Timers Start Ticking At US FDA In A Month For An Even Dozen OTC Monograph Meeting Requests
Executive Summary
CDER Office of Nonprescription Drugs already accepts requests but won’t start responding until FY2023 begins on 1 October, also the start of FDA’s first year meeting with firms developing monograph changes and evaluating submitted proposals under deadlines included in program overhaul Congress authorized in 2020.
The first 12 requests the US Food and Drug Administration received for meetings to discuss proposals for OTC monograph changes during fiscal year 2023 will start something all the subsequent requests won’t – a clock ticking on the agency’s response.
Although already accepting requests, the Center for Drug Evaluation and Research’s Office of Nonprescription Drugs won’t start responding until FY2023 starts on 1 October.
The date also starts agency officials’ first year meeting with firms developing proposals for monograph changes and evaluating submitted proposals under deadlines included in a monograph program overhaul Congress authorized in March 2020.
Including deadlines for FDA responses and decisions on monograph meetings and proposals, identified as OTC monograph order requests (OMORs), was key in the pharma industry’s negotiations with the agency on reforming the program from lengthy and laborious notice-and-comment rulemaking to a more efficient administrative order process.
A CDER representative said 12 is the number of meeting requests that will start a clock on the agency’s response in the first year the OTC drugs office will conduct meetings, which is considered the third year of the program because the overhaul was authorized in 2020 in the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
“If more than 12 meeting requests are submitted in Year 3, the remainder will not be under timelines.”
The start of FY2023 “represents a milestone in the implementation of provisions of the CARES Act as the first of agreed upon timeline goals, for meeting requests, will be implemented,” the representative said in an email.
The timer on the OTC office’s response isn’t a simple measure. For the first 12 meeting requests received, the “FDA will meet 50% of the total of meeting management goal dates,” the representative said.
The deadlines for responses vary by the type of meeting requested: 14 days for Type X, necessary for an otherwise stalled OMOR development program to proceed or for important safety issue that needs immediate action, and for Type Y meetings for overall data recommendations and pre-OMOR submission. For Type Z meetings, “any meeting that is not a Type X or Type Y meeting,” the timeline for a response is 21 days. (Also see "'Milestone' Discussions With US FDA On OTC Monograph Proposals Limited To One Meeting" - HBW Insight, 23 Feb, 2022.)
The management goal dates for all meetings are for response, scheduling and minutes; Type Y meeting requests also create preliminary response dates for the agency.
OTC Office’s Capacity Determines Response Times
FDA officials made clear in the monograph reform negotiations, and detailed in a letter to Congress stating its performance goals after lawmakers authorized overhauling the program, that the CDER OTC drugs office would have capacity for only so many meetings and evaluations.
“What they've told us, we're in the negotiation phase on the goals letter. Well before passing, we were trying to estimate how many meetings do we think people would ask for. It might be 10, it might be 50, it's really hard to tell,” said David Spangler, senior vice president for regulatory and government relations at the Consumer Healthcare Products Association.
FDA officials explained to Spangler and representatives of other industry stakeholder groups during negotiations on monograph reform that the pace of the agency’s responses to meeting requests would be determined by factors including the number of full-time equivalent staff positions available for the work and how soon people added to those posts could be trained.
“Based on all those things, they said, ‘This is how much capacity we have. Therefore, if we get flooded with meeting requests … we're not saying we're not going to try and meet timelines, but we're not going to be measured against that by Congress’,” Spangler told HBW Insight.
Monograph ‘Dashboard’ Also Going Live
The start of FY2023 also likely will lift a curtain on an information technology platform offering a view to the agency’s OTC monograph work. (Also see "OTC Monograph User Fee Goals Document Beats Authorization To Finish Line" - HBW Insight, 27 Jul, 2017.)
The “public facing IT dashboard” should go live when the OTC drugs office post its second monograph forecast annual posting, a non-binding list of safety orders planned for proposing or also being considered the office anticipates posting by October 1.
The dashboard will be accessible to the public as well as the industry and will track progress on proposals and on the agency's reviews.
Planned proposed safety orders in the first annual forecast, posted in October 2021, included addressing the generally regarded as safe and effective status of codeine, including phosphate and sulfate forms, as antitussive active ingredients and dosage strengths of oral, single-ingredient pediatric acetaminophen products. (Also see "US FDA Meets Initial Deadlines In OTC Monograph Overhaul While It's Rebuilding The Program" - HBW Insight, 5 Oct, 2021.)
HBW Insight will report additional articles over the next week about the pending launch of the FDA's overhauled OTC monograph program.