First Califf Testimony on Hill Places Priority on Staff Development
As most modern FDA commissioners before him did (but more gradually), Robert Califf has swiftly embraced support and defense of the agency workforce below him as Job One. His time as one of them for the past year before his Senate confirmation last week no doubt gave him a major advantage that his predecessors could not have had in rapidly assuming genuine admiration for the quality of FDA people, sufficient for him to tell his first Capitol Hill inquisitors as commissioner that his first priority is to strengthen and better support the agency’s talented and dedicated workforce. “The second,” Califf told a Senate Agricultural Appropriations subcommittee hearing on the agency’s FY 2017 budget 3/2, “is shoring up the science base which includes a heavy emphasis on quantitative analytics... At the core of that is a quality system built on high-level analytics so that we deploy FDA forces in the most efficient and effective manner.” On the drugs and devices side, he identified priorities including Precision Medicine, drug compounding issues, and antimicrobial resistance.
Subcommittee chair Jerry Moran (R-KS) began the questioning with a complaint about FDA’s previous and slow responsive rate to subcommittee questions, and he asked for assurance that members will get full, complete and timely responses to inquiries. Califf said he has a reputation for outspokenness, adding that “FDA can do a better job of explaining what it is doing and communicating... We are going to step up our communications and I can promise you that we will do that.”
Ranking member Jeff Merkley (D-OR) questioned why FDA does not always use its advisory committee when reviewing opioids, especially when considering the country’s worsening addiction epidemic. “Let me be clear, there is no effort by FDA to trash the advisory panel system,” Califf said. We have a new eight-point plan that was just published in the New England Journal of Medicine, with everything from having advisory panels on almost everything to reframing the whole issue. The question is how do you consider a situation where half of the opioids prescribed are actually diverted to someone for whom the prescription was not written... This is major point of emphasis and we are changing tactics on this.” He said the agency will recommend mandatory physician training on how to deal with patient pain and also on the opioid part for pain.
On biosimilars, Moran asked when FDA will finalize all related draft biosimilar guidances. Califf said: “We are very close... so we are going to get these out as soon as we can.” There are 59 compounds in the pipeline now, “and if we don’t get these out soon it will be difficult for people to navigate and know what they need to do.”
Regarding the agency’s information technology plan, Moran urged Califf to take an active role in meeting recommendations in a recent GAO report. Califf said a new chief information officer has recently joined the agency and “we are working with the GAO to close the gaps... I can assure you that in a science-based organization, if you don’t have good knowledge management and infrastructure then you have a real deficit that is going to hurt us, and I am confident we are going to comply.”