Drugs

OPDP Says Investigational Remoxy Promoted on Web

The CDER Office of Prescription Drug Promotion (OPDP) says that Web sites operated by Durect Corp. and Pain Therapeutics Inc. are promoting Remoxy ER (oxycodone) extended-release capsules, an investigational new drug, as being safe and effective for the purposes for which it is being investigated. A 9/8 Notice of Violation says that Remoxy ER is a new drug for which no marketing authorization has been granted. Pain Therapeutics resubmitted an NDA in March, the letter says, and statements on the Durect Web site indicate that Remoxy ER is an opioid drug intended for use in long-term pain control.

The notice presents statements from the Web sites that OPDP says suggest that the drug is safe and effective for the purposes for which it is being investigated or otherwise promote the drug. It says that statements such as “long-acting” and “tamper-resistant” are phrased as established facts, suggesting that the product is safe and effective with the characteristics described or otherwise promotes the drug.

“Additionally,” the letter says, “nothing in this presentation, which identifies the product by the trade name under which the NDA indicates Pain Therapeutics intends to commercially market the product, discloses that this product is an investigational new drug, not authorized for marketing in the U.S. for any indication, and the presentation is thereby misleading.”

OPDP says that conclusory statements regarding safety and effectiveness of a drug made while an application for the drug is under review suggest an effort to shape public impressions of the drug in the lead-up to its launch, before FDA evaluation of the product is complete and reflected in approved drug labeling. “Such statements raise considerable public health concerns and may remain probative evidence later when a product is in broad distribution,” it says. “The statements are particularly irresponsible and alarming with respect to an opioid drug product.”

The companies were told to respond with a statement of how they intended to comply with the Federal Food, Drug, and Cosmetic Act and its regulations, including plans for discontinuing materials such as those identified in the letter.

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