OTC Drug User Fee Meeting Lacks Specifics, But Idea Supported
A 6/10 FDA public meeting on the potential development of a user fee program for over-the-counter (OTC) monograph drugs drew criticism from some stakeholders who called for the agency to be more transparent and upfront on what kind of program it is seeking. FDA presenters provided no proposals or ideas as to how such a program could be structured, which seemed odd considering that there are already user fee programs for prescription drugs, generic drugs, biologics and medical devices. Despite the lack of FDA input, most stakeholders supported creating a user fee program, and they offered a number of suggestions on how it could be structured.
CDER Division of Non-prescription Drugs deputy director Karen Mahoney told the meeting that OTC drug review remains one of the largest and most complex FDA programs, with over 800 active ingredients for more than 1,400 different uses. CDER Division of User Fee Management and Budget Formulation director Donal Parks said that between 2014 to 2016, the agency has dedicated less than 30 full-time employees per year to the OTC monograph program, which oversees more than 200,000 products, and the FDA appropriations process has substantially cut funding for the program.
University of Pittsburgh retired professor and former OTC Drug Products Advisory Committee chairman Randy Juhl scoffed at FDA’s lack of transparency, saying he did not understand its approach. He said the notice for the meeting might has well have been written like this: “We are going to ask for money, and we are not going to tell you what we are going to do with it, and we are not going to tell you how much we want, and we don’t know when we will be done.”
Despite any specifics from FDA, there was no shortage of public comments on how such a program could be structured. He urged FDA to provide more information to inspire confidence that this can be done. “Regulatory processes always move better when the public and other stakeholders are informed, engaged, supportive and confident that new money will be invested in processes that bring measurable success,” he told the agency. “User fees will require a transparent process that tells everyone what they are being asked to buy, how much it will cost and what public health achievements will be realized and when. A discussion of OTC user fees seems premature without that information. I'm really supportive and I know it’s needed, but more information is needed.”
Consumer Healthcare Products Association vice president Barbara Kochanowski took her opportunity at the podium to call for reforming the OTC monograph system. “While the monograph system has served our nation well, it has become cumbersome and outdated and needs to be modernized,” she said. “The rulemaking process upon which it is based is stalled, a bigger issue than just for the monograph process. FDA needs the ability to protect the public health by completing unfinished monographs and making labeling updates in a timely fashion. In addition, industry desires the ability to innovate and provide consumers with modern technology to support safety, efficacy, and compliance.”
Kochanowski said that a user fee program for nonprescription medicines will need thorough discussion and study. “Unlike other drugs subject to user fees, nonprescription drugs under the monograph system are not subject to FDA approval prior to marketing,” she said. “Many of these ingredients have been marketed for more than 40 years, with a long history of safe use. There is no backlog of applications. Therefore, we must define value differently than industries subject to FDA approval prior to marketing... Fees for nonprescription medicines under the monograph system could be a disincentive for innovation, or they could incentivize innovation, depending on how they are applied. For example, today, very few manufacturers are filing New Drug Applications and paying the PDUFA fee to innovate with monograph ingredients. Discussion of a potential user fee program should include identifying mechanisms to support innovation.”
Consumer Public Health Coalition’s Paul Brown said his organization supports providing FDA with additional resources through OTC user fees. “We are particularly concerned how the current process limits FDA’s ability to require new warning or labeling changes to address emerging safety and effectiveness issues in a timely manner,” he said. “FDA needs resources to provide ongoing surveillance of marketed products and to move quickly when issues arise... OTC user fees are also needed to support reexamination OTC products used in children. And fees should also support the development of product formulation standards... We recommend that user fees be structured as a product listing fee based on a sliding scale proportionate to the complexity and reviewing resources required... We would avoid structuring the fee as a facility fee, since it may have the unintended consequence of pushing sponsors to consolidate operations to a few facilities, and this could impact the supply chain and cause OTC product shortages.”
Proctor & Gamble global director Greg Collier said his firm supports fees to help ensure high-quality science, regulatory review and responsiveness for OTC monograph active ingredients. The program should not become a disincentive for manufactures to request new safety-related product enhancements, he told the meeting. “P&G recommends that user fees be directed towards measureable deliverables that facilitate new innovation and updated science to approve OTC monograph products,” he said, recommending the exploration of a hybrid funding model structured to provide predictable funding to support new capabilities and activities that benefit all manufacturers, while also including a fee for requested event components (meeting requests, application reviews).
Johnson & Johnson’s Jethro Ekuta said his firm also supports a user fee program for product listing and facility registration. “FDA should consider that OTC products generate less revenue than their prescription pharmaceutical counterparts and this should be considered by the agency in any decision on user fees,” he said. “It would be extremely difficult to justify an application-based user fee in the absence of any incentive to encourage innovation, such as a provision for exclusivity... The provision of a reasonable period of exclusivity based on the nature and extent of studies conducted to support development activities (such as new claims, new dosage forms, addition of new ingredients) is highly likely to encourage innovation and should be considered an important element of any application-based user fee program.
Sidley Austin lawyer Diane McEnroe, representing several OTC product companies, said her clients also favor user fees when tied to innovative new market entries with the establishment of related performance goals by the agency. Fees should be tied to efforts to move the OTC industry forward and “not to play catch up,” she said. “FDA must recognize that companies are hesitant to initiate the studies to support innovative therapies and to pay user fees if competitors can simply piggy back on that effort. We therefore support congressional establishment of incentives, such as product exclusivity, for industry submissions containing data that support innovation to a monograph product... Using PDUFA performance goals as a model, FDA could identify specific timelines and target goals for FDA to complete the review of a certain percentage of submissions. Finally, user fees that are tied to product listings, manufacturing sites, or sales numbers are not supported, as these will act as a disincentive to product introduction and maintenance of products alreadymarketed. User fees should not be used to finalize monographs across the board, especially as companies are marketing products in only certain therapeutic categories.”
FDA said interested persons may submit electronic or written comments on the potential user fee program for the next 30 days.