Biologics

Open Bipartisan Probe of RFK Vaccine Plans: Pallone

Rep. Frank Pallone (D-NJ), the top Democrat on the House Energy and Commerce Committee, is calling on the committee to open a bipartisan investigation into HHS secretary Robert F. Kennedy, Jr.’s “recent efforts to disrupt and restrict people’s access to vaccines.” In a letter to committee chairman Brett Guthrie (R-KY), Pallone said Kennedy’s firing of all 17 members of the CDC Advisory Committee on Immunization Practices (ACIP) broke promises he made under oath during his Senate confirmation hearing and is further proof that he intends to use his position at HHS to continue to advance his dangerous pseudo-science agenda.

“These disturbing actions warrant investigation,” Pallone wrote, “and I hope that you will join us in getting answers on behalf of the American people.”

Pallone pointed out that the ACIP’s recommendations go beyond who should receive immunizations and at what age. He said they also ensure immunizations remain accessible and affordable through private insurance and the Vaccines for Children Program. “ACIP-recommended vaccines are to be covered without cost-sharing in Medicare, Medicaid, and private insurance,” Pallone wrote. “Secretary Kennedy’s interventions in the ACIP process will directly threaten Americans’ access to all vaccines, both current and future vaccines in the pipeline. We must prevent this administration from undermining ACIP and persistently spreading anti-vaccine conspiracy theories that threaten decades of public health progress and put lives of Americans, including pregnant women and children, at risk.”

In addition to calling for a hearing with Kennedy specifically focused on his actions “to undermine ACIP’s long history of making scientific, evidence-based recommendations on vaccines,” Pallone also asked for an investigation into Kennedy’s decision-making process with a request for this information:

documentation and rationale provided to the 17 ACIP members before their termination;
contemporaneous documentation and substantiation of what appear to be baseless accusations leveled by Secretary Kennedy against the dismissed ACIP members; and
briefings as well as documents from HHS related to the process used to select the eight new ACIP members and all documentation relating to the vetting of these new ACIP members.

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