Drugs

Reps Want Office-Use Drug Compounding

Some 65 members of the House of Representatives from both parties are urging FDA to rescind its decision restricting state-licensed pharmacies from compounding prescription drugs for healthcare providers to use in their offices. The move is being led by Reps. Chris Stewart (R-UT) and Earl Carter (R-GA).

In a letter to FDA commissioner Scott Gottlieb, the lawmakers say the agency ignored a specific congressional directive when it issued a 12/29/16 guidance prohibiting office-use compounding by smaller traditional compounding pharmacies, known as 503A compounding pharmacies.

“The policies finalized in this guidance are contrary to the plain language of Section 503A as amended by the Drug Quality and Security Act and ignore clear, bipartisan, bicameral congressional intent expressed during passage of the bill,” the letter says. “FDA has unfortunately chosen to ignore broad and diverse stakeholder input, multiple congressional letters from both chambers, and clear directives in the House report accompanying the FY2016 FDA appropriations legislation. More importantly, FDA’s misinterpretation of the law and related enforcement actions against pharmacies are jeopardizing patients’ access to critical compounded medications.”

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