As the US Food and Drug Administration (FDA) transitions between commissioners, continues negotiating industry user fee commitments and prepares for a possible legislative overhaul, a major transformation is in the works for the agency over the next couple of years.
FDA Acting Commissioner Stephen Ostroff told attendees on Tuesday at RAPS' Regulatory Convergence that he's seeing an "unusual confluence" of events, particularly as the House-passed 21st Century Cures legislation makes its way through the Senate, and as user fee negotiations have to be wrapped up by January 2017.
"All I have to say is stay tuned, we're in uncharted territory," Ostroff said.
He also noted a number of new FDA initiatives that are progressing, particularly as FDA's field personnel will be more specialized, the importance of biomarkers in drug development and how FDA is looking to incorporate more patient perspectives into the regulatory process.
"Today, there's so much innovation going on and so many regulatory authorities" that the traditional way the FDA field force works -- with inspectors working across the gamut of drug, biologics, food and medical device facility inspections -- will no longer be feasible. "It's impossible for them to maintain proficiency" across so many disciplines, he said, noting that moving forward each of the district offices will only focus on one area of products.
"Some offices will focus only on drugs, some on biologics, some on food and some on importation," he said, adding that the alignment of changes has been completed and implementation will happen over the next year or two.
As far as the more patient-centric approach FDA is taking, Ostroff noted the recent addition of a patient advisory committee for medical devices but added that meaningful patient engagement "is not without its challenges." More specifically he pointed to the fact that patients have to understand the regulatory framework, how clinical trial design works and that FDA has to juggle a confluence of so many different perspectives.
He also stressed the importance of FDA's push to improve its regulatory science, which is being pushed by a science advisory board at the agency.
"We have to preserve FDA's role as the protector of the American public," he added, noting that he has many conversations with people who insist that fewer regulations are always conducive to a better business environment.
"We must not shortchange the standards that have provided safe and effective medical products," he concluded.
Janet Trunzo, SVP of medical device industry group AdvaMed, said afterward that AdvaMed's priorities are aligned with Ostroff's, noting that industry needs to engage with FDA so that the user fee negotiations can be delivered to Congress in the right time frame.