Drugs

Columnist Wants FDA Drug Innovation Support

An online RealClear Health column by research assistant Jordan Reimschisel calls on FDA to increase support for drug innovation as its primary goal. The column says the goal that policy makers like Congress should pursue is to “create an environment in which innovation and entrepreneurship can thrive with as few barriers as possible…. The default attitude toward innovation should be to allow it to proceed unencumbered by prohibitive regulation unless it poses an imminent, catastrophic, and irreversible harm to society.”

The author says that proposals that lessen the number of steps needed to bring new drugs to market will lower the cost and allow more firms to participate in the process. On the other hand, he says, proposals that erect more barriers and regulatory checkpoints generally increase costs, stall innovation, and reduce patient access.

“Ultimately,” Reimschisel writes, “Congress is not considering policies that go far enough toward encouraging innovation in medicine. FDA has more foundational problems that need to be addressed. The agency has become too risk averse and prone to extremely restrictive rules. Changing the focus of FDA from drug and device approval to risk education will arm patients with information and allow them to make their own judgments about risk/reward trade-offs.”

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