Posted 01 August 2017
By Michael Mezher
After a series of discussions with industry and a public meeting in June 2016, the US Food and Drug Administration (FDA) last week released its draft goals letter for the proposed over-the-counter (OTC) monograph user fee program.
The agency also announced on Tuesday that it will host a webinar to provide an overview of the proposed program to stakeholders on 23 August 2017.
OTC Monograph User Fees
Dubbed OMUFA, short for the yet-to-be introduced Over-the-Counter Monograph Drug User Fee Act, the program would allow FDA to collect fees from industry for monograph related activities.
Unlike prescription drugs, which require a new drug application (NDA) to be marketed, certain OTC drugs can be marketed based on compliance with a monograph and do not require preapproval by FDA. But, due to a lack of resources, FDA has been slow to finalize OTC monographs in many therapeutic areas.
Specifically, the goals letter lays out a framework for two tiers of industry submitted OTC monograph order requests (OMORs), timelines for their review and FDA's performance commitments for completing those reviews. The letter also establishes specific goals for staff and infrastructure enhancements for the agency to meet those goals.
While the draft goals letter presumes the five-year program will begin at the start of the fiscal year on 1 October 2017, it's unclear when Congress will actually take up legislation to enact the program.
OTC monograph user fees were not included in the bill to reauthorize FDA's other user fee programs that was passed in the House last month, and so far the Senate has not moved to include the program in its user fee reauthorization bill, which is expected to see a vote before the Senate adjourns for its delayed recess next week.
The goals letter acknowledges this uncertainty, and notes that all targets will be adjusted according to the program's actual start date.
Under the draft agreement, FDA commits to hiring more than 100 new full-time employees over the course of the five-year program, beginning with 30 new hires in its first year.
This would be a significant expansion of the agency's OTC monograph staff, as FDA says it will enter the program with around 35 full-time equivalent employees, six of which are expected to be recent hires.
And, while the new reviewers will begin work immediately upon being hired, FDA says it will take two years before they are fully up to speed.
As a result, FDA says its monograph review capacity will scale up on a slight delay from its hiring targets.
"During the early years of OMUFA, although FDA will be striving to meet onboarding targets, FDA will actually not begin to see significant growth in effective review capacity until FY2020," FDA says, noting that its capacity will continue to rise after the program ends as the reviewers brought on in its last two years complete their training.
FDA also says that for the first three years of the program, a large portion of its resources will go towards existing monograph obligations under the Sunscreen Innovation Act and court-mandated activities from the triclosan antiseptic consent decree, and to startup activities for OMUFA, such as leadership development, building an IT platform and planning out monograph activities.
"Resource estimates indicate that, in order to implement all these activities and continue externally mandated activities, FDA will be substantially 'net-negative' in terms of effective review capacity for the first three years of OMUFA," the letter says.
As such, the agency will only be committed to goals on hiring and developing guidance in the program's first three years. In the third year those goals will expand to performance goals for holding meetings, and in the last two years of the program, FDA says it will be ready to hold itself to "limited performance goals" for over-the-counter monograph order requests.
Goals Letter, Federal Register Notice