Robert Califf was narrowly approved in the U.S. Senate and will return to the FDA as its next commissioner. With this in mind, we found it interesting that in correspondence with two Republican senators, Califf outlined some potential areas where he will focus his efforts. For example, before his nomination was advanced in the Senate, Califf committed to promoting the use of real-world evidence (RWE) and cited the need for better postmarket evidence generation.
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As reported in Regulatory Focus, Califf responded to Roger Marshall (R-KS) and Mike Braun (R-IN), two lawmakers on the Senate Health, Education, Labor, and Pensions (HELP) committee. Regulatory Focus obtained a copy of the questions asked by the senators and Califf’s responses.
“During my last tenure as Commissioner, I helped lead the agency forward toward more widely using real-world evidence in its regulatory decision-making processes. I can assure you that, if confirmed, I will continue this trend, including evaluating all evidence, including RWE, for products that have received EUAs as they work toward full clearance or approval,” Califf told Marshall.
Califf said that part of his agenda will be to develop additional systems and policies for RWE and real-world data (RWD) and that FDA should “continue considering RWD/RWE that is fit-for-purpose.” Califf also committed to working with FDA and the global community to “optimize the quality and reliability” of digital health records in response to a question from Marshall on using RWE from other countries to make faster decisions about products during the pandemic, without compromising FDA’s standards.
In response to Braun, Califf did not answer questions on electronic prescribing information and whether he would “reign in CDRH” in its negotiations with the medical device industry on the next iteration of the Medical Device User Fee Amendments program. Califf told Braun he is not privy to the MDUFA negotiations but committed to working with the HELP committee on reauthorization “to assure the agency is resourced.” Califf also said he would “take a closer look” at FDA’s biocompatibility testing requirements.
Califf also championed digital health technologies and said he is “highly supportive of the efforts of FDA’s Digital Health Center of Excellence and see[s] it as an important way to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation, including for software-based medical devices.” On opioids, Califf committed to “reviewing all aspects of FDA’s role in combating the addiction and overdose crisis” during his first year back at FDA, acknowledging that not enough has been done to stem the epidemic.