Second Wind For OTC Monograph User Fee Legislation In House Hearing
This article was originally published in The Rose Sheet
Executive Summary
House Health Subcommittee's “Modernizing FDA’s Regulation of Over-the-Counter Drugs” hearing Sept. 13 will "examine draft legislation to establish" a user fee program to support FDA's work on evaluating proposals for additions or changes to its nonprescription drug monographs.
Chances this year for legislation on reforming FDA's OTC drug monograph program and creating a user fee to support it could be revived as a House subcommittee expects to have a draft bill ready for a hearing on Sept. 13.
The Energy and Commerce Committee's Health Subcommittee's “Modernizing FDA’s Regulation of Over-the-Counter Drugs” hearing will "examine draft legislation to establish" a user fee program to support FDA's work on evaluating proposals for additions or changes to its nonprescription drug monographs.
Personal care and cosmetic product manufacturers should take note that the legislation might gain momentum, says regulatory consultant David Steinberg (see sidebar).
Although the subcommittee referred only to user fees, a proposal developed by FDA and drug industry stakeholders included provisions for changing the program, primarily by setting timelines for completing reviews and proposing orders to add ingredients or indications to a monograph. That FDA/industry proposal served as a blueprint for earlier discussion drafts circulated by Sens. Johnny Isakson, R-GA, and Bob Casey, D-GA. (Also see "OTC Monograph User Fees Still On The Table, But Not In Legislation" - Pink Sheet, 11 Aug, 2017.)
The subcommittee includes a member from both parties known to support changing FDA's monograph program, Rep. Brett Guthrie, R-KY, who is vice chairman, and Diana DeGette, D-CO. Their interest could be key to moving a potential bill out of the subcommittee to Energy and Commerce, where other members could join the push. Reps. Robert Lata, R-OH, and Gene Green, D-TX, who are members of the full committee, also have shown support for making changes and creating a user fee program.
Additionally, committee Chairman Michael Burgess, R-TX, acknowledges FDA's position that the monograph process is irreparably stalled. "The process of bringing a new OTC monograph drug product to market is outdated and in need of reform,” said Burgess in the committee's release.
A draft of the legislation was not made available by the subcommittee, but staff in the Energy and Commerce Democratic office said they expect a draft will be ready for the hearing.
The Consumer Healthcare Products Association industry group said the discussion draft likely will be an updated version of drafts Isakson and Casey shared as they pushed to include monograph reform and user fee provisions in legislation that renewed FDA's existing pharmaceutical and medical device user fee programs, the FDA Reauthorization Act.
Energy and Commerce Chairman Michael Burgess: "The process of bringing a new OTC monograph drug product to market is outdated and in need of reform.”
Congress passed FDARA without the monograph provisions, dashing most expectations for legislation during 2017 to reform FDA's stalled OTC drug evaluation and approval process and to create in tandem a user fee program. (Also see "No Authorization For OTC Monograph Reform And User Fees, But Webinar Goes On" - HBW Insight, 18 Aug, 2017.)
The agency in 1972, following congressional authorization, launched its monograph system for allowing OTC ingredients generally regarded as safe and effective for their intended uses to remain available and as a process for additions of more ingredients or indications, with changes subject to approval in public rulemakings. Monographs essentially are menus of ingredients and formulations that can be used in nonprescription drugs for certain indications.
While the system of proposals, evaluations and decisions operated efficiently in the early years of the program, the opening of rulemakings to wider public exposure and input made any change a lengthy and difficult process. Additionally, budget problems for FDA's OTC drug programs made the monograph system a low priority for the agency.
The proposal FDA and stakeholders have provided to Congress takes monograph decisions out of the rulemaking arena, giving the agency authority to use orders instead, and also sets timelines for the evaluation process for each proposal. The industry, despite initial resistance from some parties, also agreed to FDA's recommendations that a user fee program is necessary to pay for its monograph work. (Also see "OTC Monograph User Fees: FDA-Industry Talks Move From Basics To Details" - Pink Sheet, 2 Aug, 2016.)
Although FDA did not expect to implement the changes it proposed after Congress passed FDARA without those provisions, the agency in August conducted a webinar on how the changes would have affected drug manufacturers. Agency officials made clear during the webinar that without authorization from Congress, there will be no changes to the program or start of user fees to pay for it. (Also see "Waiting For Congress: Reforming, Paying For FDA OTC Monograph Program" - HBW Insight, 24 Aug, 2017.)
From the editors of The Tan Sheet. Our dietary supplement industry coverage now is published in The Rose Sheet, with articles emailed to readers daily and available on this page of The Rose Sheet website.