FDA plots multi-day hearing to review 'dangling' accelerated approval that drugmaker refuses to pull
What happens when the FDA tells a company to pull a drug approved under its accelerated pathway because it didn’t prove to be effective in a confirmatory trial, and the company refuses?
That’s what is currently playing out between the FDA and Covis Pharma, which will duel it out during a final two-and-a-half-day virtual hearing set for next September or October, according to the latest letter from Celia Witten, FDA’s director of the Office of Cellular, Tissue and Gene Therapy and who’s presiding over the hearing.
It’s been almost 18 months since the FDA recommended that Covis Pharma withdraw its controversial drug Makena, and still the drug, which first won an accelerated approval in 2011 but failed a confirmatory trial in 2018, remains on the market.
In a show of fairness, the hearing will allow for both Covis and FDA’s Center for Drug Evaluation and Research to each make two-hour presentations, and both CDER and Covis will be given a full hour to ask questions after the opposing side makes its presentation. An additional four hours will be set aside for public comments, which will allow for the generic manufacturers of Makena to also speak.
“I must afford CDER and Covis an opportunity to ask questions after presentations by the public and reserve time for the advisory committee members and me to do so, as well,” Witten wrote to attorneys from both CDER and Covis. The third day (a half day) will allow for closing statements from both sides.
CDER said previously that Covis should not be allowed to present info on other accelerated approvals at the hearing, but Witten wrote that she’ll allow it to a certain degree, explaining:
I will not prohibit Covis from referencing other products granted accelerated approval as a means of shaping and framing its arguments and presentation at the hearing, though I encourage Covis to keep references to other products brief because any time spent discussing other products granted accelerated approval will take time away from Covis’s presentation on more pertinent and fundamental issues at the hearing.
However, Witten makes clear that the design of any future confirmatory trial(s) is not an issue to be decided as part of this hearing process.
And while CDER’s lawyer previously pushed back on the idea of using real-world evidence to support the case of Makena, Witten said she’ll allow Covis to present such data as “the availability and feasibility of certain study designs in light of existing data and information regarding Makena’s effectiveness might have some relevance in determining whether FDA should withdraw approval while additional confirmatory studies are conducted.”
Francesco Tallarico, general counsel at Covis, told Endpoints News via email that the company is not refusing the FDA’s rejection decision but that:
“The agency determined, based on the scientific data presented by Covis, that a hearing request was justified due to the existence of ‘specific challenges to the factual and scientific bases underlying CDER’s proposal’ and ‘genuine and substantial issues of fact appropriate for a hearing.’ The FDA was not required to grant a hearing but did so based on an independent review of the evidence presented by the company.”