Clock Ticks On Adding OTC Monograph Reform To FDA User Fees Bill

With Congress leaving Washington for Independence Day week and much of August, few days remain to consider adding to each chamber's reauthorization legislation language from Sens. Isakson and Casey's discussion draft for US OTC monograph reform and a user fee program to support FDA's work.

Time is running short and competing issues are stacking high for adding OTC monograph reform and user fees to legislation reauthorizing FDA's existing user fee programs for another five years.

With Congress leaving Washington during the week of Independence Day and for much of August, few days remain for House and Senate committees to consider adding to language from Sens. Johnny Isakson, R-GA, and Ben Casey's, D-PA, OTC discussion draft to the pending reauthorization legislation – H.R. 2340 and S. 934.

Failure to reauthorize the user fee programs agreements by late July would prompt FDA to send layoff notices to more than 5,000 employees to notify them that they may lose their jobs when the federal fiscal year ends Sept. 30.

The Consumer Healthcare Products Association, which negotiated with FDA on terms of the monograph proposal included in the draft, is joined by medical and advocacy groups the American Academy of Pediatrics, Society for Maternal-Fetal Medicine, American Public Health Association, March of Dimes, Pew Charitable Trusts and National Association of County and City Health Officials in urging members of Congress to include the changes in the user fee reauthorization legislation.

The groups continued urging passage in their latest letter, dated June 14, to Isakson, Casey and Senate Health, Education Labor and Pensions Committee Chairman Lamar Alexander, R-TN, and ranking member Patty Murray, D-WA. They say "monograph reform can and should be included within the Food and Drug Administration Reauthorization Act (FDARA) of 2017," and FDA, the pharma industry "and public health stakeholders are in clear consensus that OTC drug regulation reform is long overdue and should be a top priority for this Congress."

However, FDA's OTC monograph problems likely are not a priority for Congress currently. An overhaul of the Affordable Act – either repeal and replace or enacting changes – is the health care-related topic dominating Congress members' attention. Imposing drug-pricing standards has emerged as one contentious topic in discussions on legislation targeting changing or repealing the ACA. (Also see "Drug Pricing Hearing In Senate Postponed, Handing Innovators Another Victory" - Pink Sheet, 29 Jun, 2017.)

When the House and Senate resume meeting July 10, additional hearings and ongoing investigations into Russian hacking into US elections and on potential illegal collaboration with Russian officials and businesses by people associated with President Trump's campaign along with work on developing and approving FY 2018 appropriations for FDA and other federal agencies will dominate members' time.

Doing anything more than passing FDARA only to continue FDA's existing user fees programs could be too much to expect, says Kurt Karst, a food and drug lawyer following FDARA discussions.

"At some point it will come down to, just get it out," said Karst, a director at Hyman, Phelps & McNamara P.C. in Washington.

Backing from CHPA and its allies is crucial to any chance for adding the monograph reform language to FDARA, and Congress is capable of surprises.

"I certainly think [CHPA's lobbying] helps. But the timing doesn't help," Karst added in an interview.

CHPA is keeping its eye on the goal. "We are optimistic that OTC Monograph reform will move forward along with the FDA Reauthorization Act,” the group told the Pink Sheet.

Pew, the lead in contact with Congress among the groups backing monograph reform, points out making the changes has bipartisan support. "We have confidence that Congress will act before the end of 2017 to address outdated and inefficient OTC regulation under the current monograph system,” said Kirsten Moore, PEW's health care products project director.

Isakson and Casey propose that manufacturers have two tracks for proposing changes to OTC products marketed under the monograph system: one for adding new medical conditions treated by the ingredients, which would be eligible for exclusivity when clinical trials are required, and another for most other types of changes. The senators in early May released an initial discussion draft and in early June distributed another version that had been cleared of notes and questions. (Also see "OTC Monograph Reform Proposal Offers Two-Tier Approach" - HBW Insight, 30 May, 2017.)

Similar to the Sunscreen Innovation Act Congress passed in 2015 to encourage adding new ingredients to the OTC sunscreen monograph, the discussion draft proposes deadlines for FDA reviews for the other monograph categories.

Total annual user fees of $22m to $34m from OTC manufacturers – primarily from facility registrations – are among the draft's proposals. Fees would also be raised when companies request changes via the monograph system. (Also see "OTC Monograph User Fees Up To $34M Floated In Senate Discussion Draft" - HBW Insight, 30 May, 2017.)

FDA launched the monograph program, following congressional authorization, in 1972 as a system for allowing OTC ingredients generally recognized as safe and effective for their intended uses to remain available and for offering drug firms and other parties, including the agency, a process for proposing additions of more ingredients or indications. However, the program has been stalled for much of its 45 years and FDA and industry stakeholders identified reforming the program as a nonprescription sector priority well before they began negotiations on a proposal in June 2016. (Also see "'Real Challenge' To Improve OTC Monograph Program Without User Fees – FDA" - Pink Sheet, 13 Jun, 2016.)

From the editors of The Tan Sheet