Drugs

FDA Speeding Drug Approvals: Pitts

Former FDA associate commissioner Peter Pitts says the agency’s efforts to streamline drug approvals where safety reviews have shown positive results are starting to pay off. Writing in an online column in The Virginia Gazette, Pitts notes that in 2017 FDA approved more than 1,000 generic drugs, 200 more than had ever been approved in a single year previously. And it also approved 46 novel drugs, more than twice as many as in 2016.

“The increase in the number of treatments on the market and the availability of generic medications are providing the competition that is the most effective way to keep drug costs down,” Pitts writes.

He also gives an example of how speeding approvals for branded products improves treatment adherence by lowering costs, citing the decision by Sanofi to start to offer deep discounts on its breakthrough $14,600 cholesterol drug Praluent once FDA had approved other breakthrough cholesterol drugs.

“The dilemma of the drug approval process [balancing speed against safety] hasn’t gone away and probably never will,” Pitts concludes. “But FDA’s determination to make much needed improvements in the processes shows that it can be managed more effectively.”

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