FDA Policy/General

Public Citizen Announces Death of Sidney Wolfe

Public Citizen says Dr. Sidney Wolfe, the founder of the Health Research Group in 1971, which later that year became part of Public Citizen, died 1/1 at the age of 86. “Sid invented a new approach of research-based advocacy to get dangerous drugs and devices off the market, with new protections for worker health and safety, address donor misconduct, challenge FDA, and hold pharmaceutical companies accountable,” said Public Citizen president Robert Weissman in a statement.

The statement lists these among Wolfe’s accomplishments:

documented weakening standards at FDA following the passage of the first Prescription Drug User Fee Act, making drug companies a major FDA funding source;
testified before hundreds of FDA advisory committees urging against approval of dangerous drugs and devices and for limited use or strong Warning labels of others, with substantial influence over countless decisions;
helped to force 28 dangerous medications off the market, limiting the use of 10 more and adding Warnings to dozens of others;
pushed the Occupational Health and Safety Administration to set more than a dozen worker-protective health standards;
won a ban of red dye #2, obtained Warning labels about Reye’s syndrome on the side of aspirin bottles, and helped impose restrictions on silicone breast implants;
sold 2.5 million copies of the book Worst Pills, Best Pills;
won earlier public access to safety and efficacy information for products being considered for approval by FDA, enabling more effective advocacy by consumer advocates; and
advocated for decades against drug company marketing of dangerous opioids and demanded accountability for the drug companies and the corporate CEOs who fueled the deadly opioid addiction epidemic.

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