On June 8, 2022, the Pharmacy Compounding Advisory Committee (PCAC) – the committee that advises FDA on matters related to drug compounding – voted yes to allow for compounded glutathione to be included on an approved list for compounded prescriptions. In a surprising vote, the PCAC went against FDA’s recommendations to ban the substance for compounding purposes.
History shows that typically the PCAC follows FDA recommendations. In this case, the advisory committee did not agree with FDA’s recommendations to ban the ingredient from use for compounding. According to a news account about the meeting from the American Association of Naturopathic Physicians (AANP), ‘”One member of the PCAC committee went on to explain their “yes” vote, noting that they “found the [FDA’s] review of the efficacy [of compounded glutathione] superficial and narrow, and I found their conclusion’s [on the research available] dismissive of the positive data because the outcome wasn’t something they [FDA] were interested in looking at.”‘
Given that the PCAC usually supports the FDA recommendations, the AANP and all the stakeholders who sent in comments were more than pleased with the outcome. The AANP worked diligently to form a strong working coalition to submit relevant research and testimonies on the importance of glutathione in the naturopathic medical community. “This is a major victory for patients and providers in a process that has been stacked against natural ingredients,!” AANP wrote in a response statement following the vote. “The statements and comments from providers and patients highlighted to the committee the long, safe, and essential use of glutathione and caused several PCAC members to question the exclusively negative data brought forward by FDA staff.”
“The Institute for Natural Medicine is proud of AANP’s work to educate decision makers about the importance of compounded ingredients like glutathione,” said Michelle Simon, PhD, ND, president and CEO of INM. “The work that AANP is doing is so important to patient health. While compounded glutathione has always been an important ingredient for naturopathic doctors to prescribe, it is even more important now. Recent research shows that a majority of people who have had COVID-19, likely have a glutathione deficiency (more on that here).”
Glutathione is only one of 300 ingredients that FDA has threatened to make illegal for compounding. Compounding medications are a vital to naturopathic doctors because naturopathic medicine is based on a personalized approach. They prescribe customized medications to meet the specific needs of each patient. For instance, some patients have allergies to common fillers, they may need a customized dosage or delivery system, or they simply may not be able to swallow a pill. Each of these issues present complications for the patient and interfere with compliance. Compounded medications provide a customized solution in a medical world that is all too often a mass-produced one-size-fits-all pharmaceutical medications.
To learn more about the work that AANP does to convince the FDA and voting advisory committees, like the PCAC, that limiting access to compounded substances would be harmful to patient health, please follow this link. The Institute for Natural Medicine is proud of the work that AANP does educate physicians, the public, congressional offices, and FDA on the safety and efficacy of compounded medications and why they are important to health.
This article is provided by the Institute for Natural Medicine, a non-profit 501(c)(3) organization, partnered with the American Association of Naturopathic Physicians. INM’s mission is to transform healthcare in America by increasing both public awareness of naturopathic medicine and access to naturopathic doctors for patients. INM believes that naturopathic medicine, with its unique principles and practices, has the potential to reverse the tide of chronic illness that overwhelms existing health care systems and to empower people to achieve and maintain their optimal lifelong health. INM strives to achieve this mission through the following initiatives:
- Education – Reveal the unique benefits and outcomes of naturopathic medicine
- Access – Connect patients to licensed naturopathic doctors
- Research – Expand quality research of this complex and comprehensive system of medicine
This article is by Kimberly Lord Stewart, content and marketing director for the Institute for Natural Medicine. Stewart is an award-winning editor, food and health journalist and best-selling author of Eating Between the Lines, the supermarket shopper’s guide to the truth behind food labels (St. Martin’s Press).