Drugs

New Repackaging Rules May Violate Current Regs: Comments

Four groups representing those working in long-term care (LTC) pharmaceutical settings say that an FDA draft guidance on repackaging could impose inappropriate new requirements that may conflict with existing regulation. Oblivious to the voluntary nature of FDA guidances, a statement from the Senior Care Pharmacy Coalition (SCPC), American Society of Consultant Pharmacists, American Health Care Association, and the National Center for Assisted Living (includes link to letter to FDA) says that the agency “must recognize the demands of other regulators that control LTC for our nation’s vulnerable seniors, and avoid imposing inappropriate new burdens on complex and already well-controlled systems. FDA must also recognize that the practice patterns of LTC pharmacies are truly those of a professional pharmacy, not commercial product manufacturers, wholesalers, or repackagers.”

SCPC president Alan Rosenbloom says in the statement that “FDA is contemplating a guidance document that would needlessly limit or require outsourcing of packaging activities that currently occur within LTC pharmacies, driving up cost and waste in the LTC system and potentially risking care for patients. For example, before dispensing medication many LTC pharmacies currently pre-package drug products from bulk into individual blister cards. FDA’s proposed guidance would arbitrarily limit the quantity that pharmacies could package, even if the pharmacy had justification for the quantity based on its dispensing patterns and predictions.”

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