FDA on Jan. 15, 1985, issued a proposed rule that it called a tentative final monograph on laxative drug products for OTC use, in which the agency tentatively accepted the recommendations of an expert advisory committee.

But after the expert panel submitted its report, the agency learned of animal studies that raised questions about the panel's recommendations on docusate laxatives.

Rather than delay finalization of the laxatives monograph, the agency removed all discussion of the safety and effectiveness of docusate salts from it.

More than eight years later, after reviewing additional data, FDA on Sept. 2, 1993, proposed to amend the laxatives tentative final monograph with a determination that docusate salts are generally recognized as safe and effective, and not misbranded.

Currently, nearly 13 years after the proposed amendment and more than 31 years after the initial proposal, the laxatives monograph still has not been finalized.

The time that FDA has needed to establish a laxatives monograph is not unusual for the OTC monograph program. The agency is reviewing the program to identify areas of improvement and is discussing with the industry whether establishing user fees would help. (Also see "OTC Monograph User Fees: FDA-Industry Talks Move From Basics To Details" - Pink Sheet, 2 August, 2016.)

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