Biologics

Congressmen Hit FDA Covid Vaccine Limit

Eight congressional Democrats who were members of the Select Subcommittee on the Coronavirus Pandemic say they are deeply concerned about the FDA decision to limit the approval of updated Covid-19 vaccines.

“We find it perplexing that this new guidance undermines the foundational principles of Operation Warp Speed, a program initiated under the Trump administration, which successfully accelerated the development and distribution of Covid-19 vaccines, saving millions of lives. The current policy appears to disregard the proven benefits of widespread vaccination and may hinder our nation’s ability to respond effectively to future Covid-19 variants,” the legislators say in a statement. “Furthermore, the decision to require extensive clinical trials for low-risk populations could delay the availability of updated vaccines, potentially leaving millions without timely access to necessary protocols.”

The members urge the agency to reconsider the policy change and prioritize a science-based approach that ensures equitable access to Covid-19 vaccines for all Americans, regardless of age or health status “Maintaining robust vaccination efforts is essential to safeguarding public health and preventing future outbreaks,” they conclude.

The statement was issued by Reps. Kweisi Mfume (D-MD), Raul Ruiz (D-CA), Deborah Ross (D-NC), Jamie Raskin (D-MD), Debbie Dingell (D-MI), Ami Bera (D-CA), Robert Garcia (D-CA), and Jill Tokuda (D-IL).

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