Senate Committee Advances HHS Assistant Secretary Nomination
The Senate Health, Education, Labor & Pensions (HELP) Committee voted 12-11 along party lines Thursday to recommend that Brian Christine, MD, be confirmed as assistant secretary for health at HHS, in addition to five other Trump administration nominees. “These nominees are vital to advancing President Trump’s pro-worker, pro-family, pro-patient agenda,” HELP Committee Chair Sen. Bill […]
Major Medical Groups Pushed Out of Role Supporting CDC’s Vaccine Advisors
Multiple healthcare organizations that have historically helped the CDC’s Advisory Committee on Immunization Practices (ACIP) develop vaccine recommendations have been told they can no longer participate in ACIP work groups, leaving the organizations frustrated and worried about what will happen next. “We’re very concerned and disheartened that our organizations are considered ‘special interest groups’ and […]
FDA Panel Votes Against Broad Talazoparib-Enzalutamide Label in Prostate Cancer
An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib (Talzenna) plus enzalutamide (Xtandi) for all patients with metastatic castration-resistant prostate cancer (mCRPC). In an 8-0 vote, members of the Oncologic Drugs Advisory Committee (ODAC) said the available data from the TALAPRO-2 trial do not support a favorable risk-benefit […]
Senate committee approves strengthened shield law for Illinois providers
A Senate committee approved a plan on Wednesday to strengthen protections for providers that offer medication abortion.
Senate Committee approves expanded implicit bias training for healthcare workers in maternal health
A Senate committee passed a proposal Wednesday to expand implicit bias training for healthcare workers who provide maternal health care.
House Committee Wrestles With Lab Test Regulation
Members of a House committee mostly agreed that laboratory-developed tests need more oversight, but were divided Thursday on how best to approach the topic. The issue at hand was a proposed rule from the FDA that would require medical facilities that use lab tests developed in-house to get the tests approved by the FDA, something […]
FDA Advisory Panel Generally Pleased With Pulse Oximetry Clinical Trial Proposal
An FDA advisory committee gave generally high marks to the agency’s latest effort to improve the accuracy of pulse oximeters when used in darker-skinned patients, but raised questions about some of the FDA’s proposed premarket clinical trial guidance for pulse oximeter manufacturers. “I really applaud the efforts of the FDA to reduce disparate bias in […]
Critics Say CDC Advisors’ Infection Control Guidance Isn’t Strong Enough
A CDC advisory committee voted unanimously on Friday to approve draft infection control guidelines, though some critics charge the recommendations don’t go far enough and ignore lessons from the COVID-19 pandemic. At the heart of the controversy is a new “air” category for pathogen transmission, and three levels of air precautions based on how transmissible […]
Potential Cure for Sickle Cell Clears Hurdle for Approval
An FDA advisory committee meeting on Tuesday did nothing to dispel expectations that the investigational agent exagamglogene autotemcel (exa-cel) will become the first approved gene therapy for sickle cell disease (SCD). Members of the Cellular, Tissue, and Gene Therapies Advisory Committee were not asked to vote on the agent’s efficacy or safety, but instead directed […]
Senators Grill NIH Director Nominee on Drug Prices, Gender-Affirming Care
WASHINGTON — Members of the Senate Health, Education, Labor and Pensions Committee questioned Monica Bertagnolli, MD, President Biden’s nominee to lead the National Institutes of Health (NIH), about the high cost of prescription drug prices, the limits of transgender care, and rebuilding faith in the agency, during her confirmation hearing on Wednesday. Biden tapped Bertagnolli, […]