PwC Analysis: Fewer New Regulations in 2017, But No Major Course Change at FDA

Posted 22 February 2018 | By Michael Mezher 

PwC Analysis: Fewer New Regulations in 2017, But No Major Course Change at FDA

While 2017 was a standout year for the US Food and Drug Administration (FDA), many aspects of the agency's work were business as usual in a year that saw a new president and new leadership at FDA.

Shortly after his inauguration, President Donald Trump signed an executive order requiring government agencies to eliminate two regulations for every new one they created and told pharmaceutical industry CEOs that his administration would be "cutting regulations at a level no one has ever seen before."

But despite Trump's promises to upend things at FDA, his choice for FDA Commissioner, Scott Gottlieb, has thus far maintained many of the agency's longstanding initiatives and has withdrawn relatively few rules and regulations, though the agency has held consultations on what other regulations should be modified or repealed.

These observations are echoed in a new report from PriceWaterhouseCoopers' (PwC) Health Research Institute that finds that many of FDA's 2017 highlights are continuations of earlier efforts or reflect long-term trends rather than abrupt or unprecedented changes as Trump seemed to hint at.

And according to PwC's analysis, 2017 saw the lowest number of economically significant new regulations in the last 20 years. The agency also promulgated fewer new and proposed regulations than in all but four of those years, though the regulation totals included FDA's work in food, devices and other industries outside of biopharma.

It may be too early to tell whether Gottlieb will make more dramatic changes at FDA, as PwC notes that it often takes more than a year to develop regulations that will have a substantial impact.

In other areas, the agency's activity was similar to recent years, or continued along trends seen over the course of the Obama administration.

For instance, while the agency issued fewer draft and final guidances in 2017 than in 2016, a drop from 256 to 174, the release of new guidances was less than one off from the previous five year average of 173.2.

And while FDA saw record high approval numbers for drugs, generic drugs and orphan drugs, those approvals continued along trends seen over the past decade.

On the enforcement side, FDA issued fewer warning letters and untitled letters over good manufacturing practice (GMP) and advertising and promotion issues than in recent years, though the agency issued more warning letters to drugmakers in particular than in any of the previous four years.


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