Frequently Asked Questions: June 10, 2016 Public Meeting on OTC Monograph User Fees

Q1. What are over-the-counter (OTC) drugs and how do they come to market?
A1: OTC drugs can be purchased by consumers without a prescription. OTC drugs have to be effective and safe for use without the supervision of a healthcare professional such as a physician. These drugs are sometimes approved under applications that are similar to the applications for new prescription drugs, but more often OTC drugs are legally marketed without an application by following a regulation called an OTC drug monograph.

An OTC drug monograph describes the conditions of use under which active ingredients are considered generally recognized as safe and effective for inclusion in an OTC drug. Conditions of use may include, for example, the appropriate dose and instructions for use. OTC products that meet all applicable legal requirements, including a monograph’s requirements, may be marketed without an approved application. OTC products that do not fit under an existing monograph must be approved under an application like the applications for prescription products to lawfully be marketed. More at: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194951.htm (FDA Archive).

Q2. What are examples of OTC medicines marketed under an OTC monograph?
A2: Some pain-relievers, pediatric cough and cold medications, decongestants, medicines for stomach upset, and antiseptics are just a handful of the examples of medicines that can be marketed under an OTC monograph. The lack of resources the FDA is able to dedicate to monograph review has slowed the finalization of monographs in many of these therapeutic areas with the result that there are OTC drug products on the market under pending monographs and for which the FDA has not made a final determination on safety and effectiveness. The lack of resources has also slowed FDA’s ability to accommodate potential innovation, and has presented challenges to the timely addition of new safety information to monographs.

Q3. Why is the FDA holding a meeting about OTC user fees?
A3: The FDA is announcing a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user fee program would provide funding to supplement congressional non-user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.

Q4. Why does the FDA want to modernize the OTC monograph review process and how are user fees a part of the reform efforts?
A4: In large part, the OTC monograph drug review process has been successful – the FDA was able to make determinations about the general recognition of safety and efficacy of the active ingredients in thousands of OTC products through this process. However, rapidly evolving science, emerging safety issues, and drug development innovations require a more agile and responsive process than the process the FDA set up in the early 1970s in order to serve the public health effectively. The FDA also needs additional resources to modernize the OTC review process to keep up with evolving science and the fast pace of the pharmaceutical and consumer healthcare products industry, and to finalize the pending monographs. There has been substantial growth in the number of OTC products on the market and it is part of the FDA’s mission to ensure that these OTC drugs are safe and effective for consumers to use.

Q5: What is the FDA’s current funding for OTC monograph work?
A5: Most OTC drugs are marketed under the monograph, and the FDA is critically under-resourced in this area. The FDA currently has 18 full-time-employees (FTEs) devoted to overseeing the entire OTC market. This is the same number of FTEs it takes to review one novel prescription drug application. The FDA estimates that at the current funding level, it would take multiple decades to review and finalize the spectrum of drug monographs that are currently in non-final status. Because the FDA prioritizes activities by public health need, it is likely that, in the absence of additional funding, most of the FDA’s monograph review resources would need to go toward addressing urgent safety issues, with definitive action on the general safety and effectiveness of non-final monograph drugs and innovation review occurring only as strained resources permit.

Q6: If the FDA had a user fee program, what would the FDA do with the additional resources?
A6: Millions of American consumers every year use OTC drug products to self-manage numerous conditions. The supplemental resources that a user fee program could provide to the FDA could, for example, support and expedite review of the safety and effectiveness of currently-marketed OTC ingredients, thereby improving public health. Finalizing FDA review of these ingredients, as well as the devoting additional resources to expeditiously modify labels for new safety concerns, would better inform the public and provide for greater regulatory flexibility and assurance. In addition, a user fee program could benefit industry and the public, for example by allowing for more timely review of eligible innovations and new ingredients or other conditions under a monograph, ultimately leading to the availability of new and improved OTC drugs to the American public. FDA invites input on the types of activities that additional resources from potential user fees should support.

Q7: What is the difference between a monograph and a new drug application?
A7: A new drug application or NDA is a confidential marketing application industry submits to the FDA for review. If approved, the specific NDA product may be legally marketed in the U.S. The OTC monograph process is ingredient-based, as opposed to product-based, and is done through a multi-step public rulemaking process. The monograph allows industry to market a drug product that contains a monograph ingredient as long as the manufacturer complies with all applicable regulations, including the conditions of the monograph. The NDA process involves user fees paid by sponsors of NDAs. As part of the periodic reauthorization of prescription drug user fees, FDA commits to various goals, including specific time frames for reviewing NDAs. Currently, there are no user fees for OTC monographs and also there are no review timelines.

Q8: I have heard of Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA). Would an OTC monograph user fee program be similar to those programs?
A8: PDUFA and GDUFA have allowed both the new drug and generic drug application review processes to modernize by providing resources and allowing for more timely and efficient review of applications. User fees for OTC monographs could potentially have a similar positive effect for OTC monograph products

Public Meeting: Over-the-Counter Monograph User Fees