Drugs

GAO Asked to Reevaluate FDA Foreign Drug Oversight

Bipartisan leaders of the House Energy and Commerce Committee are asking the Government Accountability Office (GAO) to revisit its past evaluations of FDA’s oversight of foreign drug plants. In a 12/18/15 letter, the representatives say that while FDA has implemented many changes since 2010, “we are concerned about the agency’s actual progress in meeting the demands of a global pharmaceutical supply chain. In particular, there is a history over two decades in both China and India of counterfeiting, adulteration, substandard manufacturing, and data falsification in drug manufacturing.”

The congressmen say that despite this experience with the two countries, they are concerned that there is still inadequate oversight and an unequal playing field compared to U.S. manufacturers that are subjected to more frequent and rigorous inspections.

The letter asks GAO to assess FDA’s activities and accomplishments in foreign drug inspections and operation of its foreign offices. The letter asks numerous specific questions for each of the two areas.

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