Drugs

Conference Report on History and Practices of FDA

A 6/2017 conference convened by the Yale Collaboration for Research Integrity and Transparency that brought together concerned academics, patient advocates, legal and medical experts, and leaders from international organizations to talk about serious problems and dysfunctions in how medicines are developed, tested, reviewed, marketed and used, developed seven points on pharmaceutical policy for future consideration:

organized pharmaceutical lobbying has consistently tried to undermine congressional efforts to protect patients from unsafe and ineffective drugs, often with considerable success;
the term “safe and effective” needs to be put in quotes because formal criteria for what constitutes safety have never been established;
FDA, the agency that is expected to protect public health also has a second paymaster to serve—the pharmaceutical industry;
adverse side effects from prescription drugs are very high;
FDA devotes significantly fewer resources and personnel to addressing the massive level of harms, because it gives safety much lower priority than accelerating approval of new drugs;
like the pharma-English term “risk-benefit ratio,” the pharma-English term “off-label” should be avoided because it is too benign and replaced with “unapproved”; and
doctors are no bulwark to patient safety.

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