According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:
Proposed Monograph Modifications
- Amending the topical antiseptic monograph to address consumer hand wash products (February 2013);
- Amending the OTC monograph addressing cough/cold drug products containing an oral bronchodilator (ephedrine and salts) in combination with any expectorant or any nasal decongestant (March 2013);
- Modifying the cough & cold product monograph to address safety and efficacy issues associated with pediatric cough and cold products (June 2013);
- Modifying the cough & cold product monograph to add the common cold indication to certain OTC antihistamine active ingredients (June 2013);
- Amending the topical antiseptic monograph to address consumer leave-on antiseptic products (July 2013);
- Proposing rulemaking to address the safety of sunscreen active ingredients (July 2013);
- Amending internal analgesic product monograph to address acetaminophen safety (August 2013);
- Proposing rulemaking to address active ingredients for sunscreen reviewed under time and extent applications (September 2013); and
- Amending internal analgesic product monograph to address products marketed for children under 2 years old and weight- and age-based dosing for children’s products (December 2013).
Proposed Post-Marketing Safety Obligation Modifications
- Addressing post marketing safety requirements for combination products (combinations of a drug, device, and/or biological product), to clarify that a combination product is subject to the reporting requirements associated with the type of marketing application under which the product is approved, licensed, or cleared, and to certain additional, specified reporting requirements depending on the types of constituent parts (drug, device, or biological product) of which it is comprised (April 2013)
Proposed cGMP Modifications
- Amending regulations regarding the control over components used in manufacturing finished pharmaceuticals (May 2013); and
- Clarifying and codifying the current good manufacturing practice (cGMP) requirements for combination products (combinations of a drug, device, and/or biological product), to ensure consistency and appropriateness in the regulation of combination products and avoid the necessity to fully implement both drug cGMP regulations and device quality system regulations when manufacturing combination products (December 2013).
The cough/cold monograph amendments reflect collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC). According to FDA, “the objectives of the RCC monograph alignment working group are to conduct a pilot program to develop aligned monograph elements for a selected over-the-counter drug category (e.g., aligned directions, warnings, indications, and conditions of use) and subsequently, develop recommendations to determine the feasibility of an ongoing mechanism for alignment in review and adoption of these OTC drug monograph elements.”
FDA also is expected to closely monitor monograph and firm registration compliance. Notably, the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, now requires drug firms to submit annual establishment registrations in the period from October 1st to December 31st of each calendar year. In addition, at the time of annual registration, firms must list any drugs not previously listed. Drug establishment registration information allows FDA to identify all manufacturing facilities involved in producing drugs that are in commercial distribution in the United States, and drug listing information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Drugs that are manufactured in establishments that are not properly registered and drugs that are not properly listed as required are misbranded and may be subject to regulatory action.