FDA Policy/General

Republican Platform Pledges to Reform FDA

FDA comes under stringent criticism in the GOP Platform 2016 adopted during the Republican National Convention that concluded in Cleveland, OH 2/22. Pledging to reform the agency, the document says FDA is now threatening “America’s leadership in life sciences R&D and medical innovation” through a “lack of predictability, consistency, transparency and efficiency … that is driving innovation overseas, benefiting foreign, not U.S., patients.”

The platform says FDA “has slowly but relentlessly changed into an agency that more and more puts the public health at risk by delaying, chilling, and killing the development of new devices, drugs and biologics that can promote our lives and our health.” It calls for leadership “that can reform the agency for our century and fix the lack of predictability, consistency, transparency and efficiency at the agency. The FDA needs to return to its traditional emphasis on hard science and approving new breakthrough medicines, rather than divert its attention and consume its resources trying to overregulate electronic health records or vaping.

“We pledge,” it continues, “to restore the FDA to its position as the premier scientific health agency, focused on both promoting and protecting the public health in equal measure, so we can ensure that Americans live longer, healthier lives, that the United States remains the world leader in life sciences and medical innovation, that millions of high-paying, cutting-edge device and drug jobs stay in the United States, that U.S. patients benefit first and most from new devices and drugs, and that the FDA no longer wastes U.S. taxpayer and innovators’ resources through bureaucratic red tape and legal uncertainty. We commend those states that have passed Right to Try legislation, allowing terminally ill patients the right to try investigational medicines not yet approved by the FDA. We urge Congress to pass federal legislation to give all Americans with terminal illnesses the right to try.”

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