FDA Proposes “Sinusitis” Exclusion From OTC Nasal Decongestant Monograph

FDA is seeking to amend the OTC nasal decongestant monograph by removing the indications that reference "sinusitis," the agency announced in a proposed rule slated for publication in the Aug. 2 Federal Register.

Under the proposal, FDA would eliminate the indication: "for the temporary relief of nasal congestion associated with sinusitis."

"Due to the data contained in recent publications and the potential medical harms, FDA now considers the indication...inappropriate and potentially misleading in labeled uses for OTC nasal decongestant drug products. Consumers could interpret this indication to mean that the product can be used for self-treating sinusitis," the agency maintains.

If adopted, the rule would impose a one-time compliance cost of $1.6 mil. to $2 mil. across the entire industry, FDA says.

In its analysis of economic impact, the agency conducted a label review to determine that roughly 26% of nasal decongestants carry sinusitis claims. Extrapolating the numbers to 2,000 SKUs, FDA maintains that 520 SKUs would need to be relabeled at a cost of $3,000 to $4,000 each.

However, FDA notes the actual cost likely would be less, due in part to the many labeling changes that will be made by private labelers, which use "simpler and less expensive labeling."

Additionally, manufacturers would have 18 months (24 months for products with annual sales of less than $25,000) to implement the new rule after its date of final publication.

FDA believes the extra costs of the proposal will be less than one percent of any manufacturer's total sales. The agency does not expect the added requirement to "significantly" impact OTC sales of the affected products.

FDA first announced its intention to propose the amendment in a January publication of the HHS "unified agenda" and stated its action was prompted by recent publications evaluating the role of nasal decongestants in sinusitis treatment (¹ (Also see "Nasal Decongestants Monograph Amendment On Sinusitis Claims Planned" - Pink Sheet, 19 Jan, 2004.), p. 11).

FDA cites that "prospective studies on the role of nasal decongestants in the treatment of sinusitis are lacking, and the data on their use as an adjunct in the treatment of sinusitis are limited and controversial."

Specifically, FDA points to a 1998 supplement to the Journal of Allergy and Clinical Immunology entitled "Parameters for the Diagnosis and Management of Sinusitis." The agency also cites a 2001 Pediatrics article "Clinical Practice Guideline: Management of Sinusitis."

The agency maintains some nasal decongestants may actually worsen sinusitis and says: "there is preclinical evidence that topical nasal decongestants may have a negative effect on the resolution of sinusitis, as they may increase the degree of sinus inflammation."

FDA also points out that use of OTC nasal decongestants should not replace a consumer's visit with a physician. Although the products often are recommended or prescribed by healthcare professionals, OTC treatment "should not be construed as evidence that consumers should self-diagnose and self-manage sinusitis."

"FDA is concerned that consumers use OTC nasal decongestant drug products (both oral and topical) to treat symptoms associated with sinusitis, rather than seeking medical evaluation and definitive treatment."

A delay in medical evaluation by a physician could prevent early diagnosis of other medical conditions that have symptoms similar to those caused by sinusitis, the agency maintains.

For example, "consumers who have both sinusitis and accompanying asthma could have complications from both diseases if there is a delay in appropriate evaluation and treatment of their asthma." FDA points out that approximately 31 mil. Americans develop sinusitis each year.

OTC nasal decongestant marketers will be given some leeway with indications associated with sinusitis. The proposal does not affect indications that read "helps decongest sinus openings and passages," "temporarily relieves sinus congestion and pressure" or "promotes nasal and/or sinus drainage."

Comments on the proposal will be accepted for 90 days following its publication in the Federal Register.