FDA Policy/General

Rep. Pallone Blasts RFK Jr. Over Vaccine Changes

Rep. Frank Pallone Jr. (D-NJ) has sharply criticized Health and Human Services Secretary Robert F. Kennedy Jr., accusing him of undermining vaccine access and endangering public health. Pallone’s comments followed a vote by the CDC’s Advisory Committee on Immunization Practices (ACIP), which recently recommended changes that could end insurance coverage requirements for the measles, mumps, rubella, and varicella (MMRV) vaccine in children under age four. The vaccine has been in widespread use since 2009.

On 9/18, the committee voted to recommend standalone chickenpox (varicella) vaccinations for toddlers, rather than the combined MMRV vaccine, due to an increased risk of febrile seizures. The committee also voted to recommend that all pregnant people be tested for hepatitis B and tabled a vote on changes to the hepatitis B vaccine schedule for infants, after vaccine skeptics on the committee raised concerns.

“Secretary Kennedy fired the medical experts who served on the vaccine advisory panel and replaced them with quacks and anti-vaccine activists,” Pallone says. “Now, we are witnessing the fallout of this catastrophic decision. Children will die due to the return of vaccine-preventable diseases as a result of ACIP’s action.”

Paallone, who serves as ranking member of the House Energey and Commerce Committee, says the recommendations could fuel vaccine hesitancy and worsen the nation’s ongoing measles outbreak.

Pallone also urged President Trump to remove Kennedy from his post.

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