FDA Policy/General

Commerce Committee Probes FDA Internal Disputes

The U.S. House Energy and Commerce Committee’s Republican leadership is investigating FDA’s handling of internal scientific disagreements related to regulatory decisions. In a 1/3 letter to agency commissioner Robert Califf, Committee leaders took issue with the 2021 departure of CBER Office of Vaccines Research and Review (OVRR) director Marion Gruber and her deputy Philip Krause, who both left FDA in protest over how the agency and Biden Administration were handling Covid-19 vaccine reviews and approvals (see earlier story).

In the letter, the leaders note that neither Gruber nor Krause believed there was enough data to justify offering booster shots at the time, and both felt pressure from the Biden Administration to authorize the shots quickly. “It is unknown whether the FDA dispute resolution process was used, and if not, why not,” they write. “We are concerned that the FDA may have retaliated against career FDA regulators who were viewed as insufficiently cooperative with the Biden administration’s agenda.”

The Committee’s letter seeks updated information on how FDA is managing internal scientific disagreements, and it requests the following:

Copies of the administrative files related to all internal scientific disagreements at FDA since 1/1/2018.
All documents since 1/1/2018 related to the Office of Chief Scientist’s handling of appeals of internal scientific disagreements.
All documents related to the scientific disagreement over coronavirus booster vaccination during 2021.
All documents since 1/1/2018 related to instances where decision-making authority was removed from FDA officials involved in regulatory decisions.

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