OTC Monograph Bill Has Energy And Commerce Date, CDER Director's Hope
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
US House is catching up with Senate on OTC monograph legislation, with a committee markup expected in the next few days.
A House committee is expected to vote May 9 on legislation to overhaul US FDA's OTC monograph process, the latest congressional action that helps the agency's drug center chief to remain hopeful lawmakers will pass the changes this year.
"We have to be able to reform the monograph. We hope to be able to reform the monograph process and modernize that whole process," Center for Drug Evaluation and Research Director Janet Woodcock said May 3 at the Food Drug Law Institute annual conference in Washington.
"It's one of the final places in CDER where we really do not have a modern program and our hands are tied in many ways. We're very pleased with what Congress is doing," Woodcock added during her presentation on the center's current priorities.
During a brief interview following her remarks, Woodcock said she'd describe her view on passage this year of OTC monograph legislation as "hopeful" more than "confident."
She also noted, though, that changes to the monograph progress, even if not passed this year, are likely to come sooner than potential changes to FDA's rules for evaluating new drug applications for Rx-to-OTC switches.
Any changes to FDA rules on OTC switch proposals, such as deeming instructions or other information about a drug's indication and usage accessed online as part of a product's Drug Facts label, would come from an agency rulemaking. "That will take much longer," Woodcock said.
FDA is considering other input from stakeholders received since it opened an initiative in 2012 to facilitate making more Rx-only ingredients available nonprescription by making the OTC switch. The goal is to make the process more flexible to accommodate "novel" switches. Such switches likely provide consumer information beyond the text printed on a product's packaging and DFL. (Also see "FDA's OTC Naloxone Study Is A Starting Point For Other Switches, Not A Roadmap" - Pink Sheet, 16 May, 2017.)
Monograph Bill In Energy And Commerce
During a May 4 FDLI session on the OTC monograph system, Consumer Healthcare Products Association President Scott Melville said the House Energy and Commerce Committee is expected to vote on a monograph overhaul bill, H.R. 5333 on May 9.
The committee's May 9 session is scheduled as a hearing on wholesale drug distribution and diversion in the US opioid abuse epidemic. (Also see "Opioid Legislation Would Require US FDA Guidance On Non-Opioid Pain Medication Development" - Pink Sheet, 24 Apr, 2018.) But Melville said the panel is also expected to mark up H.R. 5333 and forward it to the full House.
Industry groups have been eagerly awaiting progress on H.R. 5333, sponsored by Rep. Robert Latta, R-OH. A draft bill had been considered in January. (Also see "Shorter Exclusivity In House OTC Monograph Bill Could Gain Industry Acceptance To Speed Passage" - Pink Sheet, 22 Mar, 2018.) The Senate Health, Education, Labor and Pensions Committee has already cleared Sens. Bob Casey D-PA and Johnny Isakson's, R-GA, monograph measure, S. 2315. (Also see "Senate OTC Monograph Reform Bill Clears HELP For Floor Vote" - Pink Sheet, 24 Apr, 2018.)
Currently, formal rulemaking is required to add ingredients to an OTC monograph or add or change an indication. Both the House and Senate bills would replaced this an administrative order process empowering FDA to evaluate and decide monograph proposals much like its does new drug applications for Rx drugs and OTC switches. The bills also would authorize a user fee program to pay for FDA’s monograph work, based on per-proposal fees and annual facility registrations. In return, FDA would have deadlines for action in each step of evaluating proposals.
The only major difference between the House and Senate bills is that the House offers an 18-month exclusivity period for some innovative consumer products introduced under the proposed new monograph system, while the Senate bill proposes a two-year period.
FDA Would Hire 20 Monograph Staff Per Year For Five Years
Like Woodcock, Melville and other speakers during the OTC monograph session said they are optimistic Congress will pass the legislation. They also discussed changes at FDA and in the industry that could follow the bill's passage.
“There is broad agreement on [OTC monograph reform] and a high degree of confidence it gets done this year, and not impossible this summer,” said Elizabeth Jungman, Pew Charitable Trusts Public Programs director. Jungman said bipartisan support for S. 2315 was evident "with no debate at all” on the bill during the Senate HELP markup. Additionally, Democrat and Republican lawmakers alike are looking for some legislation that will pass. "We’re in a Congress that needs some wins," she commented.
David Spangler, CHPA senior vice president for policy, pointed out CDER stated in a procedures and performance goals document for the monograph user fees program that it will need to hire about 20 additional full-time equivalent staff each year in the first five years of the reform program.
In addition to timelines and submission standards, CDER's goals document includes a schedule for developing and launching an information technology platform accessible to the industry and the public that will track progress on proposals and on the agency's reviews. The center also includes in the manual a plan for launching an IT portal specifically for receiving monograph submissions in 2022. (Also see "OTC Monograph User Fee Goals Document Beats Authorization To Finish Line" - Pink Sheet, 27 Jul, 2017.)
Spangler noted that the goals document includes $22m to $34m in annual user fees from OTC manufacturers – primarily from facility registrations. (Also see "OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft" - Pink Sheet, 19 May, 2017.)
Asked how much facilities will pay, Spangler noted FDA has projected 2,000 facilities in the US are making OTC drug monograph products and the registration fee estimate is $15,000.
From the editors of the Tan Sheet.