Drug & Device News

Huge Settlement in Misbranding Case

Federal District Court Judge Samuel Wilson on Oct. 1 imposed a massive fine on Abbott Laboratories for marketing its drug, Depakote, for uses never approved by the U.S. Food and Drug Administration (FDA). For promoting Depakote as a treatment for schizophrenia and as means of controlling undesirable behavior in dementia patients, the drug manufacturer was ordered to pay a fine of $500 million, to forfeit nearly $200 million, and to pay the Virginia Medicaid Fraud Control Unit $1.5 million. These amounts are in addition to the $800 million the company has already pledged to pay the federal government and a number of states to resolve claims that Depakote's fraudulent marketing caused false claims to be filed with those entities. According to the U.S. Department of Justice for the Western District of Virginia, which announced the judgment, this is the second-largest criminal fine of all time for the misbranding of a single drug.

Partial Victory for Ohio Restriction on Early-Pregnancy Abortion Method

Three of Planned Parenthood's challenges to an Ohio law that limits some patients' access to the drug mifepristone (commonly known as RU-486) were rebuffed by the U.S. Court of Appeals for the Sixth Circuit in Planned Parenthood Southwest Ohio Region v. DeWine on Oct. 2. The law, Ohio Rev. Code ' 2919.123, was enacted in order to limit Planned Parenthood and other health care providers from prescribing the drugs to patients who are further along in their pregnancies (up to 63 days' gestation) than those for whom the FDA has approved the RU-486 regimen (patients at up to 56 days' gestation). Although such off-label prescription is allowed under federal law, the states are permitted to place limits on off-label drug use. The Ohio law imposes criminal sanctions on medical providers who prescribe an RU-486 regimen in any manner not in conformance with the FDA's protocols and gestational time limits. The majority agreed with the trial court that the 2004 law is not unconstitutionally vague and does not violate a woman's 14th Amendment rights to bodily integrity or to choose to have an abortion. One issue remains, and is set to be decided after trial: whether the Act unduly burdens a woman's 14th Amendment right to health and life.

City Stands Up to the Feds, Fights for Marijuana Dispensary

The City of Oakland, CA, has filed suit against the United States seeking to halt the Department of Justice's (DOJ) move to seize property leased there by a large medical marijuana dispensary. The DOJ filed forfeiture paperwork in June, forcing Harborside Health Center to the shut the dispensary that had previously served several hundred patients per day. Prior to its closing, Harborside was operating under a business license issued to it by the City of Oakland, in accordance with California law, and was reportedly the city's second largest taxpayer.

FDA Inspection Finds Numerous Problems at New England Compounding
Center

Prompted by the national outbreak of meningitis cases linked to steroid injectables manufactured at the New England Compounding Center (NECC) in Massachusetts, the FDA conducted an inspection of the facility. The agency found several issues: One of these was the confirmation that, as was already generally known, NECC had been violating the law by producing drugs in large batches for unknown numbers of patients, instead of compounding drugs based on individual patient prescriptions. Also concerning was the fact that the company's plant sits next to a recycling center that produces copious quantities of airborne pollutants. The agency tested several vials of NECC product and found evidence of possible foreign matter in about one quarter of them. As of Oct. 27, 25 people had died of the meningitis that, it is suspected, was caused by exposure to tainted pain-relief injectable products distributed by NECC.

Meanwhile, Massachusetts authorities persuaded another compounding pharmacy in that state to surrender its license after a late-October Massachusetts Public Health Department inspection of the company's facility identified potential contamination issues. The company, Infusion Resource of Waltham, MA, had apparently been administering intravenous drugs to patients on site, an activity that state regulations prohibit. No evidence of contaminated drugs at Infusion Resource had been found prior its closing.

Huge Settlement in Misbranding Case

Federal District Court Judge Samuel Wilson on Oct. 1 imposed a massive fine on Abbott Laboratories for marketing its drug, Depakote, for uses never approved by the U.S. Food and Drug Administration (FDA). For promoting Depakote as a treatment for schizophrenia and as means of controlling undesirable behavior in dementia patients, the drug manufacturer was ordered to pay a fine of $500 million, to forfeit nearly $200 million, and to pay the Virginia Medicaid Fraud Control Unit $1.5 million. These amounts are in addition to the $800 million the company has already pledged to pay the federal government and a number of states to resolve claims that Depakote's fraudulent marketing caused false claims to be filed with those entities. According to the U.S. Department of Justice for the Western District of Virginia, which announced the judgment, this is the second-largest criminal fine of all time for the misbranding of a single drug.

Partial Victory for Ohio Restriction on Early-Pregnancy Abortion Method

Three of Planned Parenthood's challenges to an Ohio law that limits some patients' access to the drug mifepristone (commonly known as RU-486) were rebuffed by the U.S. Court of Appeals for the Sixth Circuit in Planned Parenthood Southwest Ohio Region v. DeWine on Oct. 2. The law, Ohio Rev. Code ' 2919.123, was enacted in order to limit Planned Parenthood and other health care providers from prescribing the drugs to patients who are further along in their pregnancies (up to 63 days' gestation) than those for whom the FDA has approved the RU-486 regimen (patients at up to 56 days' gestation). Although such off-label prescription is allowed under federal law, the states are permitted to place limits on off-label drug use. The Ohio law imposes criminal sanctions on medical providers who prescribe an RU-486 regimen in any manner not in conformance with the FDA's protocols and gestational time limits. The majority agreed with the trial court that the 2004 law is not unconstitutionally vague and does not violate a woman's 14th Amendment rights to bodily integrity or to choose to have an abortion. One issue remains, and is set to be decided after trial: whether the Act unduly burdens a woman's 14th Amendment right to health and life.

City Stands Up to the Feds, Fights for Marijuana Dispensary

The City of Oakland, CA, has filed suit against the United States seeking to halt the Department of Justice's (DOJ) move to seize property leased there by a large medical marijuana dispensary. The DOJ filed forfeiture paperwork in June, forcing Harborside Health Center to the shut the dispensary that had previously served several hundred patients per day. Prior to its closing, Harborside was operating under a business license issued to it by the City of Oakland, in accordance with California law, and was reportedly the city's second largest taxpayer.

FDA Inspection Finds Numerous Problems at New England Compounding
Center

Prompted by the national outbreak of meningitis cases linked to steroid injectables manufactured at the New England Compounding Center (NECC) in Massachusetts, the FDA conducted an inspection of the facility. The agency found several issues: One of these was the confirmation that, as was already generally known, NECC had been violating the law by producing drugs in large batches for unknown numbers of patients, instead of compounding drugs based on individual patient prescriptions. Also concerning was the fact that the company's plant sits next to a recycling center that produces copious quantities of airborne pollutants. The agency tested several vials of NECC product and found evidence of possible foreign matter in about one quarter of them. As of Oct. 27, 25 people had died of the meningitis that, it is suspected, was caused by exposure to tainted pain-relief injectable products distributed by NECC.

Meanwhile, Massachusetts authorities persuaded another compounding pharmacy in that state to surrender its license after a late-October Massachusetts Public Health Department inspection of the company's facility identified potential contamination issues. The company, Infusion Resource of Waltham, MA, had apparently been administering intravenous drugs to patients on site, an activity that state regulations prohibit. No evidence of contaminated drugs at Infusion Resource had been found prior its closing.