FDA Annual Forecast

On September 19, 2023, FDA posted the ‘Annual Forecast for Planned Monograph Activities’, a nonbinding list, issued annually, describing planned monograph activities that FDA intends to address over the ensuing three years. FDA has described their decision-making regarding which activities to place on the forecast as “generally guided by public health priorities”. The order of topics in the forecast does not reflect planned chronological order of FDA actions, or order of public health importance.

A brief listing of the topics and proposed activity is included below.

For certain types of planned actions (e.g., FDA-initiated finalization of general recognition of safety and effectiveness (GRASE finalization), FDA may request data in advance of a proposed order.

A more detailed summary of each of the seven topics and proposed activities can be found by selecting the individual link.

Planned Proposed Safety Orders

  1. Risks Associated with Codeine-Containing Cough Medicine: Will address the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.
  2. 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.
  3. 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.
  4. Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and Oligohydramnios: Will propose updated pregnancy labeling for NSAID-containing drug products.
  5. 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.
  6. Serious Skin Reactions Associated with Acetaminophen: Will propose to add skin allergy warning to labeling requirements for acetaminophen-containing drug products.
  7. Risks Associated with use of Ipecac Syrup as OTC Poison Treatment: Will address the GRASE status of OTC ipecac labeled for poison treatment
  8. Pediatric Cough/Cold Dosing: Will re-assess the risks and benefits of cough/cold drug products in children under age 6 years.

Other Planned Proposed Orders

  1. Anticaries Test Methods: Will address test methods for anticaries drug products.
  2. Effectiveness of Phenylephrine as an Oral Decongestant Ingredient: Will address the GRASE status of OTC phenylephrine as an oral decongestant ingredient.

FDA has created a public-facing web portal (OTC Monographs@FDA) that lists proposed and final administrative orders that add, remove, or change conditions for an OTC monograph. This website will also facilitate the submission of comments and data from the public for proposed and interim final administrative orders, unless otherwise specified.