Drugs

Corporate Whistleblower Center Wants Drug Manufacturing Reports

The Corporate Whistleblower Center, a self-described advocate for whistleblowers in the U.S., is asking drug company employees to report to it instances of unsanitary conditions on a drug manufacturing line. “The reason this is such a big deal,” the center says in a news statement, “is because drugs need to be produced in the cleanest of environments so they do not make an already sick person sicker with a new illness. Because Medicare recipients and average citizens could be at risk, the federal government takes an unclean drug manufacturing facility very seriously.”

There is a lack of federal oversight, the statement says, because federal employees with the responsibility for monitoring drug manufacturing facilities “are over-worked and under-compensated.” The statement points out that whistleblowers could be eligible for a potential reward or compensation for the information.

“Major whistleblowers frequently go to the government thinking they will help,” the center says. “It’s a huge mistake. Do not go to the news media with your whistleblower information. Public revelation of a whistleblower’s information could destroy any prospect for a reward. Do not try to force a pharmaceutical or medical company or individual to come clean if their manufacturing areas are unsanitary. Come to us first, tell us what type of information you have, and if we think it’s sufficient, we will help find the right law firms to assist in advancing your information.”

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