Drugs

No Change in Risk/Benefit Analysis: Cavazzoni

CDER director Patrizia Cavazzoni says areas of agency flexibility developed during the Covid-19 pandemic do not include changes to how the balance between a drug’s risks and benefits is determined. Responding to a question during a wide-ranging WebMD video interview, she said CDER continues to ensure that any drug’s benefits outweigh its risks.

She noted that emergency use authorizations have different standards than full approvals, and that may account for some observers believing that the approval calculus has changed.

In terms of Covid therapeutics, she said, the analysis is now based on the fact that some treatments are available and that’s different than when no treatments were available.

Asked whether the flexibility the agency has shown during the pandemic will continue, Cavazzoni said FDA is in the midst of internal discussions on that topic. She said the agency is committed to maintaining flexibility in drug development and clinical trials, including through the possibility of decentralized trials and digital health.

Interviewer John Whyte noted that during 2020 FDA approved the second-highest number of drugs in 20 years, allowing Cavazzoni to “brag” about the commitment of the staff in doing all the traditional work facing the Center while also combatting a pandemic.

In response to a question about health equity and clinical trial diversity, she said sponsors and FDA still have progress to make in ensuring that clinical trials reflect the population that will use a drug. She pointed out that because Covid-19 has a disproportionate impact on minority populations, it was a good object lesson on the need for diversity in clinical trials and FDA worked with sponsors to achieve that for Covid treatments. She said the agency is considering additional guidance on trial diversity.

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