* Cephalon says only FDA has oversight of off-label uses
* Insurer says paid for thousands of off-label prescriptions
July 13 (Reuters) – The drugmaker Cephalon Inc has sued
Travelers Cos to stop the insurer from trying to recover
millions of dollars it allegedly paid for off-label uses of
Actiq, a prescription medication to treat pain in cancer
patients.
Cephalon, a unit of Israel’s Teva Pharmaceutical Industries
Ltd, said Travelers has demanded that it reimburse
$17.4 million stemming from the off-label promotion of the drug.
Such promotions involve uses of a drug not approved by
regulators.
While Cephalon settled with U.S. federal and state
regulators in 2008 over similar allegations, it said federal law
entrusts the U.S. Food and Drug Administration with oversight of
off-label promotion and does not give Travelers the right to
bring its own case.
Cephalon said Travelers threatened to sue if its demands
were not addressed by July 13, prompting Cephalon to ask the
federal court in Manhattan to declare that it owes nothing.
Travelers officials could not immediately be reached for
comment.
In a letter attached to Cephalon’s complaint, a Travelers
lawyer claimed the insurer has covered more than 8,400 Actiq
prescriptions for more than 480 non-cancer patients with
maladies including back strain, bone fractures, burns,
concussions, contusions, dislocations, hernias and slipped
discs.
Cephalon, based in Frazer, Pennsylvania, is best known for
its Nuvigil drug to improve wakefulness.
Actiq is the drug Fentanyl, taken by lollipop, and used to
manage pain in cancer patients receiving and tolerant to
around-the-clock opioid therapy.
Lawyers in other cases have alleged that oncologists order
only a small percentage of Actiq prescriptions.
The case is Cephalon Inc v Travelers Cos, U.S. District
Court, Southern District of New York, No. 11-05395.
