“The Food and Drug Administration plans to approve a new use for the generic drug leucovorin in the coming weeks to treat kids with “cerebral folate deficiency and autistic symptoms,” according to a POLITICO Magazine opinion piece by federal health leaders published on Monday.
The officials — FDA Commissioner Marty Makary, National Institutes for Health Director Jay Bhattacharya and Centers for Medicare and Medicaid Services Administrator Mehmet Oz — pointed to research they say suggests leucovorin, also known as folinic acid, may help children who are deficient in folate, a vitamin. They said there was evidence leucovorin, which is currently used to treat cancer and anemia patients, can help children with autism improve their verbal communication. But they emphasized in the opinion piece that the drug “is not a cure for autism.”
While scientists say leucovorin, a form of vitamin B, could be promising for a subset of autism patients, they cautioned that the current data is limited and the drug needs more research.”
“Many more families might have benefited over the past couple of decades from similar treatments pioneered a quarter of a century ago, except that handwringing bioethicists helped to persuade the U.S. Food and Drug Administration (FDA) to essentially ban them.”
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“Had the FDA stayed out of the way, many more families would have had the opportunity to use these and similar assisted reproduction technologies to have healthy children over the past 25 years.”
“The Food and Drug Administration earlier this month fired dozens of staffers responsible for going after retailers who illegally sell tobacco to minors.
Now it’s begging them to come back.
Senior FDA officials asked laid-off employees in recent days to temporarily return after mass cuts decimated the agency’s ability to penalize retailers that sell cigarettes and vapes to minors, four federal health officials familiar with the matter said.”
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“Without aggressive federal oversight, stores would face far less incentive to turn away underage buyers. That could open the door to a reversal in youth tobacco use rates, experts said, undercutting the fight against chronic disease that Kennedy has vowed to make the centerpiece of his agenda. The civil penalties office also served as a key tool in combating growing sales of illicit vapes.
People who smoke cigarettes, use e-cigarettes or other tobacco products primarily begin before they turn 18, research shows, elevating their risk for a range of chronic diseases like lung cancer and heart disease.”
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“It remains unclear why HHS gutted the office focused on civil penalties, which is known within FDA’s tobacco enforcement apparatus as the Division of Business Operations. The Center for Tobacco Products is funded entirely by user fees paid by industry, meaning the terminations won’t create any taxpayer savings. Instead, officials said, it may end up costing money; the fines that the FDA collects from retailers are funneled directly to the federal treasury.
Kennedy, who has singled out smoking as particularly detrimental to Americans’ health, argued in a recent CBS News interview that all the jobs eliminated across HHS were either administrative or deemed redundant.
“In some cases, we cut programs, but we only did that when we consolidated them into another program,” he said. “So the task will continue, their mission will continue. The people are still there for the most part.”
Yet within the FDA, the officials said the cuts effectively collapsed its tobacco enforcement operation.”
“at the Food and Drug Administration, the Trump administration is backpedaling on some of its terminations, reinstating workers in the agency’s medical devices division after realizing they were responsible for approving and monitoring the safety of life-saving equipment like pacemakers and defibrillators.”
“There are many reasons a person could find themselves homeless, but severe mental illness is a major contributor. Last month, Esquire ran a first-person account of Patrick Fealey, an award-winning journalist who found himself unable to hold a job after he was diagnosed with Bipolar I disorder in 1997; after struggling for years, he became homeless in October 2023. While admitting that his particular cocktail of drugs is not ideal and negatively affects other parts of his body, Fealey writes that it also “enables me to function and has kept me alive for twenty-seven years.”
A 2019 meta analysis of 31 studies, encompassing nearly 52,000 homeless people in both developed and developing countries, found that more than 10 percent had schizophrenia or related disorders.
“While ensuring drug safety is essential,” Singer and Bloom write, “the REMS program has unintentionally created barriers that disproportionately affect individuals with severe mental illnesses like schizophrenia, further compounding the significant challenges they already face, including unemployment, substance abuse, heightened suicide risk and homelessness.””
“The concept of nutritional and ingredient labeling is even more complex in the alcohol space since the TTB uses a pre-approval system for alcohol labeling, meaning that alcohol producers have to submit their proposed labels to the agency for approval before the product ever hits the market. No approval, no market access. This is in marked contrast to most food labeling, which the Food and Drug Administration enforces after a product goes to market.”
“while Americans are having more and more difficulty getting access to pain-relieving opioids, the FDA forces them to wait for an alternative to opioids that people in much of the developed world have been using for years.”
“As earlier threatened, the Food and Drug Administration (FDA) has just issued new rules that will significantly slow down the development of new diagnostic tests. Specifically, the agency requires that all laboratory-developed tests (LDTs) be submitted to its regulators before the tests can be offered to patients and physicians. As I explained earlier, LDTs are in vitro diagnostic (IVD) tests for clinical use that are designed, manufactured, and performed by individual laboratories. They can diagnose illnesses and guide treatments by detecting relevant biomarkers in saliva, blood, or tissues; the tests can identify small molecules, proteins, RNA, DNA, cells, and pathogens. For example, some assess the risks of developing Alzheimer’s disease or guide the treatment of breast cancer.”
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” “Laboratory developed testing services are not medical devices and subjecting them to medical device regulation will harm patient access to needed testing and compromise innovations that drive personalized medicine,” said American Clinical Laboratory Association President Susan Van Meter in a statement. “The rule will limit access to scores of critical tests, increase health care costs, and undermine innovation in new diagnostics.””
“Sunscreen is regulated like a drug, which means the product is subject to byzantine FDA regulations that have largely thwarted innovation in the category for the last 20 years.
As the economist Alex Tabarrok has pointed out, European and Asian countries enjoy vastly superior options.
“Suncreens in Europe and Asia are better than in the United States because more ingredients are allowed and these create more effective and more pleasing suncreens,” he writes.
This is no accident, but rather the deliberate result of regulatory policy. The European Union, for instance, has approved 27 different compounds for use in sunscreen, whereas the FDA has only approved 17.
“The number of approved ingredients matters because not all filters can seamlessly be formulated into sunscreens or other suitable products for skin application,” writes the Cato Institute’s Gabriella Beaumont-Smith. “Moreover, some of the ingredients approved in the EU and Japan but not the US are more effective and long‐lasting.”
If the FDA won’t clear more sunscreen ingredients for use in the U.S., the agency should at the very least allow reciprocity: Foreign sunscreens could be made available with warning labels noting that they were approved by European health officials but not by the FDA. Of course, the best option would be for U.S. regulators to simply get out of the way and acknowledge that these products are obviously safe for human use. Indeed, not approving them is the greater danger, since using sunscreen is one of the best ways to prevent skin cancer.”
“For decades, the American College of Obstetrics and Gynecology, the American Academy of Family Physicians, the American Medical Association, and the vast majority of practicing reproductive physicians have called for the Food and Drug Administration (FDA) to make hormonal contraceptives (e.g., birth control pills) available over the counter (OTC) to women of all ages.
When experts in the field who get paid for prescribing hormonal contraceptives nonetheless keep telling patients, “You don’t need to see me for this,” government regulators should take notice. Women can get birth control pills OTC in over 100 countries, formally or informally, around the globe. It’s time for them to be OTC in the “land of the free.””