FDA Policy/General

Purdue Sentencing Sets $5.3 Billion in Criminal Penalties

Purdue Pharma was sentenced 4/28 in federal court in Newark, NJ, to pay more than $5 billion in criminal penalties for its role in the U.S. opioid epidemic. The penalties include a $3.544 billion criminal fine and $2 billion in forfeiture, though up to $1.775 billion of the forfeiture may be credited depending on the outcome of the company’s ongoing bankruptcy proceedings, according to a Justice Department release.

According to court documents, Purdue illegally marketed its opioid products between 2007 and 2017, targeting prescribers the company had reason to believe were issuing prescriptions without legitimate medical purpose. Prosecutors said the company also misled the Drug Enforcement Administration about its efforts to prevent drug diversion and used those representations to seek higher manufacturing quotas.

The government further alleges that Purdue paid illegal kickbacks to healthcare providers through speaker programs and an electronic health records platform to encourage increased prescribing of its opioid medications.

In 2020, Purdue pleaded guilty to a three-count felony information charging it with one count of a dual-object conspiracy to defraud the U.S. and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute.

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