Drugs

No FDA Funding for RADAR: Public Citizen

Public Citizen is calling on FDA to change its plan to research the misuse of pharmaceutical products and other substances through an agency-funded program that may use the Researched Abuse, Diversion and Addiction-Related Surveillance program (RADARS). The Public Citizen comment letter asks the agency to clarify who its contractor will be and what funding will be involved.

“We are concerned that the proposed data collection plan aims to use FDA resources to support RADARS, a drug abuse and dependence monitoring organization that has long been excessively influenced by Purdue Pharmaceuticals and other opioid manufacturers, at the expense of the public’s health,” the letter says. “RADARS is an organization that was formed by Purdue Pharmaceuticals and has continued to support questionable lobbying efforts by the opioid industry. We are concerned that RADARS seems to have been selected as a single-source beneficiary of this FDA research funding.”

Public Citizen says it recommends that FDA publicly revise this research database development effort so that there is no funding or direct collaboration with RADARS. Such industry engagement in this regulatory surveillance effort would be bad for public health it says.

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