Drugs

Continue OTC Monograph Reform: Health Groups

Eight public health advocacy organizations are asking FDA acting commissioner Norman Sharpless to continue to reform the monograph system for over-the-counter (OTC) drugs. In a 4/24 letter, the groups (American Academy of Allergy, Asthma, and Immunology; American Academy of Pediatrics; American Public Health Association; Consumer Healthcare Products Association; March of Dimes; National Association of County and City Health Officials; the Pew Charitable Trusts; and Society for Maternal-Fetal Medicine) say that CDER director Janet Woodcock and former commissioner Scott Gottlieb “worked successfully with both chambers of Congress to develop policy to modernize this system and to address this urgent public health need through the bipartisan, bicameral Over the Counter Drug Safety, Innovation, and Reform Act.”

The groups urge FDA to continue working with congressional leaders toward final passage and implementation of the legislation. Reform of the monograph system is long overdue, the groups write, and the legislation would streamline regulation for these drugs, transitioning away from the current rulemaking process and authorizing use of administrative orders.

The letter says that through a “modest user fee,” the agency would have resources to oversee the market and to clear the substantial backlog of unfinished monographs, providing patients and consumers with greater confidence in the safety of OTC products and more choice among products that might best meet their health needs.

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