Key Takeaways
- FDA Chief Counsel Robert Foster will move to a new role in HHS’s Office Of General Counsel overseeing the FDA, and Hilary Perkins will move from the Justice Department and become the FDA chief counsel as part of a new HHS OGC reorganization.
- The reorganization, which also includes closing six regional OGC offices, could indicate HHS will exert more control over the FDA.
- Perkins had experience in FDA litigation at DOJ, but legal experts said her positions in those cases should not be seen as indicative of her positions moving forward.
The US Food and Drug Administration may see more micromanaging of its work by the Trump Administration under a new Health and Human Services Department reorganization of its Office of the General Counsel (OGC).
A new Chief Counsel for Food, Research, and Drugs was created, who will supervise the FDA Chief Counsel, including the Food and Drug Division of the OGC, HHS Acting General Counsel Sean Keeny announced 11 March.
Robert Foster, who has been FDA’s chief counsel for less than a month, will assume the new role, which also includes oversight of the National Institutes of Health’s OGC branch.
Hilary Perkins will become FDA chief counsel and associate HHS deputy general counsel. She has been working in the Justice Department’s Consumer Protection Division since April 2019.
HHS also will consolidate its OGC regional offices from 10 to four as part of the reorganization.
HHS said the reorganization was designed to focus on HHS Secretary Robert F. Kennedy Jr.’s priorities.
Kennedy used the announcement to take another swing at the industry and FDA relationship. He described the staff changes as necessary to “return the agency to gold-standard science, evidence-based medicine and recalibrate its trajectory toward public health rather than industry profiteering.”
More Micromanaging Of The FDA?
The reorganization also could ensure Kennedy has more control over the work of HHS subagencies like the FDA.
“This particular reorganization seems to very much go in the direction of reduced autonomy and more direction from HHS,” said Howard Sklamberg, a partner at Arnold and Porter and a former FDA deputy commissioner for global regulatory operations and policy. Though Sklamberg cautioned that he had no inside knowledge of the plan’s intent.
“That could potentially be an important development because FDA’s chief counsel’s advice often plays a large role in how the agency acts,” Sklamberg said.
Some chief counsels have been more legally careful and some have been more legally aggressive in the stances they take and the options they give the FDA, Sklamberg explained.
By centralizing the FDA’s legal work more, “you reduce the odds that there’s going to be FDA legal pushback from an initiative that HHS wants done,” Sklamberg said.
Scott Gottlieb, who served as FDA commissioner during President Trump’s first term, also warned that the FDA would come under more White House control in a second Trump term.
Don’t Read Too Much Into Perkins' Previous DOJ Work
At the Justice Department, Perkins' was a trial attorney for a year and a half before being promoted to assistant director. Among the Consumer Protection Branch’s duties is to defend the FDA in civil litigation, as well as investigate clinical trial fraud and drug and medical device manufacturers selling adulterated and misbranded products.
In the role Perkins would have worked on most of the briefs in FDA civil cases, including the recent mifepristone litigation, likely giving her more food and drug law experience than her predecessor Foster.
But legal experts said Perkins' role in those cases will not necessarily dictate her positions now that she is in a political, rather than a career, role, which comes with more decision making authority.
“I think its premature to read into the fact that she was on the papers,” in two key mifepristone cases, said Eva Temkin, a partner at Arnold and Porter and former associate FDA chief counsel.
“Lawyers have clients and they take positions that are going to advance the client’s interests,” Sklamberg said. “That’s what lawyers have to do ethically.”
“If somebody really doesn’t like the positions that the client takes they can always get a new job,” he added. “But I think there are plenty of examples of people taking a position representing a client, whether it’s the Justice Department or a private client, that they then in a different role end up taking a different position. That happens all the time.”
Prior to her work at DOJ, Perkins was an associate at Jones Day for more than seven years. She previously clerked for Rhesa Barksdale, a senior judge at the US Court of Appeals for the Fifth Circuit, who was nominated by President George H. W. Bush. She received her law degree from the University of Georgia in 2010, according to her LinkedIn profile.
Top House Democrats, Reps. Frank Pallone of NJ and Richard Neal of Massachusetts, who are members of the committees that oversee HHS and the FDA, criticized HHS’ closure of the regional OGC locations on 12 March. They said the offices are “charged with rooting out fraud and protecting our seniors.”