Cephalon Inc., a Frazer, PA–based pharmaceutical company plead guilty in federal court for marketing 3 drugs for uses other than they were approved for. According to an article in the Philadelphia Daily News, Cephalon has agreed to pay $437 million in fines, forfeitures, interest, and civil claims for distributing these misbranded drugs.
Cephalon, which develops and markets drugs to treat cancer, epilepsy, and sleep disorders, to name a few, marketed Actiq, Gabrivil, and Provogil for uses other than what was approved by the US FDA. Although doctors may prescribe drugs for uses other that what has been approved by federal regulators, pharmaceutical companies may not promote “off-label” uses.
The Philadelphia Daily News reported that the off-label marketing began in January 2001 and continued through 2006, but the plea agreement stated that the conduct went from January 2001 to October 1, 2001. Cephalon has not admitted any wrong doing as part of the civil settlement tentatively approved last November. US Attorney Laurie Magid said, “…The company put patients’ health at risk for nothing more than boosting its bottom line.”
Actiq, dispensed as a lollipop, is only approved for cancer patients and is a highly addictive narcotic. Cephalon marketed it for maladies including migraines and injuries. Gabrivil is an anti-epilepsy drug used to treat seizures, but was promoted as a remedy for anxiety, insomnia, and pain. Provogil is for excessive sleepiness associated with narcolepsy and sleep apnea. This was promoted for the treatment of sleepiness, lack of energy, and fatigue.
US Attorney Magid also said that authorities had reports that patients who had been taking the drugs for off-label issues were harmed or even died. However, she did not say at this time if the off-label use was the result of the marketing.
After reports of seizures in patients without epilepsy taking Gabrivil, Cephalon was ordered by the FDA to send warning letters to doctors. They also then stopped promoting the drug.
Cephalon was also instructed by the FDA to stop promoting Provogil off-label, but according to authorities, they ignored the letter. The feds said in the plea agreement that Provogil sales increased from 146.2 million in 2001 to $691.7 million in 2006.
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Drug maker completes $437 million settlement over off-label drug marketing