Drugs

Ex-Pharmakon Compliance Director Pleads Guilty to Drug Adulteration

A former compliance director at Indiana compounding pharmacy Pharmakon Pharmaceuticals has pleaded guilty to introducing adulterated drugs into interstate commerce and conspiracy to defraud the U.S. by obstructing FDA functions. Caprice Bearden (Carmel, IN) pleaded guilty in southern Indiana federal court to one count of conspiracy, three misdemeanor counts related to introducing an adulterated drug, and six misdemeanor counts of adulterating drugs (out-of-specification), according to the Justice Department. Sentencing will be set at an unspecified date.

As part of the plea agreement, Bearden acknowledged that she lied, when questioned during 2014 and 2016 FDA inspections, about never recording any out-of-specification drug potency test results. She also attested that she knowingly conspired with another individual to obstruct the agency’s lawful functions.

The government says the conspiracy charge carries a maximum sentence of five years in prison and a fine of $250,000 or twice the gross gain or gross loss from the offense. The distributing an adulterated drug misdemeanor charges each carry a maximum punishment of one year in prison and a fine of $100,000 or twice the gross gain or gross loss from the offense.

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

Read more

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