FDA Can’t Always Get What It Wants…So It Asks Congress

June 7, 2022By Jeffrey N. Gibbs & Sara W. Koblitz

As the User Fee Acts move through Congress, it has been clear that FDA is using them as a vehicle to legislatively overturn some big court losses over the last few years.  As faithful readers of our blog know, FDA’s broad interpretations of its governing statute have not always fared that well in the courts.  In each of three cases—Genus v. FDA, Catalyst Pharms., Inc. v. Becerra, and Judge Rotenberg Educ. Ctr., Inc. v. FDA—the D.C. Circuit and the Eleventh Circuit Court of Appeals has limited the Agency’s discretion to interpret the statute as it sees fit.  Unsurprisingly, FDA hasn’t been too happy with these decisions and is now looking to Congress for a legislative fix to each of these losses.

While industry has been celebrating its judicial success, FDA has been quietly lobbying Congress to revise its governing statutes to reverse the agency’s losses.  This language was added without hearings or any public input.  This is not how the system is supposed to work.  If it were, the public notice provisions embedded into the Administrative Procedure Act would have no value; the agency could circumvent public input by going to Congress.  But that’s exactly what FDA is doing here.

Underscoring the unfairness of the legislative fix, several of the plaintiffs in cases overturning FDA interpretation were not even aware of the pending legislation until days before it went to committee for a vote.  This end-run obviates the purpose of public input and undermines democracy.  It also leads to bad outcomes, since Congress hears from a single stakeholder: FDA.  Though the American system of government is built to prevent the concentration of power in a single body, FDA’s actions here threaten the administrative process and basic notions of transparency, and, in the case of the JRC decision, federalism, as explained in this article by Rich Samp of the New Civil Liberties Alliance.

Hyman, Phelps & McNamara, P.C. Directors Jeffrey N. Gibbs and Sara W. Koblitz discuss FDA’s activities with regard to these three cases in an article published by the Washington Legal Foundation last week.  Gibbs and Koblitz raise concerns about the use of the legislative fix to negate the judiciary and eliminate the public’s participation in setting policy.  Unfortunately for industry, it seems that when FDA can’t get what it wants, it will go to Congress and lobby.