In a Federal Register (FR) Notice published today, FDA indicates that it is seeking comments from the industry and the public on a potential user fee program to support an efficient over-the-counter (OTC) to support the OTC monograph review process.
FDA notes that, while overall aspects of the drug, biologics and device review process are funded in part by user fees, the OTC monograph process that deals with “hundreds of thousands of drug products marketed under the monograph system” is not. The FR notice (found here) goes on to say
The OTC monograph drug review process remains one of the largest and most complex regulatory programs ever undertaken at FDA. There are approximately 88 simultaneous rulemakings in 26 broad therapeutic areas encompassing hundreds of thousands of products. There are approximately 800 active ingredients for over 1,400 different therapeutic uses. FDA needs additional resources to work toward finalization of the monograph review process and to address safety issues in a more efficient and timely manner. Additional resources would also better enable the Agency to consider innovations for drug products containing monograph ingredients, such as the development of new dosage forms for ingredients under existingmonographs.
The monograph system is a bit different that the drug approval process where a single drug product is reviewed for its use and indications. OTC monographs are written more generally, where there may be a group of GRASE (generally recognized as safe and effective) ingredients that can be used singularly or in combination and sometimes in multiple dosage forms under a single general monograph. The notice describes the current monograph process, discusses the benefits of a user fee product and talks about the need for a stable source of resources to support the program initially and the ongoing review.
The notice goes on to say:
“FDA seeks input on the following questions and welcomes any other relevant information the public would like to share.
What types of user fees (e.g. product listing fees, facility fees, application fees, other types of fees) might be appropriate for a potential monograph user-fee program?
Consider the following in your answer:
For monograph products (unlike for products currently covered by user-fee programs), premarket applications are not generally submitted, and thus the approach regarding application-based fees might be expected to be different for a monograph user fee program compared to other user fee programs.
Desirable industry activities or behavior that might be discouraged by the assessment of fees.
The stability and predictability of the funding provided by the user-fee type.
In conjunction with receiving user fees, FDA typically commits to certain performance goals related to the Agency’s activities with respect to the relevant products. What types of performance goals might be important to consider from a public health and sponsor perspective? What parameters could be measured to gauge the success of a user-fee program?”
Funding for FDA activities are clearly shifting from all appropriate funds to more user fees based streams. While is this an international phenomenon, it looks like the FDA is looking to utilize private funds everywhere it can to improve efficiency and, in turn, will offer reasonable goals for completion of the activities covered by the user fee program. Get ready to open your wallets yet again.
