Drugs

Resume User Fee Talks: Disease Interests

Some 99 organizations that represent patients with rare diseases and other acute or chronic health conditions are urging congressional leadership to “resume negotiations to develop a comprehensive FDA user fee package.” In an 8/1 letter, the organizations say they are “deeply concerned about the impact that a delay in passage of this legislation will have on FDA’s ability to conduct the timely reviews of critical products that our patients need….” They say other important policies must be considered as part of the user fee reauthorization process and they urge the House and Senate to “quickly develop robust, consensus legislation.”

Citing policy provisions that appear in one chamber’s version of a user fee bill but not the other chamber’s, the groups say “Congress should capitalize on the user fee reauthorization process to consider and enact the additional policies that would have little chance of passage as standalone bills, just as it has every five years since 1992. To pass a ‘clean’ user fee package would be to walk away from an opportunity to make critical improvements in our nation’s system for overseeing medical products. We urge you to immediately work together to blend your respective bills and continue Congress’ longstanding tradition of passing strong, bipartisan FDA legislation to the benefit of all Americans.”

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