Academics and Researchers Raise Concerns With FDA’s Plan for ‘Integrated Reviews’

Regulatory NewsRegulatory News | 28 August 2019 |  By 

More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the world are calling on the US Food and Drug Administration (FDA) to not replace its original reviews of medical products with an “integrated review” because of the valuable information that would be lost.

The researchers claimed that such a shift would deprive them of information and data on the clinical studies and trials submitted to FDA, information on the postmarketing requirements, and reviewer concerns with an application that might not be included in a summary document like the integrated review, among other important details.

“The FDA should not replace individual reviews with an integrated review. Rather, an additional document that summarizes the individual reviews can be published, as FDA has already been doing in publishing ‘Summary Review’ documents,” the researchers wrote.

Similarly, nonprofit Public Citizen said it “strongly objects” to FDA’s proposal, which was first explained in a June Federal Register notice. “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,” Public Citizen said.

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

Industry group BIO, however, said the new integrated template is an improvement over what the agency offers now, but also cautioned FDA “to strictly limit deletions to the information repeated across review documents rather than information that FDA deems to not be important to external entities.”

BIO offered the example of FDA recently trimming the content of publicly posted action packages, which led to the elimination of “a significant number” of meeting minutes. Industry group PhRMA also said it is important for FDA to ensure that the combination of the integrated review document and its appendices "is no less comprehensive than the existing documentation that is posted on Drugs@FDA."

BIO added: “These documents for non-milestone development phase meetings, midcycle communications, and late-cycle meetings are important for stakeholders’ understanding of the evolution of FDA’s thinking during the development program and throughout the Agency’s review of an application. Likewise, administrative and correspondence documents should continue to be made available.”

On the topic of FDA continuing to release sponsors’ clinical study reports (CSRs), which the agency is considering ending, the academics and researchers also disagreed with BIO on what to do.

The academics and researchers offered their support for FDA to continue its efforts to release CSRs, even though only one has been released so far. But BIO and PhRMA said that the release of CSRs should not be pursued by the agency.

BIO also called on FDA to work with the European Medicines Agency and Health Canada to better align its transparency efforts.


Updated with comments from Flatiron Health and PhRMA.


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