Drugs

Hahn Updates FDA Actions on CBD

FDA commissioner Stephen Hahn says the agency is taking additional steps to educate consumers and healthcare providers about cannabidiol (CBD) products and to obtain additional data to help evaluate those products. In a statement released online 3/5, Hahn says the agency recently updated the public on concerns about potential harms from CBD products, including potential liver injury, interactions with other drugs, and male reproductive toxicity, as well as side effects such as drowsiness.

“We will continue to expand our educational efforts on this front,” he writes. “This includes consumers broadly, specific populations where there are additional, important health considerations, as well as healthcare professionals who must understand these risks when talking to their patients.”

FDA also is exploring ways to address gaps in data as quickly as possible, Hahn says. “This includes encouraging, facilitating, and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency, and identifying opportunities to further collaborate with our federal partners … on this important issue.”

Hahn says FDA will reopen the public docket established for a 5/2019 public hearing on CBD because it provides “a valuable conduit for submission of scientific data on CBD to the agency.”

Finally, he reports that “as we work to educate the public and close the knowledge gaps to further guide our approach to CBD products, we will continue to monitor the marketplace and take appropriate action against unlawful CBD products that pose a risk of harm to the public…. We are currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement 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