All posts tagged: FDA

Trump Says US FDA Commissioner Makary Is Out

Trump Says US FDA Commissioner Makary Is Out

Published by Sam Flores

By Yasmeen Abutaleb and Ahmed Aboulenein WASHINGTON, May 12 (Reuters) – U.S. FDA Commissioner Marty Makary resigned, President Donald Trump said on Tuesday, after weeks ⁠of ⁠clashing with top White House and health advisers and drawing scrutiny for ⁠a series of controversial agency decisions, according to several people familiar with internal dynamics. Food and Drug Administration Deputy Commissioner for Food Kyle Diamantas will lead the agency in an ​acting capacity, Trump said. Politico first reported the development. “Marty is a terrific guy, but he’s going to go on and he’s going to lead a good life. He was having some difficulty,” Trump told reporters. “The assistant, the deputy is taking over temporarily until we find someone.” Makary resigned ‌effective Tuesday via a text message to Trump, touting his moves ‌to speed up some drug review times, support research into psychedelic drugs and broaden use of menopause hormone therapies. “It’s been the honor of a lifetime to serve as your FDA Commissioner. I am forever grateful,” he wrote in the message, which Trump shared on Truth …

A Political End for an Unusually Political FDA Commissioner

A Political End for an Unusually Political FDA Commissioner

Published by José Betancourt

Marty Makary, the Johns Hopkins surgeon who has led the FDA for the past year, is facing criticism from all sides. Vaping advocates are angry because of the FDA’s slow progress on green-lighting their products. Pro-life groups have called for Makary’s firing because he has not been tough enough on abortion. Current and former FDA officials have repeatedly warned that the agency is in turmoil. Even drug companies, typically cautious about criticizing regulators, have raised concerns about the state of the agency. Donald Trump has now reportedly signed off on a plan to fire Makary—although when, exactly, that axe might fall is unclear. On Friday evening, the president told reporters gathered at the White House that he knew nothing about Makary’s future. Traditionally, FDA commissioners have been less dramatic figures; they have approached their role as steward of an organization whose strength stems from its independence. The logic of that position is simple: Putting a drug on the market simply because of a commissioner’s or a president’s preference, or burying politically inconvenient research, doesn’t inspire …

Trump Says He’s Not Replacing FDA Chief Makary

Trump Says He’s Not Replacing FDA Chief Makary

Published by Jenni Sidey

Authored by Aldgra Fredly via The Epoch Times, President Donald Trump said on May 8 that he has no plans to replace Marty Makary as commissioner of the U.S. Food and Drug Administration (FDA). When asked by reporters outside the White House about Makary, Trump responded: “Nothing much, he’s doing fine,” without elaborating further. Trump said he had seen reports suggesting the administration was planning to remove Makary from his role leading the FDA, but added that he knows “nothing about it.” The president also rejected the notion that he would hire someone new to replace Makary. Amid the media speculation, White House spokesman Kush Desai said in a statement to multiple news outlets that Trump “has assembled the most experienced and talented administration in history.” Several media outlets, citing unnamed sources, on May 8 stated that the president intends to remove Makary after controversies surrounding abortion drug mifepristone. A federal appeals court on May 1 blocked the mailing of mifepristone until the FDA can ensure the abortion drug is “safe and effective” for use …

Trump Plans to Fire US FDA Chief Makary, Sources Say

Trump Plans to Fire US FDA Chief Makary, Sources Say

Published by Sam Flores

By Yasmeen Abutaleb and Jarrett Renshaw WASHINGTON, May 8 (Reuters) – The White House signed off on a plan to fire U.S. ⁠Food ⁠and Drug Administration Commissioner Marty Makary, according to sources familiar with ⁠the matter, in what could be the next leadership change within the federal health department. The Wall Street Journal earlier on Friday first reported that President Donald ​Trump planned to fire Makary. Two of the sources, who are advisers to the White House, said a decision was not final. A third source close to the White House said they were told the FDA commissioner “is done” and that Trump ‌signed off. The White House did not defend Makary as reports ‌emerged of his imminent ouster, but at least publicly, Trump has not said he would replace him. “No, no,” Trump said on Friday evening when a reporter asked whether he would bring in someone new to lead the FDA. Top officials ⁠have been discussing possible replacements ⁠for Makary in recent days, according to the three people. But they cautioned the decision …

FDA announces first approval of fruit-flavored e-cigarettes for adults

FDA announces first approval of fruit-flavored e-cigarettes for adults

Published by Sam Flores

Flavored disposable e-cigarettes are seen in this illustration taken July 18, 2022. Shannon Stapleton | Reuters The Food and Drug Administration on Tuesday announced its first authorization of fruit-flavored electronic cigarettes intended for adult smokers, a major policy shift that comes after months of appeals to President Donald Trump from the vaping industry. The decision is certain to be opposed by health groups and parent organizations that have long pointed to flavors as the driver behind underage vaping in the U.S. But the federal action comes as teen vaping rates have dropped to a 10-year low and manufacturers have pushed the Republican administration to loosen restrictions on their products. Vaping companies have long made the case that their products can help blunt the toll of smoking among adults, which is blamed for 480,000 U.S. deaths annually due to cancer, lung disease and heart disease. The battery-powered devices have been sold in the U.S. since 2007, but their potential benefits have been overshadowed for years by uptake among middle and high school students. The newly authorized …

FDA finds low-level chemical contamination in US baby formula

FDA finds low-level chemical contamination in US baby formula

Published by skeptic

More than 300 products were tested as part of a nationwide safety review targeting toxic metals, pesticides, PFAS chemicals, and other contaminants. The results showed that most baby formula samples either contained no detectable contaminants or only trace amounts that fell within existing safety expectations. Federal officials said the findings reinforce confidence in the US baby formula supply, although the agency plans to continue testing and push manufacturers to reduce contaminant levels further. The large-scale review was conducted under the FDA’s Operation Stork Speed initiative alongside its Closer to Zero programme, both designed to strengthen oversight of infant nutrition products following years of scrutiny over supply shortages and food safety concerns. Largest-ever FDA baby formula investigation The FDA said the project generated more than 120,000 data points after scientists analysed powdered, liquid, and concentrated baby formula products purchased from retailers across the United States. Laboratories screened products for a wide range of substances linked to potential chemical contamination, including lead, mercury, cadmium, arsenic, glyphosate, glufosinate, PFAS compounds, and phthalates. Health and Human Services Secretary Robert …

A brain implant to treat depression gets FDA greenlight to start trials

A brain implant to treat depression gets FDA greenlight to start trials

Published by Jenni Sidey

Get the Popular Science daily newsletter💡 Breakthroughs, discoveries, and DIY tips sent six days a week. Earlier this week, the United States Food and Drug Administration (FDA) approved a human trial for a blueberry-sized brain implant intended to target treatment-resistant depression. The brain-computer interface (BCI) developed by Houston-based startup Motif Neurotech aims to deliver electrical stimulation to activate parts of the brain’s central executive network that are inactive in people with major depressive disorder. If successful, it would make this the first example of a BCI used to treat clinical depression. “The goal for this technology is that it would be the mental health equivalent of a continuous glucose monitor for diabetes,” Motif CEO and co-founder Jacob Robinson, said in an e-mailed statement. The Motif implant, known as DOT, sits in the bone over the brain region well-established as a target for depression treatment. The DOT, approximately the size of a blueberry, is wirelessly powered and designed to be implanted in a 20-minute outpatient procedure. Image: Motif Neurotech via Businesswire. Treating depression with wireless stimulation …

US FDA Taps Szarama as Acting Head of Vaccine Unit

US FDA Taps Szarama as Acting Head of Vaccine Unit

Published by Sam Flores

May 1 (Reuters) – The U.S. Food ⁠and ⁠Drug Administration has named ⁠Katherine Szarama as the acting director of its vaccines ​and biologics unit, a Health and Human Services official told Reuters on Friday, replacing ‌Vinay Prasad, whose turbulent ‌tenure came to an end this week. The appointment comes days after FDA ⁠Commissioner ⁠Marty Makary said no decision had been reached on Prasad’s permanent ​successor and that he expected an announcement “in the coming weeks.” Szarama will lead the Center for Biologics Evaluation and Research (CBER), which regulates vaccines, gene therapies and the blood ​supply. Prasad left the agency after a term marked by controversy, including ⁠several high-profile ⁠decisions on rare disease ⁠drugs ​and vaccines. The news was first reported by Politico. Before joining the agency, Prasad, an ​oncologist, was known for ⁠his vocal criticism of U.S. drug and vaccine policies, especially concerning COVID-19 mandates. His time at CBER was marked by repeated clashes, most notably the FDA’s rejection of a Huntington’s disease gene therapy from Dutch drug developer UniQure. The ⁠U.S. drug regulator called …