Cephalon fights allegations of falsely promoting drugs for the wrong use
FRAZER, Pa. Cephalon has finalized an agreement with the United States Attorney’s Office for the Eastern District of Pennsylvania, the Department of Justice and other federal agencies concerning allegations that it promoted three drugs for uses that the Food and Drug Administration had not approved, the company announced Monday.
The allegations concerned the cancer-related pain drug Actiq (oral transmucosal fentanyl citrate), the sleep-disorder drug Provigil (modafinil) and the seizure drug GabitRil (tiagabine hydrochloride). Under the terms of the agreement, Cephalon will pay $425 million reserved last year plus $12 million interest and plead guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act. It will also enter into a five-year Corporate Integrity Agreement with the Office of the Inspector General of the Department of Health and Human Services.
Drug makers stop naming medications in TV ads
NEW YORK Some drug makers are using indirect tactics to market their drugs on television while dodging the Food and Drug Administration’s requirement to list side effects, the Wall Street Journal reported Friday.
The Journal highlighted a Pfizer commercial aired during the Beijing Olympics featuring a middle-aged woman talking about her smoking habit and detailing ways to quit smoking. The commercial directed viewers to the Web site www.mytimetoquit.com, which itself contained a link to Pfizer’s site for the anti-smoking drug Chantix (varenicline).
Under FDA regulations, companies must list side effects only if they directly name the drug.
The Chantix Web site does list the drug’s side effects, notably suicidal behaviors that earlier this year prompted the Federal Aviation Administration to ban its use among pilots.
NYC Health Dept. to supply free blood pressure monitors to pharmacies
NEW YORK The New York City Health Department is delivering free blood pressure machines to pharmacies in neighborhoods with residents suffering from the highest rates of hypertension, according to AM New York, a local newspaper.
The health department is providing the machines as part of a pilot program that went into effect in Harlem in the summer. The South Bronx and Brooklyn will be getting the machines in the next few weeks.
The agency says one in three people in Harlem, the South Bronx and in parts of Brooklyn suffer from high blood pressure. With no symptoms, it states, getting checked is the only way to know if someone has high blood pressure.