FDA Policy/General

Bill Would Create New Health Advanced Research Agency

Rep. Diana DeGette (D-CO) says she and Rep. Fred Upton (R-MI) have drafted wording to be included in a circulating Cures 2.0 bill that would, among other things, create an Advanced Research Projects Agency for Health (ARPA-H) that is sought by President Joe Biden to develop cures for cancer, Alzheimer’s and other difficult diseases. In a statement (includes links to a section-by-section bill summary and a copy of the full Cures 2.0 discussion draft), DeGette says her proposal would authorize the more than $6.5 billion the White House says is needed to run the new agency.

The legislative language coincides with the 6/22 release of a detailed White House concept paper on the new agency that was published in Science Magazine.

“The federal government has amazing resources at its disposal,” DeGette and Upton say, “and now is the time to put the full weight of those resources to use to cure some of the world’s most devastating diseases such as cancer, diabetes, Alzheimer’s, and more. Developing and delivering new lifesaving cures is a mission that must unite all of us.”

The legislators say that, unlike other federally-funded biomedical research programs, ARPA-H would be run by a relatively small number of program managers who would be given a much higher degree of autonomy to choose which projects to fund, allowing them to pursue high-risk, high-reward projects that other agencies would likely shy away from.

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