Drugs

Senate Bill on ‘Mandatory’ FDA Funding a Mistake: Researchers

A Senate bill to move FDA funding from a discretionary to mandatory status would be a mistake, according to researchers from the Mercatus Center at George Mason University. The researchers oppose a Democrat-sponsored bill called the National Biomedical Research Act that would increase funding for targeted biomedical initiatives through a new, reliable funding stream supporting FDA and the National Institutes of Health (see earlier story).

Putting FDA’s budget in a mandatory category would free it from the annual budgetary review by Congressional appropriators, they note, but this would unnecessarily limit the role of Congress. “With its unique ‘power of the purse,’ Congress can set priorities for government by appropriating spending across the vast array of problems and activities that this country faces every year,” they say.

The researchers also contend that instead on throwing more money at the agency, the better solution is decreasing the amount of information that it requires and reviews for drug development. “Two authors suggested changes in the New England Journal of Medicine by redesigning trials to include fewer patients, providing conditional approval of drugs, and requiring postmarketing surveillance,” they say. “The FDA needs more oversight, not less. While mandatory funding may seem like a lifeline, it’s putting the agency at risk by codifying outdated practices. Let’s first review the activity being funded and then determine the best way to pay for it.”

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