FDA Regulations at 20-year low in 2017

The U.S. Food and Drug Administration (FDA) appears to have complied with the Trump administration’s request that the agency issue fewer regulations. In 2017, the FDA issued only six new significant regulatory actions, none of which involved biopharma. This represents the lowest level in 20 years, according to an analysis by the Health Research Institute at PricewaterhouseCoopers (PwC).

Despite issuing few regulations, the agency continued to release draft and final guidance documents at a steady rate. This suggests that collective bureaucratic thinking on policy matters continues. There were 174 guidance documents issued last year – not much different than the annual average of 152 released during President Obama’s terms.

“Perhaps the most surprising finding of this research is that, amidst all of the turmoil and bluster in Washington, DC, 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, told STAT News.

Historically, FDA rulemaking has accelerated in the second year of presidential administrations.

Source: STAT News, February 28, 2018.