By Norma Skolnik, Independent Consultant
With the aim of overhauling the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey recently sponsored bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act of 2018, S.2315. The bill, which has already passed in the House of Representatives, was approved by the Senate Health, Education, Labor, and Pensions committee on April 24, 2018, and was received by the Senate at large on July 17, 2018. A previous bill, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017, authored by Representative Bob Latta (R-OR) and others, was introduced over a year ago.
As most people know, the current monograph system, which was implemented in 1972, has received much criticism and there have been several prior efforts to revise what’s been called an outdated “broken system”. The current monograph system’s drawbacks include the slow rulemaking process (many OTC drugs are marketed under incomplete monographs), the inability to swiftly and promptly address safety issues, and barriers to innovation (eligibility is largely limited to active ingredients that were marketed before 1972). In addition, FDA has acknowledged that it currently lacks the resources to effectively regulate all OTC monograph products.
The proposed bill is intended to speed up the current slow and time-consuming regulatory procedures by introducing the administrative order process to replace the current rulemaking procedures. It provides options for manufacturers to request administrative orders and for FDA to initiate administrative orders on its own initiative as well as in response to a citizens’ petition.
The S2315 bill would also establish a process for the introduction of new OTC products that are marketed without an approved New Drug Application. This legislation would authorize the agency to grant 2 years of product differentiation and exclusive market protection for certain qualifying OTC drugs, thus delaying the entry of other versions of the same qualifying OTC product.
The bill also includes provisions that would provide FDA with the authority to take rapid action in the event of safety issues with OTC drugs and requires that FDA re-evaluate the OTC cold and cough monograph with respect to children under the age of six and report annually to Congress on the progress of this evaluation. This was prompted by a 2007 internal review that linked the deaths of 54 children younger than 6 years to the use of OTC decongestants and cough medications.
Additionally, the new legislation will help manufacturers who wish to develop innovative products, for example, by adding new ingredients or creating new dosage forms of existing OTC drugs. It should provide a more streamlined regulatory pathway for review of innovations within the OTC Monograph system, accommodating marketplace innovations, such as new uses for ingredients, dosage forms, and other advancements. It should also provide a mechanism to encourage investment in data needed for significant innovations.
Reforming the OTC monograph system should benefit consumers and give FDA the resources that it needs to provide effective oversight of these widely used drug products.
The proposed legislation updates the monograph process by specifically adding a new section to the Federal Food, Drug, and Cosmetic Act (FFD & C) to implement the following:
- Move away from the cumbersome current monograph finalization process to an “administrative order” procedure. The system for future changes to Monographs would be through the administrative order procedure with an opportunity for development meetings or other consultations, comment on proposed orders, and dispute resolution protections
- Include by reference existing OTC Review Final Monographs and deem final all existing Tentative Final Monographs by statute
- Create new pathways to innovation for monograph products, where none currently exits
- Ensure that the new drug approval pathway and other nonprescription drugs otherwise lawfully marketed are not affected
- Create a mechanism for faster OTC drug safety label changes;
Importantly, the bill provides FDA with the authority to collect user fees to help cover much of the costs of updating the regulatory system and provide the necessary resources to evaluate and monitor the OTC drug market. It’s hoped that the user fees will provide FDA with the funding and staff required to better oversee OTC drug compliance and build a critical IT/electronic infrastructure. This bill differs from previous versions because of its’ exclusivity provision.
The OTC Drug Safety, Innovation, and Reform Act is now awaiting Senate action. There is a great deal of bipartisan support for this bill, including from the American Academy of Allergy, Asthma & Immunology, the American Dental Association, and the American Academy of Pediatrics, who have urged passage because of the need to overhaul and modify pediatric dosing for OTC drugs, particularly OTC cough and cold drugs. It’s also been supported by the Consumer Healthcare Products Association (CHPA), the leading U.S. trade association representing OTC drug manufacturers and marketers. However, although it has widespread support and appears likely to pass, this is not a “must pass” bill like other existing user fee legislation. When it does pass, this legislation will have an enormous impact on the OTC drug industry in this country.