Krista Carver's commentary was included in an article appearing in The Pink Sheet about the FDA's new authority under the Food and Drug Omnibus Reform Act (FDORA) to require that studies be started prior to approval, or within some specified period of time thereafter. According to the article, the FDA's new authority may embolden reviewers to take a harder stand with sponsors when it comes to confirmatory trial planning and initiation, although much will depend on the product itself and the therapeutic setting
Krista believed that with the new legislative power on confirmatory studies, coupled with clear goals under the prescription drug user fee program around communicating with sponsors on postmarketing requirements, she thought "it's quite possible that that we will see this more often, that FDA will use its codified authority ... in ensuring that studies are underway."
The article also cites the importance of the statutory language that the FDA "may" require studies be underway at the time of accelerated approval, not that it "must."
"I view that authority as codifying existing FDA regulations and guidance and confirming that FDA has flexibility to allow approvals both before and after the confirmatory trial is initiated," Krista remarked.
Krista added, "I think from a public health perspective that that's a good approach to ensure that patients with serious conditions can get timely access to therapies, even if the accelerated approval approach becomes evident later in the development and review process." In addition, Krista stated, "I do think it's critical that the statute retains the agency the flexibility to decide that's not appropriate in a particular case," such as "where there has been a lot of back and forth on the confirmatory study design such that it's not realistic to expect that the study would have started at the time of approval and patients should not be denied access to what otherwise would be a safe and effective therapy because of that issue."
"But on the other hand, we understand that it was important to the agency that it have clear authority to require studies would be underway at the time of approval where appropriate," Krista continued. "That was something that was reflected in agency regulation and guidance already. So I think industry is familiar with that approach."
Krista further explained that an important implementation issue will be how the agency marries this new authority under FDORA with the new performance goals on postmarketing requirements under the seventh iteration of the Prescription Drug User Fee Act. "I think that it's very important that FDA ensure that it has a process in place that enables streamlined and timely feedback on postmarketing requirements to make the codified approach on postmarket study requirements work," she said.
The six-and eight-week intervals for postmarket requirements communications prior to approval are "a pretty tight timeline to get everything into place for a postmarketing study and make sure that it's able to timely start," Krista explained. "And so I think it's all the more important that that those goals be met and that FDA aim to, in a very timely fashion, communicate with sponsors about these studies so they can be started as soon as possible."
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