FDA Annual Forecast

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Last FDA Posting Date: September 30, 2024 

Background 

The over-the-counter (OTC) monograph annual forecast is a nonbinding list, issued each year, of planned monograph activities that FDA intends to initiate over the ensuing 3 years. These planned monograph activities will generally include expected FDA-initiated proposed administrative orders (proposed orders) to add, remove, or change generally recognized as safe and effective (GRASE) conditions for OTC drug monographs including GRASE determinations for drugs marketed under 505G(a)(3) of the Federal Food, Drug and Cosmetic Act. Planned monograph activities may also include expected requests for data on specific topics to help inform future monograph activities. FDA’s decision-making regarding which activities it intends to initiate over the ensuing 3 years and in turn to place on the forecast is generally guided by public health priorities. FDA may consider information from a variety of sources including but not limited to literature, FDA Adverse Event Reporting System (FAERS), or data and information submitted to FDA in determining which activities it intends to initiate. The order of topics in the forecast does not reflect planned chronological order of FDA actions, or order of public health importance.

The first annual forecast was posted on September 30, 2022 with a second update posted on September 19, 2023. The most recent update was posted on September 30, 2024. 

Please note in the comments section, we have included the actual date that the Agency posted the planned event for tracking purposes

FDA Initiated Proposed OrdersOTC MonographComments
Risks Associated with Codeine-Containing Cough Medicine: Will address the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.M012First listed in September 2022
Pediatric Acetaminophen Dosing: Will address dosage strengths of oral, single ingredient pediatric acetaminophen products and propose addition of weight- and age-based dosing for children under age 12 years.M013First listed in September 2022
Risks Associated with Propylhexedrine Abuse and Misuse: Will propose addition of a warning for propylhexedrine-containing drug products to inform consumers of serious health risks with abuse and misuse.M012First listed in September 2022
Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and Oligohydramnios: Will propose updated pregnancy labeling for NSAID-containing drug products.M013First listed in September 2022
Oral Healthcare in Infants and Children: Will address the GRASE status of OTC oral health care drug products containing benzocaine and/or phenol preparations labeled for anesthetic/analgesic indications.M022First listed in September 2022
Risks Associated with use of Ipecac Syrup as OTC Poison Treatment: Will address the GRASE status of OTC ipecac labeled for poison treatmentM023First listed in September 2022
Pediatric Cough/Cold Dosing: Will re-assess the risks and benefits of cough/cold drug products in children under age 6 years.M012First listed in September 2022
Effectiveness of Phenylephrine as an oral DecongestantM012

First listed in September 2023. FDA Advisory Committee held on September 11-12, 2023 statement.

See Proposed Administrative Order listed below to amend OTC Monograph M012.

Call for Data

Anticaries Test Methods; Requesting data to support the inclusion of pH cycling test as an acceptable anticaries test methodM012First listed in September 2023

New Proposed Orders Based on the OTC Monograph Annual Forecast

Serious Skin Reactions Associated with Acetaminophen: Will propose to add skin allergy warning to labeling requirements for acetaminophen-containing drug products.M013First listed in September 2023. In June 2024 the agency posted a proposed amendment to M013 with supporting documents
Proposed Order to Amend M012 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human UseM012

This proposed order published on November 7, 2024 addresses the OTC Monograph Annual Forecast topic on the Effectiveness of Phenylephrine as an oral Decongestant.

This proposed order, if finalized, will amend OTC Monograph M012 to remove orally administered phenylephrine hydrochloride and phenylephrine bitartrate in an effervescent dosage as nasal decongestant active ingredients because they are not effective. The Agency has posted its Scientific Review documents that support its proposed administrative order.

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