Drugs

Upton, DeGette Introduce Cures 2.0

Reps. Fred Upton (R-MI) and Donna DeGette (D-CO) have introduced the 173-page bipartisan Cures 2.0 legislation to change how the U.S. provides care to patients and to speed the delivery of groundbreaking cures, treatments, and innovations. One of the bill’s key provisions is the creation of an Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health that would be charged with finding new cures and treatments to a slate of illnesses that affect millions of U.S. patients such as cancer, diabetes, ALS, and Alzheimer’s.

In a statement (contains links to bill text and summary), Upton and DeGette say that in addition to establishing the new agency, their bill would authorize the full $6.5 billion the administration has requested to run it for the first three years. ARPA-H would be modeled on the Pentagon’s highly successful Defense Advanced Research Projects Agency.

While ARPA-H would be tasked with finding new cures and treatments for some of the world’s most difficult diseases, the representatives say, other provisions in Cure 2.0 would help deliver new cures and treatments to patients sooner and improve the overall level of care Americans are provided.

Some of the bill’s provisions would:

transform how Medicare covers innovative new treatments and technologies to make the new discoveries available to patients sooner;
increase access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program;
provide training and educational programs for at-home caregivers;
require more diversity in clinical trials; and
provide patients with more information about the illness they face and the treatment options available to them to make them a more integral part of the decision-making process.

To address the ongoing Covid-19 pandemic, the bill would require HHS to:

conduct a nationwide study on the implications of a long period of Covid in which patients can have some Covid symptoms that last for months after they recover from the acute phase; and
develop a nationwide testing and vaccine distribution strategy for use in future pandemics.

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

Read more

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