Expanded Fentora Approval a Bad Idea, FDA Panel Says

Cephalon Inc’s quest to expand the approved uses of the narcotic painkiller <"http://www.yourlawyer.com/topics/overview/fentora_overdose">Fentora hit a snag yesterday, as a Food & Drug Administration (FDA) panel voted 17-3 against the proposal. Panel members said they were concerned that expanding the use of Fentora beyond cancer patients would lead to more misuse of the highly-addictive drug, which has already been blamed for many overdose deaths. Currently, about 20,000 people use Fentora, but some expect that with expanded approval, that number would balloon to ten million.

Fentora was approved in 2006 only for treating pain in cancer patients. It is intended for patients who experience breakthrough pain because they have developed tolerances to other opiate painkillers. Fentora contains fentanyl, a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

While Fentora is only approved for cancer patients, it is known that as many 80 percent of people using it do so “off-label” to headaches and back pain. Once a drug has been approved by the FDA doctors are free to prescribe it as they see fit, but drug companies are legally barred from promoting off-label use. Cephalon has been the subject of several investigations into off-label promotion of Fentora and other narcotic painkillers. In November, the company 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 narcotic painkiller, Actiq.

Cephalon has reported five patient deaths due to negative reaction or overdose of the drug. In September 2007, the FDA issued a public health advisory, warning that several Fentora-related deaths had occurred in patients who were prescribed the drug for off-label use. The FDA advisory warned that Fentora should not be used for any other conditions including migraines, post operative pain or pain due to injury.

Despite the overdose dangers, Cephalon has continued to push the FDA to expand Fentora’s approved uses. At yesterday’s advisory panel meeting, however, FDA scientists testified that widening approval of Fentora could have dangerous effects because of the risks for improper prescribing and abuse of the drug, which is more potent than other pain medications.

Patients suffering from ailments like back pain and migraines already have access to many approved narcotics, causing many panelists to question the need for expanded Fentora approval. “How many people are we going to help with the release of this product and how many are we going to hurt?” asked panel member Dr. Charles Cortinovis, of the Veterans Administration Hospital in Pittsburgh. “In my mind it is very scary to release such a large amount of powerful opiate into the American population.”

Cephalon tried to ease fears over Fentora misuse by proposing a plan that would require pharmacists to electronically confirm a patient’s symptoms before dispensing the drug. While some panelists like that idea, they want Cephalon to perform more studies to prove its plan will help reduce medication errors and abuse of the drug. Several panel members also said Cephalon should conduct more studies to determine if Fentora offers more benefits to non-cancer patients than other painkillers already approved for such conditions.

The FDA is expected to make its final decision on Fentora by mid-September. Though the agency is not bound by the recommendations of advisory panels, it usually follows them.

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