Drugs

Former Pharmatech CEO Gets 37 Months in Jail

A Florida federal judge has sentenced former Pharmatech CEO Raidel Figueroa to 37 months in federal prison for lying to FDA and allowing contaminated products to be shipped to pediatric hospitals. A Department of Justice (DoJ) news release says Pharmatech manufactured and distributed the laxative Diocto Liquid between 2016 and 2017. FDA inspected Pharmatech in Broward County, FL, in 2016 as part of a larger investigation into an outbreak of Burkholderia cepacia infections and reported that samples from the company’s water system tested positive for B. cepacia.

The DoJ says that when FDA again inspected Pharmatech in 2017 and asked Figueroa to disclose all products the company had manufactured since a reported water system upgrade, he lied to the investigators by knowingly excluding Diocto Liquid from the product distribution list. He also reportedly told the agency the water system had met “acceptance criteria,” which DoJ says also was not true.

Multiple B. cepacia infections at several children’s hospitals were traced to bottles of Diocto Liquid that Pharmatech had distributed to the facilities.

Figueroa pled guilty in June to conspiring to defraud FDA, falsifying records in an FDA investigation, obstructing proceedings before FDA, and distributing adulterated drugs.

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