HHS statement jeopardizes litigation, undermines FDA independence, agency sources say
HHS insiders view Azar’s memo and agency’s statement as a political play that could have far-reaching consequences
An HHS statement issued Sunday about HHS Secretary Alex Azar’s consolidation of power over rulemaking creates legal jeopardy for FDA in pending litigation, mischaracterizes the agency’s rulemaking process and incorrectly minimizes the importance of Azar’s action, according to FDA sources.
The statement, along with the memo it seeks to justify, could bolster legal arguments that thousands of rules issued from 2001 to 2018 by FDA and other HHS agencies are invalid. ...