Hydrocodone Combination Drugs Could Be Reclassified to Schedule II Category of Controlled Substances
By Lance O. Leider, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law A Food and Drug Administration (FDA) advisory committee voted 19 to 10 in favor of moving hydrocodone combination drugs from schedule III into the more restrictive schedule II category […]
Two National Recalls Prompt Food and Drug Administration (FDA) to Update Metal-on-Metal Hip Implant Safety Concerns
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Carole C. Schriefer, R.N., J.D., The Health Law Firm On January 17, 2013, the Food and Drug Administration (FDA) issued an updated public health communication about hip replacement components that have both a metal ball and a […]
Colorado Surgeon Accused of Botching Multiple Robotic Arm Surgeries
By Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law A Colorado surgeon allegedly faces 14 counts of unprofessional conduct associated with the use a robotic arm used during surgeries, according to the formal administrative complaint. The Colorado […]
Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the […]
More Than 7,000 Patients of Oklahoma Dentist Are Being Asked to Get Tested for HIV and Hepatitis
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The unsanitary practices of an Oklahoma dentist may have exposed more than 7,000 patients to HIV and hepatitis, according to a number of media sources and the Oklahoma Department of Health (DOH). Currently officials with the Oklahoma DOH […]
Supreme Court to Determine if Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers are Legal
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Supreme Court is currently looking into whether brand name drug manufacturers may pay generic drug manufacturers to keep the generic drugs off the market. These payments, often called pay-for-delay, are usually a form of settlement between the […]
Generic Drug Maker Ranbaxy Pleaded Guilty to Claims of Adulterated Drugs-Must Pay $500 Million Fine
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Generic drug maker Ranbaxy USA Inc., pleaded guilty to drug safety violations and will be responsible for paying $500 million in criminal and civil fines, according to the Department of Justice (DOJ). The fines will resolve claims that […]
Drug Quality and Security Act Boosts FDA Regulations Over Compounding Pharmacies
By Lance O. Leider, J.D., The Health Law Firm On November 18, 2013, the United States Senate voted to increase federal oversight of compounding pharmacies that produce large volumes of mixed drugs. This bill comes in the wake of last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). Click […]
Compounding Pharmacies Urged to Sign Up for U.S. Food and Drug Administration Oversight
By Lance O. Leider, J.D., The Health Law Firm It is estimated there are 3,000 compounding pharmacies in the United States, 14 of which have signed up to be regulated by the U.S. Food and Drug Administration (FDA) under the Drug Quality and Security Act. On January 8, 2014, the commissioner of the FDA sent […]
Florida’s Medicaid Program Receives Settlement Payment from Pharmaceutical Company
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Florida Attorney General’s (AG) Medicaid Fraud Control Unit (MFCU), 46 other states and the federal government reached a $48 million agreement with pharmaceutical company Healthpoint Ltd., on February 25, 2013. According to the Florida AG, the settlement […]