FDA Policy/General

‘Yates Memo’ Accountability Eased

The Department of Justice says that after a year-long review of the “individual accountability policy” enunciated by then-deputy attorney general Sally Yates in a 2015 memo, it is reforming the policy to provide more potential for companies to earn cooperation credit and to resolve cases more quickly. Attorney Anne Walsh (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that “FDA-regulated companies should welcome these developments, although some additional clarity still is necessary.”

The Yates memo had directed Justice Department prosecutors to pursue culpable individuals in all civil and criminal investigation involving corporate misconduct. For criminal cases, the revised policy takes into account the problem companies face when it is difficult, if not impossible, to identify every individual who was “substantially involved in or responsible for” the criminal conduct regardless of relative culpability, Walsh writes, as in cases in which there was corporate-wide direction that was routinely followed.

“DOJ recognizes that the former policy was not practical and potentially could result in a waste of limited government resources,” the post says. “Thus, DOJ now makes clear that investigations should not be delayed merely to collect information about individuals whose involvement was not substantial or not likely to be prosecuted. DoJ encourages companies to engage in dialog with the government, and puts the burden on the company seeking cooperation credit to explain any restrictions it faces from providing full information.”

In civil matters, Walsh says, the revised policy is even more flexible and returns more discretion to the civil attorneys to resolve matters without having to pursue individual liability. The policy now permits DoJ civil attorneys to award gradations of cooperation credit rather than have to select between a binary choice of no credit or full credit. Civil attorneys also are now permitted to consider an individual’s ability to pay in deciding whether to pursue a civil case.

“Overall,” Walsh concludes, “the revised policy leans toward facilitating corporate resolutions more quickly and efficiently, which is a goal both sides of an investigation typically can share.”

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