Here are five things to know.
1. Under current law, homeopathic drug products must pass the same regulatory scrutiny as other drug products. However, a regulatory policy established 1988 has allowed homeopathic therapies to reach the market without FDA approval.
2. Under the newly proposed regulations, the FDA would be able to increase its regulatory authority over high-risk homeopathic products. Such products include those administered via injection, those intended for vulnerable populations like infants or the elderly, and those marketed for the treatment of serious illnesses like cancer.
3. Homeopathy is rooted in 18th century thought, which suggests substances that cause disease can also cure symptoms when administered in small doses. Modern medicine has debunked the core tenets of homeopathy, according to a report from The Washington Post.
4. The move from the FDA comes more than a year after homeopathic teething tablets containing belladonna were linked to 400 adverse events and 10 child deaths.
“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer,” said Scott Gottlieb, MD, commissioner of the FDA. “In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse — that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients. … We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.”
5. The FDA will be accepting public comments on the draft proposal for 90 days.
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