Regulatory Focus™ > News Articles > 2019 > 6 > FDA Plots Shift Away From CSR Pilot to Forge New Transparency on Drug Approval Process

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Posted 26 June 2019 | By Zachary Brennan 

FDA Plots Shift Away From CSR Pilot to Forge New Transparency on Drug Approval Process

2720 The US Food and Drug Administration (FDA) on Wednesday sought comments on a new effort to provide more clarity on the agency’s pharmaceutical application review and decision-making process.

FDA highlighted two efforts for which it’s seeking further comment: A fledgling pilot program launched in January 2018 that sought to provide more transparency on sponsors’ clinical study reports (CSRs) but only resulted in the release of one CSR, and a new integrated review template, currently being implemented, that can better convey FDA’s analysis and decision-making in drug approvals.

Because of the issues associated with the CSR pilot (FDA notes that Janssen was the only sponsor that agreed to participate), the agency is considering whether to focus its efforts to better communicate the basis for drug approvals on the development of these new integrated review documents, rather than on the release of CSRs.

To illustrate the new integrated review template, which has three main components — an executive summary (including FDA’s benefit-risk determination), an interdisciplinary assessment, and appendices (containing assessments and analyses that are supportive to key facts/data) — FDA rewrote the original review for Merck’s Pifeltro (doravirine) and Delstrigo (doravirine, lamivudine, and tenofovir disoproxil fumarate) to provide an example. 

“This new review template would replace the current documentation where each discipline provides a separate application review document. The updated template would be a collaborative document with input from clinical, clinical pharmacology, biostatistics, toxicology reviewers, and other disciplines based upon the issues raised by the application. FDA believes this program will also meet the goal of effectively communicating the basis for new drug approvals,” the agency said.

The new review process and template were developed under the New Drugs Regulatory Program Modernization, which is part of an effort to enhance the new drugs regulatory program through 2020. Other initiatives related to this modernization deal with speeding IND reviews, new post-market safety management processes, new staffing processes and restructuring the clinical offices and divisions within FDA’s Office of New Drugs.

“The proposed changes increase the number of offices that oversee our review divisions from six to eight - and increases the number of clinical review divisions from our current 18 divisions to 26 plus seven divisions of pharmacology/toxicology,” FDA said.

And as far as transparency at the agency goes, when former FDA Commissioner Scott Gottlieb announced the CSR pilot, he also mentioned the possibility of releasing certain redacted complete response letters (CRLs) to help inform the public about how a drug was rejected by the agency. But FDA has not further discussed the release of CRLs.

In terms of what FDA wants to hear from stakeholders on the new integrated review and template, the agency asks:

“1. How does the new format of the integrated review inform your knowledge of FDA’s basis for making decisions?

2. How does the usability and accessibility of information in the new integrated review compare to the original review posted on FDA’s website?

3. How could the information provided in the new integrated review format be used, if at all?

4. What do you believe would be the potential advantages and disadvantages of posting review documents in this format?

5. Based on the integrated review, were the issues that concerned the review team clear and understandable? If so, what helped achieve this? If not, what can be improved?

6. Is there important information in the integrated review that is difficult to locate or should be added?”

Federal Register


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