FDA came under fire from Rep. Buddy Carter (R-GA) Tuesday (Jan. 30) for what he alleges is the agency's use of guidance documents as the basis for compounding enforcement actions. Carter’s concerns were buoyed by a new policy from the Department of Justice which bars use of guidance to create binding standards, or to take enforcement action based solely on noncompliance with guidance -- although there is some debate as to how that policy will impact FDA.
Carter, who has been one of the most outspoken members of Congress against FDA’s stance on office use compounding, also took FDA to task for ignoring appropriations language directing it to change course. Gottlieb largely punted on the issue, but in a separate line of questioning indicated that the compounding office is underfunded.
“How are you justifying that you're going to use guidance policy for rulemaking here?” Carter asked Gottlieb during a Energy & Commerce health subcommittee hearing held Tuesday on implementation of the compounding law.
Gottlieb maintained that FDA’s guidance practices “generally have been used as a model for other agencies and for [the Office of Information and Regulatory Affairs].” But Carter pointed to an earlier exchange with Rep. Fred Upton (R-MI) which Carter believed implicated FDA in using guidance as binding policy.
“You even answered Representative Upton’s question about the guidance that you expected it and that you were using the guidance for enforcement. You’re essentially saying that this guidance is going to be enforced even though the DOJ has been told that no it cannot be converted into rulemaking,” Carter said.
Gottlieb did say that FDA will tailor its enforcement approach based on how it settles the issue of what drugs will be eligible for bulk compounding.
“The question will then become well when will you take enforcement action solely on the basis of that issue because it’s one thing for us to put out a guidance -- if people don't follow our guidance, we have to take enforcement action and that’s where I mentioned that we are going to relook at our protocols and how we prioritize our enforcement activity on the basis of those kind of considerations as well,” Gottlieb told Upton earlier in Tuesday’s hearing.
But Gottlieb rebutted Carter, arguing that the guidance is not the basis of enforcement actions, but rather the underlying statute is. “We can take enforcement action now. We don't need the guidance document in order to take the enforcement action. The guidance document is a way to provide public discussion around how we intend to take our enforcement action so we can both inform the public as well as learn from the public,” Gottlieb said.
Carter has long pushed for FDA to go through notice-and-comment rule making to implement the Drug Quality and Security Act (DQSA). Legislation by Reps. Morgan Griffith (R-VA) and Henry Cuellar (D-TX), Preserving Patient Access to Compounded Medications Act, which Carter cosponsored, would mandate FDA implement DQSA via rulemaking.
However, Carter’s push on Tuesday took on new significance, he believed, based on a Jan. 25 memo from the Office of the Associate Attorney General barring use of guidance documents to create binding policy. Carter admitted that he had not read the memo and that he was unsure whether it only applied to DOJ.
One attorney argued that the DOJ memo could impact FDA’s use of guidances, particularly when violation of a guidance lands a party in court for an alleged False Claims Act violation. “At first blush, this new guidance will have immediate and profound effects on actions brought by the government against health care companies under the False Claims Act. Too many of those actions are premised on no actual false statement and no actual violation of a statute or regulation. Instead, these FCA cases have been permitted to go forward and exercise their in terrorem effect based on some vague violation of vague FDA guidances,” Stephen McConnell, partner at ReedSmith, wrote in a recent Drug and Device Law blog.
Use of guidances has been under increased scrutiny from multiple agencies. OIRA Director Neomi Rao said Friday that OIRA is “trying to crack down on bad regulatory practices and make sure that agencies are proceeding in a manner that is consistent with law,” naming regulating via guidance as one such bad practice.
Carter also questioned Gottlieb on why the agency has ignored appropriations language urging it to reverse course on office-use compounding. “It’s my understanding that not once, not twice but three times, through appropriations language that the FDA has been instructed to revisit this,” Carter said. “Why do you ignore these? Why have you not ignored it once, not twice but three times? I don’t get it,” Carter said.
Gottlieb punted on the question, saying the language was included before he took FDA's helm but he is happy to talk with anyone in Congress about the statute.
In addition to language urging FDA to reverse course, one group at the center of the compounding fight, the International Academy of Compounding Pharmacists, had urged appropriators to block funding for implementation of FDA's office-use compounding guidance.
Gottlieb signaled Tuesday that funding for FDA’s compounding policy shop is sparse. “This is a program where we do operate by in some cases begging, borrowing and stealing from other parts of the agency,” Gottlieb said to Rep. Jan Schakowsky (D-IL) earlier in the hearing.
It is unclear whether the dispute with appropriations has in any way factored into FDA’s resource situation, and Gottlieb did not connect the two. IACP could not be reached for comment on whether it believes the contentious relationship between FDA and appropriators over office use compounding has in any way prevented the agency from getting the robust funding it needs for that office, and if so, whether IACP feels at all responsible for that.
It does appear, however, that the relationship between IACP and Gottlieb is shaky. IACP Vice President Shawn Hodges during the hearing called out FDA for allegedly ignoring requests for a meeting.
“We have some ideas about what we can do to ensure the quality and access but we are looking for a sit down with commissioner. We’ve requested this year, years prior we’ve sent letters and we’re not getting a response,” Hodges said.
Hodges’ comment led Griffith, who has disagreed fervently with Gottlieb on the issue of office use, to compliment the commissioner for his openness.
Despite a tongue lashing from Carter, one compounding attorney gave Gottlieb’s handling of nearly two hours of questioning rave reviews. “Gottlieb is doing a remarkable job and is playing chess to Congress' checkers. The fact that he's a Trump appointee getting uniform praise from the D side of the Committee speaks volumes. And he maneuvered as well as I could've expected on the office use debate,” the attorney said. -- Nicholas Florko (nflorko@iwpnews.com)
