Drugs

FDA Sued Over Absent Petition Response

Pharmaceutical Manufacturing Research Services (PMRS), a contract drug manufacturer, is suing FDA in Pennsylvania federal court seeking an order requiring the agency to respond “promptly” to the company’s petition asking FDA not to approve Inspiron Delivery Services’ Roxybond (oxycodone hydrochloride) tablets, pending the agency’s substantive responses to two pending PMRS petitions raising issues about the Inspiron drug. The court complaint says that nearly three months after submitting its time-sensitive petition, “PMRS still has not received any substantive response and yet another mislabeled and dangerous opioid is poised to enter the market despite the issues and science presented to FDA in PMRS’ various submissions.”

PMRS says it is not asking for the court to dictate what FDA’s response ought to be. Rather, it says, it is simply asking the court to exercise its authority under the Administrative Procedures Act and other laws to compel FDA to provide the response it owes PMRS within 30 days. The company also asks the court for an injunction to stay the effective date of the Roxybond approval until FDA responds to its petition for a stay.

“FDA’s unreasonable delay warrants this court’s involvement because it presents serious risks to the health and well-being of the American public in light of the ongoing and devastating opioid epidemic, as well as potentially irreparable economic and competitive harm to PMRS,” the court filing says. “PMRS’ citizen petitions, as well as its public comments at numerous FDA meetings in recent years, highlighted several serious flaws in FDA’s process for evaluating and approving opioids, and sought to engage FDA in connection with the agency’s role in stemming the opioid epidemic plaguing this nation.”

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