next commissioner of the FDA – which most in the biopharmaceutical community are anticipating is all but assured – he'll be taking over an agency that's in the midst of some of the most complicated challenges it's ever faced, the resolutions of which have broad implications for drug and device makers.

The FDA is dealing with an inability to attract and retain the best and the brightest scientists, noted Ellen Sigal, chair of the nonprofit advocacy group Friends of Cancer Research (FOCR). "The salaries are terrible, hiring practices are convoluted and divestiture is complex," she told Scrip.

… Greg Daniel, managing director for evidence development and innovation at the Brookings Institution's Center for Health Policy and a fellow in economic studies at the Washington think tank, said another problem confronting the FDA is its need for consistent resources and funding to maintain and build on the advances the agency has made in developing new tools and refocusing on patients through new expedited development and review programs.

… Peter Pitts, president of the Center for Medicine in the Public Interest, a Washington think tank, and a former FDA associate commissioner during the George W. Bush administration, insisted Califf is the right leader and "precisely the right guy" to handle the knotty challenges ahead for the US regulatory agency – declaring the former Duke University professor's nomination was "the most important health care act the president has undertaken," even more so than getting the Affordable Care Act enacted.

President Obama’s nomination of Califf, announced on Sept. 15, "really is the biggest thing he's done to advance the public health," Pitts told Scrip. "I really believe that."

If confirmed as commissioner, Pitts said he thinks Califf, who he called an "action-oriented guy," will have an "immediate impact for many issues that need immediate attention" at the FDA – most specifically, precision medicine.

The fact that the past few times a new commissioner was being sought by Democratic and Republican presidents and Califf's name kept coming up as a potential contender demonstrates "he's highly qualified" and capable of doing the job, Pitts said, adding that it also shows that "occasionally, there is bipartisan sanity when it comes to health care issues."

What's most important, Pitts said, is that Califf is viewed as a well-respected scientist – both by regulators and industry alike.

Before joining the FDA this past February as deputy commissioner for medical products and tobacco, Califf had worked closely with the agency on several matters, including serving on its Cardiovascular and Renal Drugs Advisory Committee, "so his learning curve is not steep," Pitts said.

He said Califf also is well respected among regulators at agencies outside the U.S. – an asset that could aid the FDA and other regulatory bodies in harmonizing their review processes and rules, which could broadly benefit the drug and device industries.

But one of the greatest qualities Califf possesses, Pitts said, is his ability to innovate.

"He can take a theory and make it a practical reality," Pitts said, adding that he anticipates Califf to lead the FDA to be "partners in innovation" with industry through "entrepreneurial regulation."

"What that means is that Rob Califf can put the FDA at the center of the health care innovation ecosystem," he declared.

… "He's well known to be an innovator," Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio, said about Califf. "He's been innovative in the design of clinical trials and has long been an advocate of finding ways to do clinical trials that are better, cheaper, faster. He's been somebody who has been outspoken about the fact that the approach we use for drug development is too costly and in some cases too long." Nissen said the current FDA is suffering from "years of stagnation."

"The FDA has not moved forward on any important initiatives during this period of stagnation," he argued. "And it needs a new look. It needs somebody to really come in and really shake things up."

Califf, Nissen said, is "capable of doing that … We really actually see the world pretty similarly."

Industry Ties

But while Nissen and Pitts showered praise on Califf, Public Citizen's Carome asserted President Obama's candidate to run the FDA was "bad news for patients and public health" because of the former Duke University professor's "long history of extensive financial ties to multiple drug and medical device companies."

But Pitts argued that "in my mind, the commissioner of the FDA should have an extremely up close and personal knowledge of industry to understand what's happening … I think anybody who knows Rob Califf knows he's not swayed by any financial interests," he said.

… Pitts, Nissen and Sigal all advocated for keeping Califf in the commissioner's role long after President Obama leaves office – declaring the FDA chief's job should be a five- or six-year term.

"I've long been an advocate for this not to be a political appointment," Nissen said.

The next critical path is the path to confirmation.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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