The Respiratory Disease Network (RDN) is a group of three compounding pharmacies established by SourceCF in September 2004.
The litigation concerned the marketing of a compounded formulation of the antibiotic tobramycin for use in a drug delivery device. Chiron makes and markets Tobi tobramycin inhalation solution, USP, a product approved by the FDA for use in combination with the Pari LC Plus reusable nebulizer and a DeVilbiss pulmo-aide air compressor to treat pseudomonal lung infections in cystic fibrosis (CF) patients.
The drug-device combination marketed by RDN and other parties named in the lawsuit has not been clinically tested for safety or efficacy and is not approved by the FDA.
Under the terms of the agreement, which covers the compounding of tobramycin and the marketing of the drug delivery device, the RDN pharmacies are required to attach a disclaimer to any promotional materials related to the drug-device combination. The disclaimer must warn that compounded prescriptions are not evaluated by the FDA for safety or efficacy.
The disclaimer also must warn that the device in question has not undergone human clinical studies to determine its safety or efficacy and has not been approved by the FDA for use with tobramycin in the treatment of CF patients.
The case was resolved to the mutual satisfaction of the parties, although neither of the SourceCF entities admitted any liability.