Monograph Reform Legislation In Play As FDA, OTC Industry Get Real On Changes
Executive Summary
FDA and CHPA preparing for changes to monograph procedures the agency and industry negotiated, including a user fee program, and are included in legislation passed by House and introduced in Senate. But neither the agency nor the trade group expects to be entirely ready before the legislation passes, whenever that might be.
Overhauling the US Food and Drug Administration's OTC drug monograph program depends on Congress passing legislation, something agency officials and industry stakeholders are confident will come but aren't predicting when.
The FDA and the Consumer Healthcare Products Association are preparing for changes to monograph procedures that the agency and industry stakeholders negotiated, including a user fee program, and that are included in legislation passed by the House and introduced in the Senate. But neither the agency nor the trade group expects to be entirely ready before the legislation passes, whenever that might be.
"We can't obviously get there until the legislation is final. … We're trying to build infrastructure and since this is so very new, it's going take us quite a while to do so," said Theresa Michele, director of the FDA Office of Nonprescription Drug Products, on May 22 at CHPA's annual regulations and science conference.
"We don’t know when Congress will pass it but we hope to be ready when they do," Michele said during the closing session of the two-day conference in Rockville, Md. "I don’t want anyone to think that on day one, everything will be smooth sailing and we'll be perfectly ready," she added.
"There's only so much we can do until this legislation passes," said Barbara Kochanowski, CHPA's senior vice president, regulatory and scientific affairs, during her same-day remarks on OTC monograph reform.
But in late 2018, CHPA asked, "If it passed tomorrow, would we have everything that we needed?" Kochanowski said.
The trade group launched a regulation tab on its web site with information on the legislation and changes it would impose, including user fees to help pay for the FDA's work on monographs, essentially menus of ingredients and formulations that can be used in drugs for certain indications, and is updating the page when additional information is available. Additionally, a question and answer page it opened is generating numerous queries from members about how monograph reform will work.
"I have a feeling once this passes we're going to start hearing from people we might not know well or maybe are just finding out that this has come to pass and they want to send us feedback," Kochanowski added.
'Goals Document' Offers Guidance
One thing ONDP won't do until after Congress would pass monograph reform legislation is guidance on compliance with the changed program, which is the process by which the majority of nonprescription drugs are approved for marketing in the US.
In lieu of guidance, Michele suggests referencing a goals document ONDP published about the planned overhauled program. "It represents the tradeoff that we came to with the industry. Obviously, we would like to everything on day one, but that's not possible. That's a lot of infrastructure that needs to be built in order for us to do those things," he said.
ONDP prepared and published the goals document in 2017 stating proposed guidelines for submitting monograph change proposals, for its application and review deadlines, for adding staff to the agency's monograph review team and for other components of the process and its costs track with discussion drafts of legislation authored by early sponsors of making the changes, Sens. Johnny Isakson, R-GA, and Bob Casey, D-PA. (Also see "OTC Monograph User Fee Goals Document Beats Authorization To Finish Line" - Pink Sheet, 27 Jul, 2017.)
It also includes a schedule for developing and launching an online platform accessible to the industry and the public that will track progress on proposals and on the agency's reviews; a plan for launching an IT portal specifically for receiving monograph submissions, or "OTC Monograph Order Requests"; $22m to $34m in user fees primarily from facility registrations; and a two-tier review system.
The FDA published the document as its push for authorizing legislation, with the industry's backing, initially gained steam. However, the first expected chance for the bill's passage – as part of 2017 legislation re-authorizing the agency's prescription drug user fee programs – didn't materialize. (Also see "Waiting For Congress: Reforming, Paying For FDA OTC Monograph Program" - HBW Insight, 24 Aug, 2017.) And although the House has passed its bill three times with bipartisan support, including most recently in January as part of legislation on reauthorizing federal hazards preparedness and response programs, the proposal has not gained traction in the Senate outside of the Health, Education, Labor and Pensions Committee, which passed it with one vote against in 2018. (Also see "House Maintains Momentum For OTC Monograph Reform, Senate Regard TBD" - HBW Insight, 9 Jan, 2019.)
'More Regulation' Good For Industry
Kochanowski pointed out that in addition to bipartisan backing in Congress, monograph reform has support from numerous medical, public health and consumer advocacy groups.
"This is sort of our last hurdle … Our view is that we simply have to find the right time and the right vehicle and we believe that this will pass," she said.
CHPA President and CEO Scott Melville says "there's no issue that's more important, no priority bigger" currently for the trade group than monograph reform. That's true even though the industry's regulatory burden would grow and firms would incur user fees under the legislation.
"It's not often that a regulated industry is asking for more regulation, supporting legislation that will give its regulatory authority more authority and also, on top of that, pay millions of dollars of fees to the regulatory agency," Melville said, adding that "the decision to support this legislation was not made lightly."
OTC drug manufacturers and marketers, he said, will benefit from paying for FDA's work to make the monograph program work more efficiently. The FDA and industry need a regulatory framework they can depend on, one "that enhances the trust of consumers who take our members products each and every day," Melville said.
"Really, if we're being honest, the current regulatory framework is not meeting those needs," he added.
User fees weren't an easy sell to CHPA members and weren't in the trade group's plans when it began negotiating monograph reform details with FDA. (Also see "CDER Asked To Shed More Light On Potential Monograph User Fees" - HBW Insight, 16 Jun, 2016.)
"We didn't go into OTC reform with the idea of paying user fees," Kochanowski said..
"This may have been naïve. … but the more we understood about what it takes at FDA to actually make changes, implement changes, to develop new IT systems, hire people – there were only a few 10s of people working on the OTC monograph system. That's true even today. Our industry deserves more resources, we deserve more support and especially if we want to innovate and move forward."
FDA's monograph program launched in 1972 to allow OTC ingredients generally regarded as safe and effective for their intended uses to remain available and as a process for proposing additions of more ingredients or indications. However, any addition or other change, no matter how small or how urgently needed, requires a notice-and-comment rulemaking, a longer and slower process than FDA's procedures for reviewing and deciding whether to approve new prescription drugs, or nonprescription drugs containing ingredients previously available Rx-only. The program has been stalled for much of its nearly 50 years and FDA and industry stakeholders identified reforming the program as a nonprescription sector priority well before they began negotiations on a proposal.
Spurring Innovation, Specifying Ingredients' Status
Spurring innovation – adding to the ingredients and indications allowed for OTC drugs – is a key driver for monograph reform and FDA agreed with the industry to include in the proposal an incentive of market exclusivity for some approved changes. (Also see "OTC Monograph Legislation Clears Another Hurdle Despite Exclusivity Concerns" - HBW Insight, 11 May, 2018.)
Still, accelerating the monograph process clearly is the primary impetus.
"Currently … it takes many years to make a change to a monograph, and the goal under monograph reform is to shorten that timeframe substantially, while still maintaining public comment between proposed and final orders, and maintaining FDA’s standards for safety and efficacy," goals document states.
Kochanowski said while the program initially worked with a rulemaking process, around 25% of the OTC monographs are not finalized and additional data are needed for ingredients proposed for formulations and indications in those.
"It will be really nice to get that done and maybe focus on new ingredients and new things we can add to monographs. That speaks more to innovation," Kochanowski said.
"It was becoming tiresome that we could not do things like safety labeling changes that we had to do a lot on a voluntary basis … It's much better to have clear system and have a system that works and not rely on voluntary actions," she said.
Ingredients in non-final monographs aren't the only types on the minds of manufacturers and marketers, Michele noted. Whether any ingredient currently used in OTC drugs available in the US is included in a monograph also is a concern.
"We're still very early in the process in terms of an ingredient list. That's something we've been working on for a long time," said the ONDP director, responding to a question about when firms will know about ingredients they use.
"What we have been doing is going through, in a very, very detailed fashion, all the old monographs that are out there to see what was included, what was not included what is the status of each ingredient because we recognize that under monograph reform people are going to be confused once this legislation passes as to what's the actual status of their ingredients," said Michele, who also spoke on the FDA's novel switch initiative during the conference (see sidebar).
"We hope to help that along as much as we can and also to make sure that we have as much information out there through the public-facing portal as we can as early as we can in the process."