FDA looking at Schering treatment refill delays

[Guest guest]

This article is not so much about the wait list as it is about the patients

ON the PEG-Intron access Assurance program who are reporting delays in

getting their refills.

FDA looking at Schering's treatment for hepatitis C

Schwab

Newark Star Ledger

01/24/02

The Food and Drug Administration is exploring concerns raised by patient

activists concerning how Schering-Plough Corp. distributes its new medicine

for treating the chronic liver disorder hepatitis C.

To prevent shortages, Kenilworth-based Schering-Plough required patients to

register and, more recently, warned of potential waiting lists. The

treatment consists of weekly injections of Peg-Intron plus capsules called

Rebetol.

Activists complain that some patients who have begun the 48-week treatment

had to wait up to 10 days to get prescriptions refilled, delays that can

disrupt the treatment. Without any of the antiviral Peg-Intron in the body,

the hepatitis C virus can rebound.

" Patients are missing doses of drug, a situation that can lead to viral

resistance and treatment failure, " Klein of the Hepatitis C Action and

Advocacy Coalition recently wrote the FDA, calling for an investigation.

Jay Siegel, director of the FDA's office of therapeutics research and

review, said the agency is " exploring its options and authorities " and will

follow up with the manufacturer of the product in an effort to help address

them.

Consalvo, a Schering- Plough spokesman, said the company is unaware

of any significant problems in distributing the medicine. More than 90

percent of prescriptions are filled within three days.

In addition, he said delays may be caused by other factors not within

Schering-Plough's control. The hepatitis C medicine normally is not stocked

by most pharmacies and must be ordered to fill prescriptions.

The company has said about 60,000 patients have signed up for the new

hepatitis C treatment.