The Food and Drug Administration approves a label for every drug marketed in the United States. “The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging.” While physicians may prescribe FDA approved drugs for off-label uses, it is illegal for the manufacturer to market one of its drugs for an off-label use.
John Carreyrou writes in the November 3, 2006, Wall Street Journal that while off label prescriptions may not be illegal, they can be dangerous to the patient’s health. He uses the powerful painkiller Actiq, which he describes as a highly addictive “narcotic lollipop” with an active ingredient fentanyl that is 80 times more powerful than morphine. Cephalon markets Actiq. The San Francisco Chronicle features today a first person account of Actiq abuse.
Actiq was approved for marketing in 1998. Its sales volume climbed from $15 million in 1999 to $412 million in 2005.
The Wall Street Journal story explains that
The Food and Drug Administration approved the drug eight years ago for use only in cancer patients who suffer intense bouts of pain that other narcotics don’t relieve. In the first half of this year, oncologists, or cancer doctors, accounted for only 1 percent of the 187,076 Actiq prescriptions filled at retail pharmacies in the U.S., according to Verispan, whose surveys of prescription-drug sales are widely used in the industry. Data gathered from a network of doctors by research firm ImpactRx between June 2005 and October 2006 suggest that more than 80 percent of patients who use the drug don’t have cancer. Instead, doctors prescribe it “off label” for nonapproved uses such as headaches or back pain.Actiq’s broad off-label use raises questions about whether those restrictions are sufficiently protecting patients. “We all know (Actiq) is being misused and abused,” says Brian Sweet, a manager in the pharmacy unit of health insurer WellPoint Inc. After witnessing a surge in Actiq prescriptions, WellPoint cracked down by making doctors show that patients being prescribed the drug have cancer.
The U.S. Attorney for the Eastern District of Pennsylvania is investigating Cephalon’s marketing practices, according to the Journal.