Drugs

Purdue Denies Causing Opioid Crisis

In a legal filing to the Massachusetts Superior Court, Purdue Pharma cites statements from state officials to make the case that it is not solely responsible for causing the state’s opioid crisis. “To be sure, there is an opioid crisis in the Commonwealth,” the document says, “but the responsibility for this crisis cannot, as a matter of law, be tied to one company that manufactures a tiny fraction of the prescription opioids in the Commonwealth.”

The company says that the state’s complaint against it attempts to displace the medical judgments of its own public health experts and those at FDA. It cites state Health Department statements that the opioid crisis was neither created nor caused by Purdue, and instead is the result of a complex issue with a number of contributing factors. Purdue says state officials also have said that the opioid crisis is primarily due to illegal drugs rather than prescription opioids.

The filing says the state’s complaint accuses Purdue of improperly marketing its medications for long-term therapy or at high doses, and notes that FDA has consistently approved those indications. It cites the agency’s response rejecting a 2013 citizen petition seeking to limit opioids to a certain duration and daily dose and declining to issue warnings about the risks of longer therapy and higher doses.

“The Commonwealth’s effort to substitute its judgment over FDA’s and hold Purdue liable for not providing the warnings that FDA, in its expert view of the science, declined to impose cannot stand,” Purdue says.

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