People seeking dependable medicines have an interest in timely decisions and in careful examination of evidence. FDA’s November 23, 2016 rule addressed the timing side of that responsibility for specified non-sunscreen over-the-counter time-and-extent applications. It did not declare an ingredient safe merely because an application entered the process or a deadline approached. [2016-28120][2016-07612]

The rule distinguished eligibility from the completeness of safety and effectiveness submissions, and both from the eventual regulatory judgment. FDA had 180 days from TEA submission for an eligibility decision and 90 days from the data submission for a filing determination. These were different duties with different starting events, not interchangeable signals that consumers could rely on a new treatment. [2016-28120][2016-07612]

In the April 4 proposal, FDA explained that screening and withdrawal provisions would make review more predictable and prevent attention from remaining tied to submissions no longer pursued. The final’s public performance metrics offered a way to examine whether specified actions occurred on time. Our stewardship reading is that visibility into the agency’s use of time matters, but a count of timely decisions cannot replace examination of their substance. [2016-28120][2016-07612]

The final was effective December 23, 2016. Its timeline section excluded sunscreen conditions and specified non-sunscreen TEAs submitted before November 27, 2014 under the statutory exception. Those limits prevent a narrow administrative reform from becoming a broad health promise. The proposal and final are one evidence chain, supporting an account of the agency’s framework rather than proof of safer products or fulfilled deadlines. [2016-28120][2016-07612]

Source documents

  1. Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applicationshttps://www.govinfo.gov/content/pkg/FR-2016-11-23/html/2016-28120.htm
  2. Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applicationshttps://www.govinfo.gov/content/pkg/FR-2016-04-04/html/2016-07612.htm