FDA Guidance on Sinusitis and Its Potential Impact on Treatment

Fortunately, some efficacy and safety data are available for medical treatment of CRS. The solitary Cochrane systematic review related to medical management of CRS supports the role of nasal saline for symptom relief. In a similar fashion, data exist that support the role of several intranasal corticosteroids in the treatment of nasal polyposis.7 At present, these intranasal corticosteroid trials are the only studies that have been subjected to the regulatory oversight of the FDA, thus raising the validity of the resultant data and its interpretation to that of the standard for medical treatment of other disease processes.

So, why do no FDA-approved medications indicated for the treatment of CRS exist? The answer is simple. Until recently, the FDA did not endorse a definition for CRS. Given the extensive costs related to drug development, this absence of a simple working definition for chronic rhinosinusitis essentially removed all incentive to the pharmaceutical industry for investment in a drug that could never receive an indication for its targeted disease process. In fact, the current indications for intranasal corticosteroid sprays exist for nasal polyposis and not for chronic rhinosinusitis, representing a fortunate loophole of sorts. So, what appears to be crucial to the development of improved treatment modalities for CRS is the collaborative cooperation of physician groups, industry, and regulatory agencies.

Collaborations among academic researchers, regulatory agencies, and pharmaceutical manufacturers have long existed, and have served an important role in the process of preclinical and clinical drug development programs. The relationships and motivations of each of the bodies are, by their very nature, adversarial at times. Nevertheless, it is this very collaboration that appears to be necessary to move forward. During product development, conflicts of interest arise, which are impossible to avoid and instead must be acknowledged and managed. The innate conflicts that present within these collaborations must be balanced with the potential to develop new products for patient care.8

Steps in the Right Direction

Reflecting on the course of events that have lead to recent regulatory changes, it is clear that efforts by members of the medical community set the stage to move forward. In 2002, Michael Benninger, MD, under the direction of the Sinus and Allergy Health Partnership, convened a task force to define chronic rhinosinusitis. The results of that meeting resulted in the first published definition for chronic rhinosinusitis. In its most simplified form, chronic rhinosinusitis was defined as an inflammatory process involving the mucosa of the nose and paranasal sinuses lasting for more than 12 weeks.2 This definition served as a catalyst for further discussion and codification of a definition for the disease. Opposition to certain nuances of the definition was voiced. Two areas of continued difference relate to the use of the term rhinosinusitis as opposed to sinusitis, and to temporal aspects of the disease, but the fundamentals of the definition arguably remained largely intact.