Food and Drug Administration Edition
Washington Post: Sunscreen approved by FDA highlights cost of bureaucracy
The Food and Drug Administration approved a new sunscreen ingredient this week for U.S. markets. That shouldn’t be remarkable. Yet this is the first time the agency has done so since 1999, thanks to an 88-year-old law.
The active ingredient, bemotrizinol, was first authorized by European regulators in 1999 and has been a staple in products there ever since, as well as in countries such as Japan and South Korea.
What took them so long? It’s been in use in Europe and Japan for nearly 27 years. I’ve had to buy it off eBay from a vendor who gets it from Japan.
Truthout: FDA “Study” on Mifepristone Revealed Weeks After SCOTUS Blocks Restrictions
“The FDA’s review is a politically motivated farce,” read a statement from Planned Parenthood Action Fund President and CEO Alexis McGill Johnson. “Mifepristone is safe and effective. We know it, the FDA knows it, and the more than 7.5 million people who’ve used mifepristone for abortion and miscarriage care over the past 25 years know it too.”
The FDA should regulate drugs based on safety and efficacy, not partisan politics.
WGHN: How an experimental weight-loss drug is being openly promoted by physicians
Retatrutide isn’t supposed to be everywhere.
Touted as the next generation in the GLP-1 craze, it’s an experimental weight-loss drug that is not authorized outside of clinical trials. The Food and Drug Administration hasn’t reviewed whether it is safe and effective, which is the legal path for prescription drugs to come to market. And yet retatrutide is for sale all over the internet, a phenomenon with no modern precedent.
Perhaps the FDA should speed up their reviews. The results of a Phase 2 trial came out three years ago. The drug discovery period was performed from 2016 to 2019. I’ve used retatrutide in microdoses.
Fox News: FDA delays cost Americans trillions and slow lifesaving drugs, new report says
A new report argues that speeding up Food and Drug Administration reviews could unlock trillions of dollars in economic value and get lifesaving treatments to patients faster.
“It takes about a decade from start to finish to come through FDA,” economist and former acting chairman of the White House Council of Economic Advisers Tomas Philipson told Fox News Digital in an interview. “Most of that time is not spent on safety. Most of it time is spent on effectiveness trials.”
Philipson estimates cutting the review time by one year would boost economic value by $10 trillion and would encourage more innovation and get patients treatments sooner.
Brownstone Institute: FDA Exposed: Hundreds of Drugs Approved without Proof They Work
The US Food and Drug Administration (FDA) has approved hundreds of drugs without proof that they work—and in some cases, despite evidence that they cause harm.
That’s the finding of a blistering two-year investigation by medical journalists Jeanne Lenzer and Shannon Brownlee, published by The Lever.
Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.
Slightly dated study but worrisome, nonetheless.
Fox News: FDA approves fruit-flavored e-cigarettes for the first time in US history
The U.S. Food and Drug Administration on Tuesday authorized the marketing of fruit-flavored e-cigarettes, marking the first time it has authorized fruit-flavored vaping products.
The decision follows a Wall Street Journal report that President Donald Trump had rebuked FDA Commissioner Marty Makary over the weekend for not approving flavored vapes more quickly.
A recent CDC report found that smoking is at an all time low of 9%, while vaping is on the rise and currently stands at 7% of adults. Vaping has increased by about 50% since 2021 from 4.5%. According to a report, in 2021 29% of e-cigarettes users (vapers) also smoked tobacco, 40% were former tobacco users while 30% had never been tobacco users.