Drugs

OIG Revises Fraud Exclusion Criteria

The HHS Office of Inspector General (OIG) finalized 4/18 a guidance explaining how it will base its decision to exclude drug or medical device companies or their personnel from federal healthcare programs due to False Claims Act suits or investigations. The guidance says a decision to exclude is based on its assessment of future risk to the federal healthcare programs. Attorney Anne Walsh (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the OIG guidance depicts a “risk spectrum,” showing the lowest-risk person as one who self-discloses conduct, which could result in OIG releasing the person from potential exclusion. A person in the middle of the spectrum could avoid exclusion in exchange for agreeing to certain integrity obligations. If OIG deems a person to be in the highest risk category, there would be no way to avoid exclusion.

Under the guidance, Walsh writes, factors the OIG considers relevant are the nature and circumstance of the conduct; conduct during the government’s investigation; significant ameliorative efforts; and history of compliance.

“While a person in the midst of a government investigation under the False Claims Act may be singularly focused on avoiding prosecution,” Walsh concludes, “it is important to keep an eye on factors during the investigation that may result in potential exclusion. The goals are aligned for the most part, but the impact of certain conduct, even actions taken during the investigation, may affect the OIG’s consideration of whether to impose exclusion in the event of a determination of liability.”

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