Drugs

Stakeholders Want Compounding Law Fully Funded

Six stakeholder organizations, including industry and public health groups, say they will contact lawmakers and their staffs 4/27 urging funding for full implementation of the new federal drug compounding law. A letter to be sent says that on 4/18 the House Appropriations Committee passed an agricultural spending bill and report that included language on compounding.

The letter will remind lawmakers that a recent FDA draft guidance appropriately provides for traditional pharmacies to compound either upon receipt of a prescription for an individual patient or in anticipation of receiving such a prescription. It also says that Congress recognized, and the guidance reflects, that there are times when providers need supplies of compounded drugs available for “office stock” so that they are available for use in treatment settings.

The groups say that the Drug Quality and Security Act (DQSA) of 2013 was approved after an outbreak of fungal meningitis that sickened more than 700 Americans with 64 fatalities. “To fulfill the promise of the DQSA,” the groups will say in their letter, “FDA must be able to enforce federal prohibitions on compounding without a prescription by pharmacies that do not comply with FDA regulations and do not meet quality standards designated to better protect and ensure patient safety.”

Signing the letter will be the American Public Health Association, Biotechnology Industry Organization, Generic Pharmaceutical Association, Pew Charitable Trusts, Pharmaceutical Research and Manufacturers of America, and Trust for America’s Health.

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