Many of us have been waiting not-so patiently for FDA to begin implementing the over-the-counter (OTC) monograph reform provisions of the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (see our blog post here). While we are aware that behind the scenes the Office of Nonprescription Drugs has been busy hiring, training, reorganizing and otherwise working on implementation, apart from setting the amount of the new fees and related actions (see our blog post here), until very recently, little had been officially forthcoming from FDA under these provisions. Now FDA has taken several actions in the past few weeks that we describe below.
Deemed Final Administrative Orders
As part of the process of moving from the old rule-based monograph system to an administrative order framework, the CARES Act provides that in most cases a final monograph or tentative final monograph that establishes conditions of use for a drug described in section 505G(a)(1) or (2) of the FD&C Act is “deemed to be a final order”. These deemed final orders provide the current OTC drug monograph conditions that are in effect for each therapeutic category addressed by them.
As a first step in implementing this provision of the CARES Act, FDA issued a Federal Register notice on September 21, 2021, announcing the availability of the first group of deemed final administrative orders. In that notice, FDA also announced the establishment of a web portal, OTC Monographs@FDA, which provides access to the repository of final orders. FDA intends to make the deemed final orders available in batches on a rolling basis until all 32 orders are available in the repository. Their availability will be announced on the FDA website and FDA will not make additional announcements in the Federal Register. As of this writing, 12 final orders can be found in the repository.
For each OTC monograph title (e.g., nighttime sleep aid drug products), the repository provides an OTC Monograph ID (e.g., M002) and an Order ID (e.g., OTC000001) and an Order Title. Perhaps one day those numbers will be as familiar as references to the various parts of the CFR containing the monographs (maybe).
What is not found in the repository (as far as we can tell) is an easy way to access the rulemaking history for each order (the various tentative final monographs and amendments, and the advance notice of proposed rulemaking). The preambles to the rulemaking notices provide essential insights into FDA’s intent in adopting the original rules. The final administrative orders include the same citations to the relevant Federal Register notices that have always been found in the Code of Federal Regulations, but no links. We here at HPM hope that FDA will continue to maintain the webpage Status of OTC Rulemakings which contains easily accessed historical information and links. Even taking into consideration the webpage’s well-known shortcomings that resulted from a lack of funding for its upkeep over the years, it is a handy research tool. Better yet, the addition of links for the rulemaking/administrative order history for each administrative order in the repository would be quite welcome.
As described in our blog post here, in 2019 FDA issued a proposed rule for sunscreens under the OTC drug review as required implicitly by the Sunscreen Innovation Act (a deadline for a final rule, but not the requisite proposed rule was included in the SIA). By operation of its terms, the CARES Act, however, established a deemed final order for sunscreens, among other therapeutic categories as discussed above. The CARES Act also mandated that FDA issue a proposed order to amend and revise the deemed final order for sunscreens by September 27, 2021. FDA posted both the sunscreen deemed final order and the new proposed order before this deadline.
The provisions of the sunscreen deemed final order essentially maintain the status quo, including requirements related to active ingredients from the 1999 final monograph, which was stayed and did not go into effect, and the labeling and effectiveness requirements from the 2011 final labeling and testing rule codified at 21 CFR § 201.327. The deemed final order establishes the current monograph for OTC sunscreen products. Consequently, there is no longer a need for the guidance Enforcement Policy – OTC Sunscreen Drug Products Marketed Without an Approved Application and it has been withdrawn.
The sunscreen proposed order is substantively consistent with the 2019 proposed rule. Like the 2019 proposed rule, the new proposed order includes a maximum SPF value of 60+ and a requirement that all sunscreens with an SPF of 15 or higher meet the requirements for broad spectrum protection. As to active ingredients, again consistent with the 2019 proposed rule, the new proposed order proposes only zinc oxide and titanium oxide sunscreens as generally recognized as safe and effective (GRASE) and identifies the others as not GRASE either because of safety concerns (aminobenzoic acid and trolamine salicylate) or because of inadequate data to support safety (for the remaining ingredients).
A 45-day public comment period on the proposed order ends November 12, 2021. FDA will consider comments received on the proposed order in concert with those previously submitted for the 2019 proposed rule in developing a final administrative order. Interestingly, FDA has stated in FDA’s Questions and Answers and elsewhere that if at the close of the comments for the proposed order, available data do not resolve the outstanding questions about an ingredient, but FDA has received “satisfactory indication of timely and diligent progress on the necessary studies for a specific ingredient,” it would be prepared to initially defer issuance of a revised final order regarding the status of sunscreens containing that ingredient. If that sounds familiar, it’s because it is the approach FDA has taken with antiseptic monograph ingredients. For more information on the effects of these sunscreen orders, see FDA’s Questions and Answers webpage.
One of the commitments FDA made in the OMUFA goals letter was to publish by October 1st of each year a nonbinding list of monograph issues FDA intends to address in the coming three years. What issues would appear on the first list has been a subject of speculation since long before the CARES Act became law. We expected to see monographs related to drugs that have been the subject of drug safety communications from FDA such as benzocaine-containing products and codeine-containing cough medicines and also expected FDA would want to tackle pediatric dosing of acetaminophen. Others appearing on the list are more surprising. Here’s the list issued October 1, 2021 (in no particular order per FDA):
Planned Proposed Safety Orders
- Risks Associated with Codeine-Containing Cough Medicine
- Pediatric Acetaminophen Dosing
- Risks Associated with Propylhexedrine Abuse and Misuse
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and Oligohydramnios
- Oral Healthcare in Infants and Children (addressing benzocaine and phenol preparations)
- Serious Skin Reactions Associated with Acetaminophen
Also included on the list is a planned proposed order on the anticaries test method to address test methods.
FDA indicates in the forecast that it is not seeking additional data at this time in advance of issuing a proposed order and notes that each proposed order will specify a comment period during which data and comments can be submitted.