All Roads For OTC Policy Improvements Lead To User Fees, FDA Suggests

During update on user fee discussions with industry to support FDA's OTC monograph program work, CDER officials say "industry and public would suffer" absent new fees.

All roads lead to user fees as far as improving FDA's process for adding ingredients or indications to OTC drug monographs, Center for Drug Evaluation and Research officials' comments to industry stakeholders suggest.

"There's simply not enough appropriated money to go around for all of the things the agency has to do," said Donal Parks, director of CDER's Division of User Fee Management and Budget Formulation, during a Sept. 6 FDA webinar to provide an update on FDA-industry discussions about potential monograph program user fees.

Asked for FDA's outlook on the monograph process if a user fee program is not established, Parks was blunt: "The industry and the public would suffer."

"The basic course of action is we keep doing what we're doing with what we have," he said. "There's a lot of work to be done but not a lot of resources for it."

Some industry stakeholders have been wary of endorsing the fees before there are more details on how the monograph process would be improved. Nonetheless, the OTC industry appears to take it to heart that a new source of funding is necessary, said Karen Mahoney, deputy director of CDER's Division of Nonprescription Drug Products. Drug firms' opportunities to introduce new nonprescription products, other than through Rx-to-OTC switches, are inhibited by limited FDA funding for the monograph process.

"FDA and the industry have known for a long time that the OTC monograph review is significantly under-resourced, but over the years the industry has come to realize that this lack of resources isn't just an FDA issue. It's also affecting the industry's ability to do what it needs to do," Mahoney said during the webinar.

"Industry is very interested in innovation. In order or the agency to be able to evaluate innovations, additional resources are needed," she added.

Mahoney and Park's comments were consistent with previous agency statements about a lack of funding available for OTC programs since well before floating the idea of a monograph user fee in a Federal Register notice in May. (Also see "FDA May Well Need OTC Drug Funding, But Stakeholders Want Program Specifics" - HBW Insight, 24 Jun, 2016.) But they offered few details from discussions with industry to establish a fee program that began in July.

"Over the years the industry has come to realize that this lack of resources isn't just an FDA issue. It's also affecting the industry's ability to do what it needs to do." – Karen Mahoney, deputy director, FDA Division of Nonprescription Drug Products

FDA's existing resources include $8.2m for OTC programs in the Center for Drug Evaluation and Research's fiscal 2016 budget, 18 full-time equivalents in CDER working only on nonprescription drug issues and 12 other FTEs with responsibilities that touch on OTCs.

Those levels of resources appear even more limited when considering FDA's overall mission, with priorities often determined by considerations other than innovation. "Currently FDA must focus its resources on public health emergencies and external mandates," Mahoney said.

She suggested policymakers would see a "compelling case" for user fees to improve the monograph process, perceiving that the availability of more consumer health care products is a public health benefit.

The House Energy & Commerce Committee Democratic chief of staff noted recently that the committee considers FDA user fees generally favorably, largely they provide more money for programs without drawing on the federal budget. (Also see "'Real Appetite' For User Fees Among Energy & Commerce Democrats" - HBW Insight, 8 Jul, 2016.)

Should the OTC drug industry and FDA agree on the framework for a potential fee program, their agreement would be recommended as the basis for legislative enactment. The OTC measure could be tied to the reauthorization of the Prescription Drug User Fee Act in 2017 or the Animal Drug User Fee Act in 2018 . (Also see "OTC Monograph User Fees: FDA-Industry Talks Move From Basics To Details" - Pink Sheet, 2 Aug, 2016.)

'Consumed By' Sunscreen, Antiseptic Monographs

FDA opened a separate comment document in 2014 for input on how to improve the monograph process. (Also see "“No End In Sight” For Completing OTC Monographs – CDER Director Woodcock" - HBW Insight, 31 Mar, 2014.) But there too, the agency emphasized that a dearth of monograph actions over the past 10 years made outside of targeted legislation or a consent decree following litigation reflects a lack of resources for the agency as much it shows problems with the process.

Legislation set deadlines for FDA to review potentially adding ingredients to the sunscreen monograph. (Also see "Sunscreen TEA Advocates Want Help Scaling FDA’s ‘High Bar’ For OTC Monographs" - Pink Sheet, 6 Feb, 2015.) And a 2013 consent decree eventually led to the Sept. 2 final rule establishing 19 active ingredients as not generally recognized as safe and effective for use in consumer antiseptic wash products. (Also see "FDA Rule Marks Consumer Antibac Soaps A Possible Endangered Species" - Pink Sheet, 2 Sep, 2016.)

But Mahoney pointed out that said "we have dozens if not scores of" other monograph changes or additions to consider. "Being consumed by just two or three makes it very difficult for us to attend to our overall mission," she said.

And the monograph mission is made difficult by the program's regulatory framework that requires formal rulemaking for any change, a point CDER Director Janet Woodcock has made. (Also see "Rulemaking Process Flawed, But Making Monograph Rules Still Needs Funding" - Pink Sheet, 20 Jun, 2016.)

"That has to do with the extreme difficulty with the current rulemaking process. It has been very difficult to go through the rulemaking process to add new ingredients," Mahoney agreed.

In addition to a potential OTC monograph user fee, personal care and cosmetic product firms could be subject to a separate user fee under Senate legislation that also would require facilities registration, product and ingredient statements and submitting serious adverse event reports to FDA. (Also see "PCPC: Cosmetic Legislation A Long Shot In 2016, But Objectives Are Clear" - HBW Insight, 2 Mar, 2016.)

From the editors of the Tan Sheet.