FDA setting stage for NDUFA with June public meeting

SILVER SPRING, Md. - OTC suppliers may soon have a streamlined highway to the kind of sales-driving product innovation that Rx-to-OTC switch generates using monographs, according to an announcement from the Food and Drug Administration issued Tuesday. However, it may be a toll road.

 

FDA announced a public meeting on June 10 that will take place here to gather stakeholder input on the potential development of a user fee program for nonprescription 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. 

 

According to the agency, the lack of resources the FDA is able to dedicate to monograph review has slowed the finalization of monographs 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.

 

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 agency noted. 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.

 

Presently, 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 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.

 

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. 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.