FDA

COVID-19 has spread across the media much faster than across the world. The uptick is seen in the articles we're bringing forward this week. But rather than concentrate on what to do -- which has already been amply covered -- we're sharing reflections on how we got here. And what we can do differently.
We are holobionts, those who thrive in a saline environment, crafting of at least two species living in close proximity with one another. The other species is our gut microbiome, those microbial communities residing in our bowels and providing us with nutrients and signals. There's no denying their importance. But not as much can be said for probiotics –- the live microorganisms marketed to us with claims to better our health.
We wrote a little over a month ago about the large number of institutions not reporting study results, as required on ClinicalTrials.gov. Now, Stat reports that a federal court has ruled that those reports must be filed, although the timeframe for compliance remains ambiguous.
If you're a government agency like the CDC, the best time to admit to a huge mistake is on Friday afternoon before a three-day weekend. And if you're a government agency like the FDA, there's never a good time to make a boneheaded decision.
The denial of prescription analgesic medication to chronic pain patients has caused unnecessary suffering. But it has also driven up the suicide rate, trapping those who cannot bear to live without the drugs that have kept them functioning for years. ACSH advisor Red Lawhern, Ph.D., discusses the tragedy of intolerable pain.
The rest of the world has not been out snoozing in the sun. But Americans have had access only to older generations of sunscreens that prevent sunburn — but not the deeper damage that can cause skin cancer.
While an investigation is underway into the exact nature of the problem, so far the likeliest explanation is that improper use of vaping devices has led to illness, or the death, of some users. But that sort of nuance isn't governing the thinking of the FDA or CDC officials, both of which are allowing myths and fearmongering to drive their policies and public statements.
What's an "Impossible Burger" you ask? Among other things, it contains soy protein, sunflower oil and a plant-based binder that produces the right mouth/feel properties. But, no sooner than the FDA finally approved this creation for sale, the nutrition police are now saying that it just isn't healthy enough -- and that it may possibly harm us. Give us a break.
The Trump Administration recently issued two executive orders relating to biomedical science. The first involved the regulation of biotechnology products; the second involved transparency in healthcare costs. We believe both are a step in the right direction.
Recently, the FDA met to discuss CBD, the non-psychoactive component of marijuana. It made us realize that we'd never really considered the definition of a drug. Any process involving lawyers hinges on the meaning of words, so what actually does the FDA regulate?
Dr. Henry Miller, a former FDA deputy commissioner, used to be a big fan of the New York Times' coverage of science and medicine. But no longer. He takes issue with an editorial that accuses the agency of reducing its scrutiny of new drugs. Dr. Miller explains why the Times is off-base: the development of precision medicine.
The FDA is supposed to regulate absence claims. But when it comes to GMO absence claims, the FDA has done absolutely nothing. That may be about to change.