Pharmacy Compounding Advisory Committee backs use of compounded glutathione

Photo Cred: Polina Tankilevitch/Pexels

By John McCormack

In a vote that ran counter to expectations, the Pharmacy Compounding Advisory Committee (PCAC) – the group that advises the U.S. Food and Drug Administration (FDA) on drug compounding issues – put its stamp of approval on compounded glutathione. PCAC uncharacteristically rejected the FDA staff’s recommendation to ban the substance for compounding purposes and told the governing body that the substance, which is widely used by integrative practitioners, should be placed on the approved list for compounded prescriptions.

“The committee has a very poor track record of voting against what FDA staff recommends and FDA staff have a very prominent track record of voting against inclusion of most of the nominated substances that have come before,” said Laura Farr, executive director of the American Association of Naturopathic Physicians (AANP). “We’ve been tracking this now since about 2017 and the committee has rejected about 98 percent of what’s been nominated.”

As such, while unexpected, the vote was a welcome change of course for integrative healthcare providers who prescribe – and patients who use – compounded medications.

“The vote thankfully ensures that patients won’t have any disruption in the care that has been personalized specifically for them by their provider and pharmacist,” Farr said. “Although there will be another step in the process – when the FDA finishes reviewing all ingredients, they will put together a final rule which will also be open to public comment and a vote. So, we will need to continue defending glutathione’s use.” 

Providing this defense is nothing new for integrative care practitioners and groups. The AANP and others have been rallying against the FDA’s proclivity to issue rules designed to restrict patient and provider access to compounded treatments for quite some time.

According to the AANP’s website, for the past several years, the FDA’s default position has been “that if there is an FDA-approved pharmaceutical drug for a specific condition, then a compounded substance is unnecessary — despite the needs of thousands of patients who may not be able to use the FDA pharmaceutical safely.”

Traditionally, pleas from supporters of compounded substances have fallen on deaf ears at the FDA, according to Farr. The problem could be tied to the fact that the integrative care model is decidedly different than conventional medicine.

“The FDA is approaching this [with] a very narrow lens and it is philosophically different than how most integrative medicine practitioners practice,” Farr said.

Prior to the June 8 meeting, it looked as if FDA staff would prompt the committee to focus on about 20 specific uses for glutathione including skin lightening, asthma, chronic lung disease, oxidative stress, and others, according to a PCAC meeting announcement. Fears that the PCAC would accept the FDA staff recommendation against glutathione being placed on the 503A Bulks List, which includes bulk drug substances that can be used in compounding, weighed heavily on the integrative care community, as it looked as if the committee would merely zero in on these uses, according to an article in Integrative Practitioner.

“As we all know in integrative medicine, there isn’t always necessarily a huge body of research on a specific ingredient for a specific disease,” Farr said.

The problem in the past has been that the FDA ignores input based on clinical experience, according to Farr. “They’re only looking at if there is a double-blind placebo control study on these specific [diseases] and they’re discounting any kind of functional use and any kind of clinical experience. Even if it’s dozens and dozens of years of clinical experience, it’s just dismissed,” she said.

Change of heart

Integrative healthcare groups and individuals, however, convinced the PCAC members to buy into their reasoning when it comes to the use of compounded glutathione.

Paul Anderson, NMD, a Seattle-based physician, is representative of the many voices that attested to the clinical value and safety of glutathione in the PCAC review.

“For over 20 years, in my own personal practice experience, I’ve used the pharmaceutical compounded version of glutathione in a number of avenues,” Anderson said. “I have a very extensive background prescribing it.”

Anderson pointed out that he routinely prescribes glutathione for respiratory illness, surgery and chemotherapy recovery, and neurological and cardiac inflammatory conditions.

“It’s quite versatile because it’s already in the human body and it holds a key place in our antioxidant defenses,” he noted.

In addition, compounded medications are especially important for patients who suffer from diseases that are not addressed by FDA-approved drugs. For example, according to the Myalgic Encephalomyelitis Action Network, the FDA has failed to introduce drugs that help with chronic fatigue syndrome or myalgic encephalomyelitis. Glutathione, however, focuses on restoring a process in the body that is blocked in people who might be deficient in glutathione.

FDA staff also brought up safety concerns in its recommendations to the PCAC. However, Farr pointed out that these concerns were tied to very specific uses such as skin whitening, “which is not really how the majority of U.S.-based integrative medicine practitioners are using glutathione,” she said. In addition, FDA staff pointed to safety concerns associated with “using doses of compounded glutathione, which are way higher than what many integrative medicine practitioners are using glutathione for in functional medicine,” Farr said.

Anderson agreed and added that FDA staff often cast safety issues in an unfair light.

“There are, in my estimation, scientific issues with the type of data the FDA chooses [to review] … when it comes to safety. Just in regard to respiratory [conditions], there are FDA drugs that have probably 1,000 times the number of adverse events as glutathione, maybe 10,000 times and they’re FDA approved drugs. And they’re allowed to be used every day. So, the fact that they would exclude glutathione for a very small number of adverse events is scientifically disingenuous,” he said.

Worth the bother

The fact that the PCAC didn’t accept the FDA staff’s recommendations without pause during the June 8 meeting, however, could in part be attributed to the efforts of the AANP and other groups and individuals who presented evidence in support of compounded glutathione.

The AANP formed a strong working coalition, which included the Alliance for Natural Health, Alliance for Pharmacy Compounding, American Academy of Environmental Medicine, American College for Advancement in Medicine, and the International College of Integrative Medicine, to submit relevant research and testimonies on the importance of glutathione in the naturopathic medical community. In addition, committee members were sent all public comments made to the docket ahead of the meeting – and this apparently had the desired effect.

According to Farr, this input could have prompted committee members to become concerned about the patients who would lose access to treatment if compounded glutathione was banned. In fact, one member of the PCAC committee, according to a statement from AANP, explained their “yes” vote by noting that they “found the [FDA’s] review of the efficacy [of compounded glutathione] superficial and narrow, and … 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.”

Many other committee members agreed.

“The advocacy of the AANP and our coalition partners puts a real human face on the issue, which makes an otherwise mechanical process more human,” Farr concluded. “All the statements submitted from providers and patients about the safe and essential use of compounded glutathione really helped committee members realize that the ‘evidence’ presented to them by FDA staff against glutathione was superficial, narrow, and completely dismissive of clinical experience.”