What Changes May Come to FDA in 2017
Mintz Levin attorneys Joanna Hawana and Bethany Hills says changes are likely to FDA in 2017, both arising from the election of Donald Trump and from approval of the 21st Century Cures Act and “must-pass” user fee legislation. Writing in an online blog post, the two say that while some of the trends they see could be affected by the selection of the next FDA commissioner, “it takes time and not an inconsiderable amount of buy-in from career agency staff to make major changes in longstanding programs and initiatives, so less politically controversial issues are unlikely to be revisited in the short-term.” Trends they are watching include:
- Regulations. It will remain to be seen, they say, what steps Congress takes under the Congressional Review Act to roll back final rules promulgated since 5/2016. But for any FDA regulations that remain in proposed rule form, they suggest it is not likely they will be finalized given the new administration’s avowed disdain for “government regulation” writ large. “Thus,” they write, “some of the rules listed in the agency’s fall 2016 unified regulatory agenda as pending a proposed regulation are likely to be taken off the table altogether.”
- Guidance. The attorneys say it is a simple matter for the next commissioner to order individual Centers and offices to withdraw either a final or draft guidance by providing written notice to affected parties in the Federal Register. “So,” they say, “several of the more controversial or legally questionable guidance documents may be withdrawn by FDA following the change in leadership. One good example here would be the recent draft guidance that creates a quality metrics reporting program for pharmaceutical manufacturers, as that guidance was not well-received by industry. At the same time, however, we could see relatively fast action by the new FDA leadership to issue guidance on certain subjects that current agency leadership has delayed or been hesitant to act upon even with significant and diverse stakeholder pressure. The prime example [is] guidance on the permissible scope of off-label communications by medical product manufacturers. Indeed, off-label communications and related enforcement are one area where we expect a significant policy change to be implemented by the Trump administration.”
- Enforcement. The post says that some enforcement priorities and initiatives are likely to change in the near term. “Although it is unlikely that the next administration will alter FDA’s enforcement activities and policing of serious public safety issues,” the attorneys write, “there may enter a more laissez-faire climate when it comes to enforcement of ‘victimless’ regulatory violations.
The post also says it is not likely there will be much attention from the new administration to the implementation of the Biologics Price Competition and Innovation Act, except perhaps to urge regulators to work more quickly and to help get more biosimilars to market.