Drugs

No Marketing of Same Rx and OTC Drugs: Reps

Reps. Dan Crenshaw (R-TX), Robert Latta (R-OH), and Debbie Dingell (D-MI) say FDA should not permit simultaneous marketing of the same prescription and over-the-counter (OTC) drug product involved in an Rx-to-OTC switch. In a 9/6 letter to CDER director Patrizia Cavazzoni, the representatives reference a recent agency proposed rule on drug switches.

“While we support FDA’s efforts to improve public health through increased access to nonprescription drugs,” they write, “we are concerned one key element of the rule may create a disincentive to switch medicines to nonprescription status, thus undermining public health goals. The reason for this concern is the proposed concept of simultaneous marketing of both prescription and nonprescription versions of the same drug.”

The representatives argue that simultaneous marketing of the same Rx and OTC drug “would ultimately limit rather than expand access for underserved communities, while also undermining the rule’s anticipated favorable economic impacts. For decades, Rx-to-OTC switches have proven to increase access to safe and effective self-treatment options, and we should be extremely cautious of any actions that could disincentivize manufacturers from pursuing this pathway that benefits consumers and the healthcare system.”

They call on Cavazzoni to remove the simultaneous marketing provision from the proposed rule.

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