Drugs

Reps Seek Info for ‘Next Generation Cures’

Reps. Donna DeGette (D-CO) and Larry Bucshon (R-IN) are asking stakeholders, interest groups, and healthcare advocates for information on what Congress can do to bring about the next generation of healthcare treatments. “Today we are beginning a new chapter in the legacy of 21st Century Cures,” DeGette and Bucshon said, “and we look forward to hearing ideas on how Congress can help power our research infrastructure and deliver treatments to the patients who need them.”

The 21st Century Cures initiative resulted in the 21st Century Cures Act signed by President Barak Obama in 2016. In 2021, DeGette and former Rep. Fred Upton (R-MI) introduced Cures 2.0 to build upon the 2016 law. DeGette and Bucshon say their letter seeks to build upon the 21st Century Cures initiative and identify what is needed in future legislation to ensure that patients can access life-saving treatments.

The lawmakers say they would like to receive by 8/2 answers to these questions:

whether the policies included in Cures 2.0 that have advanced through legislation or executive action meet the needs that the original Cures 2.0 bill aimed to address;
which elements might be missing that are essential for further progress; and
which additional reforms, support mechanisms, or incentives are needed to enhance or improve the effectiveness of the steps already taken, including any structural reform to agencies, offices, or programs involved.

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