New Year, New Administration, New FDA and New Cures: Approvals and Enforcement Outlook for 2017

by Mark Senak

Every U.S. federal agency is facing the potential for considerable change given a new Administration taking office this month, setting into motion the process whereby new heads of bureaucracies assume responsibility and bring different priorities and agendas to their respective roles. But one – the Food and Drug Administration – which regulates one-fifth of the U.S. economy – is also facing the implementation of sweeping new legislation – the 21st Century Cures Act (Cures) passed into law late last year.

That single fact alone makes the choice of a new FDA Commissioner all the more important and inflates the level of change we are likely to see following the election.

Cures is very long and broadly covers a good deal of ground, but if you were going to boil it down to two chief themes from the legislation it would be to: (1) speed up the pathway for approvals, particularly for rare diseases; and (2) to reduce the regulatory burden industry faces in getting new products into the marketplace.

Will Cures and the presence of a new commissioner in fact speed up approvals? In fact, after a banner year where the agency approved 45 new molecular entities in 2015, this past year saw a significant drop to 22 approvals. But the rate of approvals is not solely reliant on FDA – it has to do with company pipelines and timing for filing.

In past years, the agency has had the means to accomplish many of the goals of the legislation – efforts that have been paying off. In 2012, FDA began its program to designate some therapies with “Breakthrough Therapy Status” meaning that FDA grants candidate drugs expedited review if they are considered to be meaningful advancements for life-threatening conditions. In 2013, there were 3 drugs approved with this designation – but by 2015 there were 21 and last year there were 14. In addition, there has been an uptick in the approvals for drugs that treat rare conditions. Breakthrough Therapy Status is a result of 2012 legislation – the Food and Drug Safety and Innovation Act (FDASIA) – and the track record exemplifies the fact that there is a time lag between legislation being passed and the time when it has a real impact. So while FDA has not been approving more drugs this year, it may be approving them faster.

There has been speculation about who a new FDA Commissioner may be, but whoever is chosen, one thing seems likely. A new commissioner will likely work to enhance and facilitate the speed around new approvals, and seek to remove many of the regulatory restraints on industry. On the subject of approvals, the interpretation of how Cures should be implemented will be key to impacting how often and under what conditions approvals will be enhanced, but the impact is not likely to be strongly felt in 2017. Rather, the ground will be laid for an impact in 2018. Change does not come quickly to FDA.

FDA Enforcement

The Office of Prescription Drug Promotion (OPDP), which oversees communications by companies around medical products, has not taken many enforcement actions over the past several years. In 2016 (through December 1), OPDP had issued only five letters, the lowest number in any year. However, in December there was a sudden uptick with the issuance of 6 letters, bringing the 2016 number to 11, which is exactly on par with the past few years. In an era with a hallmark of less regulation, there is no reason to think that a new FDA Commissioner will cause this to change.

In fact, in an era where less enforcement is likely the norm, the area this year to perhaps watch is the role FDA takes with respect to the issue of communication around off-label uses. Some have speculated that in light of a late 2016 hearing on the issue, FDA may already be poised to liberalize its point of view in this regard. If a new commissioner with a “less is more” attitude about regulation assumes the helm, that speculation may well become reality.