Tag: Food and Drug Administration
Continued Battle over Homeopathy
The battle to rid modern scientific societies from the blatant and harmful pseudoscience of homeopathy continues. This past year has been overall a good one – in the US both the FDA and FTC decided to review their regulation of homeopathy. They have gathered their testimony and are now apparently reviewing everything. Their decisions on this topic are eagerly anticipated and could...
Worshiping at the altar of the Cult of the Brave Maverick Doctor
One of my favorite television shows right now is The Knick, as I described before in a post about medical history. To give you an idea of how much I’m into The Knick, I’ll tell you that I signed up for Cinemax for three months just for that one show. (After its second season finale airs next Friday, I’ll drop Cinemax until...
US Department of Justice Goes After Supplements
It is shaping up to be a good year for those of us advocating more effective regulation of supplements and unproven therapies in the US. The Food and Drug Administration (FDA) is reviewing its regulation of homeopathy, and recently also announced it is taking public comment on its regulation of the term “natural.” The Federal Trade Commission (FTC) is also reviewing the...
The Amarin case: off-label promotion and a double standard for prescription drugs vs. dietary supplements
A recent court decision enjoined the FDA from threatening prosecution against a drug manufacturer for off-label promotion of a prescription drug. Based on this and an earlier decision by an appellate court, it appears that the FDA can no longer prosecute a pharmaceutical manufacturer for a truthful and non-misleading off-label promotion to health care professionals, at least within the jurisdiction of the...
“Female Viagra?” Misleading Headlines and Regulatory Dilemmas
The FDA recently approved flibanserin (brand name Addyi) for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. The story of flibanserin illustrates several of the issues we have confronted on this blog: It was hyped in the media. Misleading headlines called it the female Viagra. It was initially rejected by the FDA and was approved only after extensive lobbying...
The Federal Trade Commission takes on homeopathy—maybe
Well, I’m back. OK, returning from London isn’t nearly as epic as Sam Gamgee’s final words in The Lord of the Rings returning to his wife and daughter after having accompanied Frodo, Gandalf, Bilbo, and key elves of Middle-Earth to the Grey Havens, there to say goodbye to them as they boarded a ship to the undying lands. I just love the...
Battle of the feds: FTC tells FDA to do its job regulating homeopathy
Last month, the Society for Science-Based Medicine submitted a comment to the Food and Drug Administration (FDA) in response to its request for public comments on the agency’s current regulation (actually, lack of regulation) of homeopathic drugs. As the SFSBM pointed out, the FDA has, without legal authority, exempted homeopathic drugs from the safety and efficacy requirements applicable to other drugs under...
The 21st Century Cures Act: The (Somewhat) Good, The (Mostly) Bad, and The (Very) Ugly
The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients...
Society for Science-Based Medicine: Comment to FDA on homeopathic drug regulation
The Society for Science-Based Medicine has commented on the FDA's reconsideration of how to regulate homeopathic products.
GcMAF and the life and death of an autism quack
[Editor’s note: This is an extra bonus post that has appeared elsewhere. This week’s post will appear in several hours.] A mysterious apparent suicide and conspiracy theories Three weeks ago, those of us who combat the antivaccine movement noted the then-very recent death of an autism quack and antivaccinationist (but I repeat myself) who’s been big in the “autism biomed” movement for...