Drugs

WLF Brief Asks High Court to Review ‘Responsible Corporate Officer’ Case

Washington Legal Foundation has asked the U.S. Supreme Court to review and ultimately overturn a divided Eighth Circuit ruling that upheld a term of imprisonment for two executives of Quality Egg LLC under the “responsible corporate officer” (RCO) doctrine. In a brief filed in DeCoster v. United States, WLF argues that by “depriving the defendants of their liberty based on employee misconduct of which defendants were unaware,” the lower court decision “expands the RCO doctrine far beyond what Supreme Court precedent or the Due Process Clause permits.” The case involves father and son Austin and Peter DeCoster, former executives of Quality Egg, who have appealed a three-month prison sentence for misdemeanor violations of the FFDCA involving distribution of egg products.

In the brief, WLF argued that “although the Supreme Court has permitted the imposition of strict criminal liability in the absence of mens rea in the narrow category of public welfare offenses, it has done so only with the understanding that penalties imposed in such cases will be relatively small and the conviction will not gravely damage defendant’s reputation.” The appeals court’s ruling “expands such strict supervisory liability far beyond the constitutional bounds the Supreme Court first articulated when adopting the RCO doctrine over 70 years ago,” WLF contends.

Upon filing its brief, WLF counsel Cory Andrews had this to say: “FDA officials give every indication they view the draconian penalties imposed here — including the prison terms — as a model for similar cases. Either they don’t understand the limits of the ‘responsible corporate officer’ doctrine, or else they are deliberately acting contrary to Supreme Court precedent.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome