FDA Speeds Up Release of Drug Approval Information 
​[Posted on: Thursday, July 20, 2017]

This week FDA announced a revised internal procedure to release review information on approved drugs within 3-5 business days after approval. This enhancement of the existing procedures greatly increases the transparency of FDA review process to both the public and industry. FDA reviews are an indispensable educational tool for other developers who may be working on similar drugs, indication, and/or with the same reviewers. It gives a list of the key development steps, and critical factors that influenced the reviewers to finally approve the drug. This unique insight into the review process is very helpful to strategize future applications for similar drugs and even new molecular entities, and forms the backbone of most regulatory intelligence programs. FDA’s Summary Basis for Approval (SBA), also called “Action Packages”, are the most detailed of any regulatory agency in the World released publicly, and are eagerly sought after by industry after each new approval. For almost 20 years, FDA has had a policy of publicly releasing new drug approval notices but there used to be a delay of several weeks to even months before all information could be released. The process was driven to a large extent by the Freedom of Information (FOI) requests by interested parties with the applications with FOI requests getting prioritized for release. Before release of any information, FDA is required to appropriately redact the documents to assure compliance with FDA’s policy for public disclosure per 21 CFR 20. FDA does not disclose information that would affect an individual’s privacy, trade secrets and confidential commercial or financial information, and any information that may disrupt frank internal policy deliberations and regulatory activities. The documents need to be vetted by about five different departments within FDA before release. The process had gotten better in the last few years particularly for high profile products and this revised policy aims to standardize the practice. Under the revised policy, FDA will release the approval letter, approved labeling, approved REMS, and SBA documents within 3 business days for most new molecular entities and BLAs reviewed by CDER, and never later than 15 days post approval for every approved drug. The information will be available online at the Drugs@FDA site. Although this policy applies to decision by CDER and not to those by the Biologics and Device reviewers, similar policies for all FDA-approved products could be coming soon as well in the overall push to transparency.