OTC Monograph 'Disruption' Could Ride Along With PDUFA Reauthorization – CHPA Exec

Changing the monograph process is an area "where disruption can be positive," CEO Scott Melville says at CHPA conference. Best chance for monograph reform could be tying it to user fee reauthorization, but that could be a lengthy process.

Leaders in the consumer products arena are eying the Rx user fee reauthorization as a promising vehicle to achieve their long-held goal of revamping the OTC monograph process.

A Consumer Healthcare Products Association working group has brought stakeholders together to find many areas of agreement on monograph changes. If remaining points of contention could be worked out, "there's a good chance OTC monograph reform could soon be debated in Congress, potentially as part of next year's prescription drug user fee reauthorization," CHPA President and CEO Scott Melville said.

The association has just concluded its executive conference in Aventura, Fla., where the theme was disruptive forces in the industry and marketplace. Both Melville and board Chairman Patrick Lockwood-Taylor, a Procter & Gamble Co. executive, emphasized making the monograph process more efficient for adding ingredients and formulations that are available OTC.

Changing the monograph process would be "one example of where disruption can be positive," Melville said during a March 15 conference session.

"This is almost as disruptive as the introduction of the monograph itself. Any reforms need to create value for consumers, the FDA and the manufacturers of medicines within the system," said Lockwood-Taylor, P&G's VP for personal health care North America and digestive wellness design.

Monograph products – OTCs approved without new drug applications – account for the majority of OTC drugs currently available in the US.

FDA in February 2014 opened a docket for comments on overhauling the OTC monograph process to be “more agile and responsive” and conducted a public hearing in March of that year (Also see "FDA Floats OTC Monograph Overhaul To Be “More Agile And Responsive”" - Pink Sheet, 24 Feb, 2014.).

CDER's Monograph Questions

In its monograph process review, FDA’s Center for Drug Evaluation and Research asked for comments on the strengths and weaknesses of the OTC Drug Review and possible modifications or alternatives to the program. CDER also proposed several potential changes and sought input on:

* expanding the process for allowing deviations from drug formulations approved through new drug applications

* issuing monographs by administrative order

* identifying a streamlined process that would allow prompt resolution of existing tentative final monographs

* issuing regulations to require product specific information

* expanding the use of guidances.

However, two years later the agency has not proposed any changes and no ingredients have been added to any monograph. And although Congress passed the Sunscreen Innovation Act in late 2014 to improve the chances for additional OTC sunscreen ingredients to be available, FDA rejected all of the pending time and extent proposals for new sunscreen ingredients (Also see "Sunscreen Innovation Act Illuminates ‘Good Things’ For OTC Monograph Reform" - Pink Sheet, 25 May, 2015.).

"For two years now I've spoken about how the monograph system is not working as it once did. In fact, the administrative rulemaking process upon which it is based has essentially rusted shut," Melville said.

For any change, from a new delivery format for a monograph ingredient or to change a product label, "you'd better get ready for a long haul, or be willing to take on regulatory uncertainty and risk," he added.

Paying For Reform

In addition to submitting comments, CHPA in 2015 formed a working group to make recommendations to FDA on changing the monograph process.

"We've had literally dozens of meetings with the FDA and leaders on Capitol Hill to frame the issues and seek a consensus approach," Melville said.

Lockwood-Taylor said "CHPA has made substantial progress on aligning with FDA around how to modernize the monograph system."

"We can push for a simplified, more transparent rule making process, a more effective way to address safety issues, enable more innovation to improve consumer value, reduce the time and cost burden for new OTC products and an improved process for consultation," he said.

Melville added "we've made considerable progress and have winnowed the points of contention to just a few."

"If we can work those out, there's a good chance OTC monograph reform could soon be debated in Congress, potentially as part of next year's prescription drug user fee reauthorization, or PDUFA" (Also see "PDUFA Negotiations End, Approval Process Ongoing" - Pink Sheet, 26 Feb, 2016.).

"I think there is an opportunity that if the policy could be agreed to between the Senate, House, FDA and industry, potentially a separate bill would be introduced," he said in an interview. The PDUFA reauthorization "would be a logical vehicle" to pass the changes.

Paying for FDA's work created in the monograph reform, though, likely will be a contentious element of the potential legislation.

While FDA officials long have said the agency does not have sufficient resources to fund the work needed to review proposals for monograph changes, the OTC industry likely would back creating a user fee program, similar to PDUFA, to support the work.

However, creating additional costs for industries through user fees or other methods typically is not supported widely in Congress. User fee programs to support the agency's food safety oversight were created in the Food Safety Modernization Act, but Congress has passed on other fee programs FDA has recommended before and since passing that legislation.

"Where fees have been successful in the past are situations where the industry and the FDSA can come to an agreement that, from the industry's perspective, there's added value being received above and beyond what the industry thinks it can get from appropriated funds and they're willing to pay for it. From our perspective, we haven't come to that conclusion yet," Melville said.

"We're a long way from being anywhere close to that. We're first trying to access what the policy changes might look like," he added.

[Look for additional reporting from the Consumer Healthcare Product Association's 2016 executive conference in "The Tan Sheet."]