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This rule will revise 21 CFR 312.130, 314.430, 601.51, and 814.9 to clarify and expand the discretion of the Commissioner of the Food and Drug Administration regarding the public release of Complete Response Letters (CRLs) and not approvable letters. This rule will eliminate the longstanding presumption that the mere existence of a marketing application constitutes confidential commercial information, thereby enabling proactive disclosure of CRLs for unapproved products while maintaining appropriate redactions for trade secrets and personal private information.

Statement of Need:

CRLs and not approvable letters are summary documents FDA issues to sponsors when it completes its review cycle and determines that it cannot grant approval of an application in its current form. FDA describes in the letters the specific deficiencies identified during the review of safety and effectiveness data in the application which prevent it from granting approval of an application. CRLs and not approvable letters often contain confidential commercial information (CCI), trade secret information (TSI), (and personal private information (PPI)) that will be redacted prior to any public disclosure under the Trade Secrets Act and section 301(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

There are compelling public interests favoring the disclosure of CRL information and a good cause finding for this rule. Sponsors can leverage this valuable information to avoid common missteps and to provide enhanced predictability leading to more meaningful cures and treatments. Such efficiencies support the public interest in the availability, safety, and effectiveness of medical products and their efficient entry onto the market. Information related to the safety and effectiveness (and timeliness) of treatments is an issue of the utmost importance to patients and their families, and healthcare professionals evaluating and recommending care for patients. In addition, greater transparency will help to ensure sponsors provide complete and contextualized information in public announcements and to investors and shareholders. FDA recognizes the tremendous public interest in the transparency and credibility of FDA decision-making. Restoring common sense and gold standard science to America’s public health system is an issue of paramount importance.

Summary of the Legal Basis:

FDA’s authority to release CRL information is derived from the Federal Freedom of Information Act (FOIA) at 5 U.S.C. 552(a), section 505(l) of the FD&C Act) at 21 U.S.C. 355(l), and FDA information disclosure regulations at 21 CFR part 20 and 21 CFR parts 312.130, 314.430, and 601.51.  Federal law and FDA regulations provide FDA significant discretion to disclose CRL information including certain safety and effectiveness deficiencies associated with a pending application, regardless of whether the application has been made public. See 21 U.S.C. 355(l)(1).  As set forth in 21 CFR 314.430(a)-(c), FDA’s statements and deliberations reflected in CRLs are not property of the sponsor and can be disclosed by FDA.

Alternatives:

There is no alternative method of changing the current regulatory structure to permit the disclosure of CRLs associated with applications whose existence has not been made public.  Amending 21 CFR parts 312.130, 314.430, 601.51, and 814.9 enables FDA to clarify and revise its longstanding presumption that the mere existence of an application is CCI and thus cannot be disclosed to the public, permitting the disclosure of CRLs related to otherwise non-public applications.

Anticipated Costs and Benefits:

The benefits of the proposed rule would be increased transparency into FDA decision-making on CRLs, which may help future sponsors avoid submitting applications with the deficiencies explained in the CRLs. The costs of the proposed rule include costs to read and understand both the rule and the CRLs to interested parties, as well as costs to redact and publish CRLs on FDA's website.

Risks:

TBD