Drugs

DoJ Reiterates Compliance Evaluation Factors

A recent updated Justice Department guidance intended to help department prosecutors evaluate corporate compliance programs in the context of investigations of business entities confirms that three fundamental issues are relevant to any such evaluation. Attorneys Gregory Brower and Stanley Garnett (Brownstein Hyatt Farber Schreck) write in a Washington Legal Foundation Legal Pulse blog post that the factors are the program’s design, implementation, and effectiveness.

“The new guidance … clearly emphasizes the importance of effective compliance in the context of the department’s consideration of corporate culpability, while reaffirming that DoJ does not use any rigid formula when assessing the effectiveness of such programs,” the two write. “The guidance acknowledges that compliance programs must be evaluated in the specific context of the relevant criminal investigation, requiring an individual determination in each case.”

They say the guidance should remind corporate officers and directors of the importance the department places on compliance efforts when evaluating whether to charge, not charge, or otherwise agree to a deferred prosecution agreement or non-prosecution agreement. “Companies of all types and sizes,” they conclude, “are well-advised to take compliance seriously.”

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