Drugs

Groups Seek Block on Bills for ‘Off-label’ Communications

Public Citizen and 12 other patient advocacy groups are urging House Energy and Commerce Committee members to reject two bills that would “undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use.” In a 6/5 letter, the groups argue that HR 1703 (the Medical Product Communications Act of 2017) and HR 2026 (the Pharmaceutical Information Exchange Act), which are both being considered for inclusion in legislation to reauthorize the agency’s user fee programs, “would threaten patient safety by allowing pharmaceutical and medical device companies to significantly expand the marketing and promotion of their products for unapproved (off-label) uses.”

The letter says it is important that drug and device unapproved uses should undergo “rigorous independent FDA review to ensure that they are safe and effective for all intended uses. “But under HR 1703 and HR 2026, big pharma and the medical device industry would be able to circumvent FDA review. Congress considered similar dangerous legislation during the drafting of the 21st Century Cures Act and wisely rejected it, and we urge Congress to once again do the same.”

HR 1703 and HR 2026 were introduced in March and April, and both have been referred to the Energy and Commerce Committee’s Subcommittee on Health.

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