FDA Reviewing Schering-Plough’s Distribution of Hepatitis C Medicine After Patients Complain of Prescription Refill Delays
The FDA is looking into patient advocate concerns that Schering-Plough Corp.'s distribution of its new hepatitis C therapy is causing disruptions in treatment, the Newark Star-Ledger reports. Some patients have had to wait up to 10 days to receive prescription refills -- delays which disrupt therapy and can prompt hepatitis C viral load to "rebound." In an attempt to prevent shortages of the treatment -- a combination of weekly PEG-Intron injections and ribavirin capsules -- Schering-Plough has required patients to register to receive the treatment and last week "warned" patients of possible waiting lists for the drugs. "Patients are missing doses of drug, a situation that can lead to viral resistance and treatment failure," Brian Klein of the Hepatitis C Action and Advocacy Coalition said. "[U]naware" of any distribution problems, Schering-Plough spokesperson Robert Consalvo said that "more than 90% of prescriptions are filled within three days" and that some delays result from "factors not within Schering-Plough's control," as most pharmacies do not stock the treatment and must order it to fill prescriptions (Newark Star-Ledger, 1/24). Schering-Plough reports that approximately 60,000 patients have registered for the treatment, which is more effective than previous hepatitis C drugs (Kaiser Daily HIV/AIDS Report, 1/16).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.