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Fentora Off-Label Marketing Charges Settled, Now Cephalon Wants to Expand Use of Addictive Painkiller

Nov 13, 2007 | Parker Waichman Alonso LLP

Fentora, a potent painkiller, has been linked to several deaths due to its misuse. Yet Cephalon, Inc. just announced it has submitted a request to the Food & Drug Administration (FDA) seeking approval to market Fentora—fentanyl buccal—for the management of breakthrough pain in opioid-tolerant noncancer patients.  An odd request given that Cephalon’s illegal marketing practices have been under constant scrutiny in recent years.  In fact, Cephalon just reached an agreement with the US Department of Justice to pay $425 to settle charges stemming from the illegal marketing of Fentora, as well as another of its painkiller, Actiq

In 2006, the Wall Street Journal investigated Cephalon’s marketing of Actiq—a pain-management cancer medication—and discovered that 80 percent of patients prescribed Actiq were not cancer patients and that Cephalon frequently focused marketing of Actiq to noncancer physicians in the sports medicine and family practice specialties.  That same year, the Connecticut Attorney General discovered that Cephalon marketed Actiq for off-label use—purposes other than the drug’s intention—and set high sales quotas that could only be met through off-label dispensing.  Of note since Actiq has been linked to over 120 deaths.

Most recently, Cephalon’s marketing of Fentora—a potent cancer pain management drug—has been under investigation by the US Attorney in Philadelphia, the Connecticut Attorney General, and Congress.

Both Fentora and Actiq are FDA-approved only for use in cancer patients for break-through pain, a type of pain that that occurs quickly, is severe, and is of short duration. Fentora is contraindicated for noncancer-related pains and for cancer patients intolerant to or not undergoing constant opioid therapy.  The drug is indicated for a very specific population, is a faster acting version of Actiq, and is not a generic version of any opioid-containing drug.  Because Fentora is dosed to deliver higher amounts of the opioid fentanyl—a highly addictive opiate 80 times more powerful than morphine—it is never to be substituted for any other drug since misuse at any dose can and has resulted in death.

Doctors are free to prescribe FDA-approved medications as they see fit, including off-label.  It is off-label marketing of FDA-approved medication—marketing for uses not approved by the FDA—which is illegal.  Off-label marketing is misleading and, in the case of Fentora, has been linked to four deaths, none of which occurred in cancer patients. Cephalon admitted that some of these deaths were the result of off-label use.  The FDA reports that other Fentora deaths have been due to doctors prescribing higher-than-recommended doses of the drug, a dangerous situation in light of the fact that over 80,000 prescriptions have been written for Fentora, a suspiciously large amount given the very limited population able to take the drug.

The FDA has mandated Cephalon to strengthen drug warnings and improve dosing instructions and education plans.  And although Cephalon has denied it marketed Fentora and Actiq outside their indication and claims the problems are a result of improper prescribing, they have agreed to pay $425 million to settle the US Justice Department investigation; agreed to a misdemeanor violation of the US Food, Drug, and Cosmetic Act; and will enter into a corporate-integrity agreement with the Department of Health and Human Services.

But, none of this stopped Cephalon from submitting their request to the FDA seeking approval to continue marketing Fentora for noncancer pain management.