Drugs

Diamantas Tries to Win Back Rare Disease Advocates

In an effort to win back a constituency that has become disenchanted with FDA, acting commissioner Kyle Diamantas met on 6/3 with representatives from several advocacy groups that support people with rare diseases. Reuters reports that although Diamantas heads the agency’s food program and lacks the background traditionally sought in a commissioner, he is being considered along with several others for the position.

The news service quotes Friends of Cancer Research CEO Jeff Allen as saying after the session that the meeting with Diamantas was a “breath of fresh air.” Rare disease advocates had become unhappy with former commissioner Marty Makary over agency actions in rejecting some rare disease treatments and making disparaging comments about them.

In a statement issued before the meeting, Allen said such gatherings demonstrate FDA’s continued commitment to address the real challenges facing the rare disease community and to advance treatments to small patient populations. He later said Diamantas was “exhibiting real leadership by listening to people. It was clear they are repairing the organization, and they are supporters of science and career staff.”

Allen said the agency officials in attendance primarily listened to the rare disease community advocates and did not make any promises for specific actions.

A spokesperson for the Foundation for Angelman Syndrome Therapeutics said that for diseases with small patient populations, regulatory clarity is needed to overcome challenges, including complex histories and limited options for measuring a treatment’s safety and efficacy.

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