Drugs

Compounding Pharmacists See FDA ’Overreach’

International Academy of Compounding Pharmacists executive vice president Scott Brunner says FDA “has overreached in implementing provisions” of the Drug Quality and Security Act of 2013, “all but halting common compounding practices that have been safely performed for years and on which patients with legitimate need for compounded medications rely.” In a Stat post, Brunner says FDA has acted by circumventing the Administrative Procedure Act and instead issuing guidance documents to implement its policies.

According to the post, FDA has acted on its own authority and outside of congressional directives, as well as without heeding input from pharmacist, physician, and patient groups, to redefine terms such as “dispense” and “distribute” in ways that restrict what has been a basic function of pharmacists for decades.

“These restrictions, in turn, are likely to cause difficulty for patients in accessing and affording the medications they need,” Brunner writes.

He says FDA could fix many of the problems it has created without formal congressional action by listening to and working with state boards of pharmacy as well as pharmacist, prescriber, and patient groups to find middle ground through a regulatory framework that respects the primary role of states in regulating compounding pharmacies while assuring practices that thoroughly protect patients who rely on compounded drugs.

If FDA doesn’t change his approach, Brunner says, Congress may need to get involved and move bipartisan legislation, the Preserving Patient Access to Compounded Medications Act (H.R. 1959).

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