STAT | Pharmalot

At FDA, there’s stability, but few regulatory acts

Saul Loeb/AFP/Getty Images/File 2017

As the Trump administration settled in last year, the White House insisted on fewer regulations — and the Food and Drug Administration delivered, according to a new analysis.

Last year, regulatory actions taken by the agency were only a fraction of the number of actions taken during the Obama administration and in fact dropped to the lowest level of any time in the past 20 years, according to the Health Research Institute at PricewaterhouseCoopers, the consulting firm.

In all, the FDA issued just six new significant regulatory actions in 2017, compared with 30 during the previous year. Moreover, none of those half-dozen actions involved biopharma regulation, but there were 11 actions applicable to life sciences in 2016 and 13 such actions in 2015.


This does not mean, though, that the FDA has been silent on policy matters. The agency continued to issue draft and final guidance documents at a steady clip, which is, of course, a way to signal collective bureaucratic thinking on a topic. There is, however, nothing binding about this approach.

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Specifically, the FDA released draft and final guidance documents in 2017 at a fairly similar rate to previous years. There were 174 guidances issued last year, which was down from 256 released in 2016 and 192 that were pushed out the door in 2015. Still, the PwC analysis found that the number of guidances issued last year was not far from the annual average of 152 released during the Obama years.

“Perhaps the most surprising finding of this research is that, amidst all of the turmoil and bluster in Washington, D.C., the FDA has continued to be remarkably consistent in the way in which it operates,” Alexander Gaffney, a senior manager at the PwC Health Research Institute, wrote us.

“For the pharmaceutical industry, this stability is likely a welcome sign. Disruption can be costly, especially for an industry that spends huge amounts of money over many years trying to get their drugs approved.

“A predictable regulator can help facilitate investor comfort in the value of that investment.”


Nonetheless, FDA rulemaking could start accelerating, at least if history is any guide. PwC noted there was a 15.4 percent increase in “economically significant” regulations that were issued during the second year of the Obama administration, and a 100 percent jump during the Bush administration that preceded it.

You may recall that the FDA published its guidance agenda for the pharmaceutical industry, showing 98 guidance documents planned for release this year that span 18 categories, including two dozen that are considered procedural.

And there are 18 pharmaceutical regulations under various stages of development, although some of these may have been hatched years ago.

It is worth noting, by the way, that the steady stream of blog posts, speeches, and statements from Scott Gottlieb, the loquacious FDA commissioner, was not incorporated in the analysis.

In any event, pharma executives are counting on agency efforts to make their lives easier. Fifty-three percent of those surveyed in September said the FDA will accelerate review times for new drugs, and 51 percent see the same for generics. Just 5 percent to 7 percent thought review times would slow. Not surprisingly, 36 percent want approval standards streamlined, more than any other type of regulation.

Ed Silverman can be reached at Follow him on Twitter @Pharmalot. Follow Stat on Twitter @statnews.