On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory agency practice by substantially reducing the importance and significance of Guidance Documents for not only life sciences companies, but all industry segments. Although ironically the policy position was itself not effectuated by statute or notice-and-comment rule making, the statement in effect, reduces regulated industry’s ability to rely on government guidance.
Although Guidance Documents are implemented unilaterally by agencies without administrative law requirements of notice-and-comment rule making, these documents are essential for companies in fast-paced innovative industry segments — especially life sciences. Without the ability to “rely” on Guidance Documents as the accepted “thinking” of FDA and other regulatory Agencies, companies will face increased uncertainty in the market authorization, promotional activities, and manufacturing regulatory contexts. Finally, Guidance Documents put bad-actor companies “on notice” of what to expect from regulators. These documents are essential for consumer protection in a rapidly-changing industrial landscape, as well as a landscape littered with companies and individuals that would lie, cheat and steal for financial gain, and put the American public at risk.
See my LinkedIn post below: