FDA Policy/General

Groups Oppose McMurry-Heath as FDA Commissioner

Responding to media reports that Biotechnology Innovation Organization (BIO) CEO Michelle McMurry-Heath is one of President Joe Biden’s leading candidates to be named FDA commissioner, Public Citizen and 25 other groups are voicing their “strong opposition.” In a 10/12 letter to Biden, the groups say the commissioner should be “someone with demonstrated independence from Big Pharma. Serving as head of a Big Pharma trade association is per se disqualifying for the position of FDA commissioner.”

The letter says that in her position at BIO, McMurry-Heath has represented the interests of several hundred pharmaceutical and biotechnology companies regulated by FDA and has opposed the administration’s efforts to lower drug prices and endorsed other policies contrary to the public interest.

“Individuals who currently or have recently worked as pharmaceutical industry executives, served on drug corporation boards of directors, held positions at organizations that greatly relied on industry funding, or lobbied for or otherwise meaningfully represented the industry cannot provide that essential independence,” the letter says. “The country desperately needs an FDA commissioner who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical device industries has grown ever cozier, resulting in regulatory capture of the agency by industry. The next FDA commissioner must be someone who has been dedicated to advancing public health and unquestionably will place the public interest ahead of the interests of FDA-regulated industries. Dr. McMurry-Health is not that person.”

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