FDA Policy/General

Put Priority on Data/Technology and Staff: FDA Alliance

The Alliance for a Stronger FDA says that commissioner Robert Califf’s first priorities should focus on “renewed attention” to data and technology modernization at the agency, and “vigorous support for FDA staff who have been working non-stop for two years without any break.” These were recommendations the Alliance offered to media requests earlier in the week as the Senate prepared to move his confirmation vote to the Senate floor, Alliance executive director Steven Grossman noted in the group’s weekly commentary.

Due to the group’s broad-based membership that has “diverse interests,” the Alliance stays away from specifically endorsing any commissioner candidate that is nominated, Grossman said. “Instead, our consistent position over the last 15 years has been to urge ‘quick nomination and quick confirmation.’”

The fact that it has been over a year without a confirmed FDA head is not unusual, he said, adding: “The first commissioner to be confirmed was Dr. Kessler in 1990. Of the eight commissioners since his time, half were sworn in more than a year after their predecessor left the agency (Drs. Henney, McClellan, Crawford, and von Eschenbach). This is an institutional problem that should be addressed in the future.”

Asked whether the Alliance was concerned that the Senate narrowly confirmed Califf and whether there are any consequences because of that, the Alliance responded: “There is no such thing as ‘barely confirmed.’ When Dr. Califf is sworn-in, he will be the commissioner of FDA with all of the authorities and responsibilities of the office.”

Overall, the Alliance is congratulating Califf on his return to the agency, according to Grossman. “The entire stakeholder community looks forward to working with you again,” he said. “Please be the champion for FDA resources — staff and funding — that you were during your previous term. Special thanks to Dr. Woodcock for running a steady ship over the last 13 months, for her career-long devotion to the FDA, and for continuing to serve the public by taking on the role of principal deputy commissioner. I believe that the Califf/Woodcock team provides a combination of agency knowledge and leadership skills that is incredibly promising for the American people and for us as stakeholders.”

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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’

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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

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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