Drugs

Stakeholder Suggestions for PDUFA Reauthorization

As FDA moves forward with efforts to reauthorize the Prescription Drug User Fee Act, the Center for Science in the Public Interest (CSPI) asks the agency to consider that congressional appropriations should be the primary source of its funding. In its 7/17 comment letter, CSPI says it supports an FDA that is fully funded to sustain all of its essential operations.

The advocacy organization recognizes that congressional unwillingness to fully fund the agency has led to a greater reliance on user fees to help ensure that scientific review occurs in a timely manner to facilitate patient access to new products.

“We urge the agency to stop any future reductions in force that could jeopardize user fees altogether,” the letter says, “and instead prioritize allocating appropriated funds to core staffing and review activities.”

CPSI also says FDA:

must maintain scientific rigor in its effectiveness standard for drug approvals;
should fund transparency efforts; and
should recommit to clinical trial diversity.

In its comment, the University of Maryland Center for Translational Medicine notes that many chronic diseases still lack FDA-approved disease-modifying therapies. It says that in reauthorizing PDUFA 8, FDA should:

support regulatory flexibility and targeted funding for quantitative approaches;
facilitate and expand access to real-world data; and
strengthen and invest in academic-regulatory partnerships focused on patient-centered innovation.

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