Provide Reviews with CRLs: Attorneys
Attorneys Deborah Livornese, JP Ellison, and Josephine Torrente (Hyman, Phelps & McNamara) say CDER should change its current process and provide access to complete agency drug reviews to sponsors who are issued a complete response letter (CRL) advising them of the reasons the agency cannot approve an application in its present form. Writing in their firm’s FDA Law Blog, the three say that biotech companies need to fully understand the deficiencies that FDA has identified in their application, so they can make a decision to address the CRL or appeal it.
“A CRL is, by its nature, a summary document that abbreviates the many months of review and independent analyses performed by a number of FDA disciplines such as medical, statistical, and clinical pharmacology, into a handful of pages,” the post says. “The actual detailed work performed by the FDA reviewers is embodied in various highly informative review documents that, by contrast, typically span several hundred pages. The applicant receives the CRL but is not provided the most instructive underlying reviews. Because of its typical brevity, the CRL is limited to a high-level description of deficiencies and suggested actions for addressing them. It cannot encompass all of the nuanced information needed to fully appreciate the division’s view or the basis for that view.”
Although companies can attend an end-of-review meeting, the attorneys write, such meetings are often too short to satisfactorily communicate the details of what may be more than one complex issue. “Failure to provide the reviews to the applicant strikes us as fundamentally unfair in addition to being inefficient,” the post says. “As a general legal matter, it is a well-accepted principle of administrative law that when an agency relies on scientific and technical data, it must provide adequate information regarding those data to allow critique of them.”
The post says the attorneys understand, based to some extent on agency lore, that CDER does not share the underlying reviews with applicants because it believes that disclosing them to the applicant would make the documents disclosable, at least in some respects, to third parties under the Freedom of Information Act (FOIA). “We believe that such an interpretation is incorrect and that FOIA case law does not require that outcome,” the attorneys counter.
The post concludes that a modification in CDER policy to allow an applicant access to the underlying reviews “could change the post-CRL process for the better for CDER and for the CRL recipients. At a minimum, the information would reduce the multiple requests to review divisions to provide further clarification, thereby reducing the drain on resources.”