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Posted 10 May 2016 | By Zachary Brennan 

FDA Considers New User Fee Program for OTC Drugs


The US Food and Drug Administration (FDA) on Tuesday announced that it will gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs.

User fee programs (such as PDUFA, GDUFA, BsUFA and MDUFA, all of which are now being re-negotiated for 2017) are the life blood of FDA and provide much-needed financial resources from industry, in addition to Congressional appropriations, that support the timely and efficient review of the efficacy and safety of drugs, biologics and devices.

But unlike prescription drugs, which are regulated via new drug applications (NDAs), hundreds of thousands of OTC drugs are evaluated and approved via what are known as monographs. Sponsors of OTC drugs relying on monographs are not required to seek FDA approval prior to marketing a product under a monograph.  

“The OTC monograph process is ingredient-based, as opposed to product-based, and is done through a multi-step public rulemaking process,” FDA notes. “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.”

Currently, a number of pain-relievers, pediatric cough and cold medications, decongestants, upset stomach medicines and antiseptics can be marketed under an OTC monograph.

Lack of Resources

However, because of a lack of resources, FDA says the finalization of such OTC monographs has been slow in many therapeutic areas, with the result that there are OTC drugs on the market with still-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,” the agency said Tuesday.

One of the biggest issues for FDA is a lack of staff working on OTC monographs. FDA currently has 18 full-time-employees devoted to overseeing the entire OTC market, which is the same number of employees 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,” the agency says, noting that the OTC monograph drug review process remains one of the largest and most complex regulatory programs ever undertaken at FDA.

With about 88 simultaneous rulemakings in 26 therapeutic areas encompassing hundreds of thousands of products, FDA is currently overseeing 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,” the agency said.

Public Meeting

On 10 June, FDA will convene an eight-hour public meeting to gather stakeholder input on the development of the new user fee program for OTC drugs.

The agency is seeking input on:

  • 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 (particularly as premarket applications are not submitted and requiring application fees may not be feasible)?
  • 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 (particularly in terms of the stability and predictability of the funding provided by the user-fee)?

Federal Register Notice

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

Public Meeting: Over-the-Counter Monograph User Fees


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