OND Director: New Approval Summaries Will Require FOIAs for Some Currently Available Data

Regulatory NewsRegulatory News | 25 September 2019 |  By 

Peter Stein (photo courtesy of FDA)

Closing out RAPS’ Regulatory Convergence on Tuesday afternoon, Peter Stein, director of the US Food and Drug Administration’s (FDA) Office of New Drugs (OND), confirmed to attendees that sponsors and other interested stakeholders looking to retrieve some of the data currently available in FDA-released drug approval packages would need to use the Freedom of Information Act (FOIA) to obtain some of that information under a new plan.

While not getting into the specifics of what would need to be FOIA-ed, the confirmation from Stein followed two pointed questions from an attendee asking for clarification as FDA’s Federal Register notice announcing this proposed shift to so-called “integrated reviews,” which would include summaries and highlights of drug approvals, made no mention that FOIAs would be necessary.

RAPS Board Member Jethro Ekuta also questioned FDA’s decision to move in this direction with the new summaries, saying, “This is just another administrative layer that I don’t understand.”

Ekuta clarified to Focus: "My comment was basically around the fact that the proposed organization of the Summary Basis of Approval (SBA) represents an important improvement to the existing format; however, the proposal to move certain components of the SBA to an appendix that can only be accessed to the use of FOIA would add another layer of administrative burden both the FDA and industry. Since the FDA would have already generated these documents and industry is likely to request these documents routinely, the additional administrative requirement would have no added benefit. The recommendation is for the FDA to leave these documents in the appendix so that they are accessible as they are today and as proposed BUT not require a request via FOIA to access them."

Responding to the comments, Stein told attendees he would take them into consideration and bring them back to the agency, but he also countered that the summaries and new layout would provide “a great deal of the data that we used.”

Previous pushback from both academia and industry raised concerns with FDA’s shift, which the agency said would increase transparency, but which commenters maintain would not.

Late last month, more than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities worldwide called on FDA to not replace its original reviews of medical products with these integrated reviews because of the valuable information that would be lost.

“This ill-conceived proposal would, at the least, be a major step backwards in agency transparency with respect to the data that the agency relies on when approving new drugs or biologics and the agency’s assessment of these data,” nonprofit Public Citizen added.

Health technology company Flatiron Health also noted that some of the sections in the original document appear to be missing in the new summary.

"We also note that the new document is considerably shorter than the original, which suggests that some potentially useful content may be lost in the new format. We urge FDA to ensure that highly valuable insight into reviewers’ thinking is retained in the new integrated review format. We are particularly interested in ensuring that any 'consultative' reviews from experts outside the core review team are included in the integrated summary review or otherwise accessible," Flatiron said.

Article updated on 9/25/19 with comment from Ekuta.


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Tags: approval, FDA, FOIA, OND

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