President Obama Signs the Drug Quality and Security Act

On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA) into law. Title I of the Act establishes national standards for compounding pharmacies designed to fill regulatory gaps that contributed to the 2012 meningitis outbreak. Title II—arguably the more important of the two …

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Physicians – Are You Ready for Sunshine Act Reporting?

In just two weeks, drug and device manufacturers will be required to start tracking and collecting data in connection with the Physician Payments Sunshine Act, which CMS refers to as the Open Payments program.  Available data suggests that while manufacturers are generally prepared, physicians may not be aware of …

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FDA Explains Decision Not to Seek Rehearing in Caronia

Yesterday FDA explained why it did not seek a rehearing of the Second Circuit’s December 3, 2012 decision in United States v. Caronia. In its decision (previously discussed here), the Second Circuit overturned the conviction of a sales representative for encouraging doctors to prescribe the suppressant Xyrem for …

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Is Off-Label Enforcement Off Limits?

On Monday, the Second Circuit Court of Appeals issued a split decision in U.S. v. Caronia, vacating the criminal conviction of a pharmaceutical sales representative who was found guilty of misbranding, in violation of the Food, Drug & Cosmetic Act (FDCA), because he had promoted the sleep medication Xyrem for …

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More Problems With ZPICs

A recent OEI report found troubling conflicts of interest and financial relationships among potential Zone Program Integrity Contractors (ZPICs) used by the Centers for Medicare & Medicaid Services (CMS) in their controversial new National Fraud Prevention Program.  Medicare fraud costs the government an …

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ERISA Preemption of Michigan Paid Claims Assessment Act

We previously posted regarding Michigan’s Paid Claims Assessment Act (the “Act”) which assesses carriers a 1% surcharge on paid health claims. The Act defines carriers to include group health plan sponsors, along with insurance companies and also assesses third party administrators. Thus, it is likely that …

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