Sharpless Vows to ‘Listen to FDA Experts’
FDA acting commissioner Ned Sharpless told the Food and Drug Law Institute’s annual meeting 5/2 he plans to heed the advice he heard most frequently from former commissioners he consulted before he moved to the agency last month from NIH: “Listen to the FDA experts around you.” Sharpless was especially appreciative of Scott Gottlieb, “who was extraordinarily supportive and helpful during the transition.” Assuring his audience he would listen to FDA’s experts, Sharples broadened that group to include the “great leadership across the agency, as well as the talented workforce that offers such a remarkable range of skills.” He said there are no plans for “extraordinary departures from the FDA’s recent priorities and course of action.”
Sharpless told FDLI that he may be the acting commissioner, “but I won’t be acting as if this is a temporary job. Secretary Azar and the White House made it very clear to me that they have been impressed with the things that FDA has been accomplishing and they don’t want to disrupt this strong progress. There will be no pause at FDA. So we’ll continue to focus on innovation and efficiency, in order to bring more new medical products more quickly to the public, and to ensure that FDA’s processes are as modern, efficient, and risk-based as possible across the agency. We want to continue to encourage the regulatory certainty, flexibility, and transparency that allows industry to innovate and the public and stakeholders to get what they need.”
In the drug arena, Sharpless has high hopes for CDER/CBER expedited program tools — fast track, breakthrough, accelerated approval, and priority review — which continue to help speed drug development and review. “Sponsors took advantage of at least one of these innovative expedited programs in 73% of the novel drug approvals last year by CDER,” he said. “It’s important to reaffirm that as we work to make our process more efficient, we will always maintain our focus on the FDA’s gold standard of safety and efficacy. Safety is a priority before and after approval, and the public depends on our diligence in identifying issues when they occur.”
Sharpless said the agency is also seeing dividends with its Biosimilars Action Plan to accelerate biosimilar competition. Biologics represent the “fastest growing category of U.S. drug spending, accounting for 70% of the growth in drug spending from 2010 to 2015,” he told FDLI. “This plan is beginning to work. Last year, we approved a record number of biosimilar products, meaning patients can receive the treatments they need, while the market benefits from increased competition and ultimately lower costs.”
Another growing area on FDA’s radar is gene therapies, Sharpless said. “We received over 200 gene therapy INDs last year,” he said. “Our goal is to support this work and advance the field while being transparent about our expectations. As a result, we issued numerous guidance documents with more on the way. The second area of CBER where we’re seeing an extraordinary pace of progress is in the development of cellular therapies and, especially, stem cell products. We’re doing everything we can to support this growing industry. But even as we do so, we want to maintain our focus on compliance and enforcement. We won’t tolerate dangerous stem cell clinics who make dubious or unproven claims that their cellular products will treat age-related or other serious or life-threatening conditions.”
With devices, the acting commissioner noted that the agency approved 106 novel devices last year, “surpassing the 40-year record FDA set the year before, and continuing on a steady upward climb.” His FDLI address also touched on in vitro diagnostics: “When it comes to embracing state-of-the art science, the work being done on the in vitro clinical tests may set the standard. We support a legislative solution that presents a consistent approach for all in vitro tests, regardless of whether the test developer is a conventional manufacturer or a clinical laboratory, and we are committed to making this an agency priority.”
And to accentuate FDA’s investigation and enforcement efforts, Sharpless gave a shout out to the Office of Regulatory Affairs (ORA) — “the heartbeat of FDA if you will, in everything we do across the agency. ORA’s vital staff, spread out across the nation and the world, make sure that FDA’s words have meaning, and that its actions have teeth.” He mentioned progress on implementing the Mutual Recognition Agreement with the European Union, which will improve FDA’s global oversight of pharmaceutical manufacturing. “We expect to complete all the remaining [European regulator] assessments in the next several months, on schedule,” he said.