Drugs

Makary Outlines Push to Modernize Drug Reviews

FDA commissioner Marty Makary says he wants to speed up the nation’s drug approval process without compromising safety, describing his plans to “modernize” the agency in a wide-ranging interview with CNN’s Sanjay Gupta. Speaking in Atlanta last week during a CEO listening tour, Makary told Gupta that his focus is on eliminating bureaucratic delays and making better use of real-time data during clinical trials. “When an application sits on a desk for three months, you’re not increasing the safety evaluation by just adding time,” Makary said. “We can run more continuous trials using modern technology and bring regulators together in real-time reviews. We can get decisions out in weeks, which is unprecedented at the FDA.”

Makary emphasized the need for balance between individual patient care and public health. He argued that the agency can review data more efficiently while still upholding “the same high standards of safety,” noting that idle time during long clinical trials could instead be used to complete much of the review process.

The commissioner also addressed the agency’s role in ongoing national debates around autism, Tylenol, vaccines, and abortion medications. On the surge in autism diagnoses, Makary said the agency is investigating possible mechanisms such as autoimmune responses and mitochondrial dysfunction. He pointed to clinical interest in Leucovorin, a decades-old B-vitamin treatment, which some doctors have reported as beneficial in children with certain biomarkers. NIH recently announced $50 million in new funding to study the therapy.

Asked about vaccine safety, Makary rejected claims of a definitive link to autism. “I don’t think so,” he said when Gupta raised the question. He cautioned, however, that absolutist rhetoric on either side can undermine trust. “No medicine is 1,000% safe. The absolutism around some of this stuff creates mistrust,” he said, urging a more “humble and honest” approach.

He added that restoring public trust at FDA requires a return to civil, evidence-based debate. “Science is a process of asking questions and a healthy discourse among experts. If we show more humility, I think we can win over some more public trust.”

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

Read more

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