An Affront to Health Freedom: The FDA Recategorizes 17 Therapeutic Peptides

Since the development of insulin in 1921, scientists, healthcare professionals, and individuals seeking medical solutions have identified peptides as potentially beneficial in addressing a broad range of conditions. These benefits include peptides for weight loss, anti-aging, managing chronic illnesses like Irritable Bowel Syndrome, and even combating cancer.

But, last September, the FDA released new guidance that shocked the world of peptide medicine: 17 oft-used therapeutic peptides, including BPC-157, epitalon, and thymosin alpha-1 (Ta1) were added to the Category 2 Bulk Drug Substance list, barring compounding pharmacies from creating and distributing a long list of peptide-based therapies and preventing patients from accessing much-needed medicine.

Then, as the peptide industry, providers, and patients who rely on these innovative therapies, reeled from the recategorization, the FDA approved a peptide-based drug for weight loss made by Eli Lily, a major pharmaceutical company. Likewise, Big Pharma drugs, which are FDA- approved and use these recategorized peptides as their dominant ingredient, have not encountered regulatory consequences following this new guidance.

As the result of the FDA’s decision-making, which seems to show a bias toward Big Pharma, potentially life-altering therapies are now inaccessible to patients and providers, providers are handcuffed from offering appropriate care. All of this violates a patient’s health freedom, or right to choose a preferred form of medical care without interference.

What Recategorization Means

The FDA consistently assesses substances proposed for incorporation into the Bulk Drugs List, an inventory of FDA-approved substances permissible for compounding into medicine. As Category 2 substances, these 17 peptides are now inaccessible to patients and providers, despite the promise they’ve shown in addressing certain conditions.

Studies suggest the now-banned peptides GHK-Copper may have potent anti-aging affects, AOD-9604 may assist in weight loss, and BPC-157 may address central nervous disorders, gastric ulcers, and Irritable Bowel Syndrome. Likewise, Thymosin alpha-1, or Ta1, a peptide that naturally occurs in the human thymus gland, is also off-limits now. In 30 countries outside of the U.S.A., this drug has been approved for the treatment of hepatitis B, hepatitis C, and the management of cancer-related symptoms.

The FDA justifies their recategorization by asserting that these peptides fall under “bulk drug substances that pose notable safety concerns.” These concerns, they say, arise from insufficient safety data, the existence of impurities, and the potential for adverse immune responses affecting drug safety and efficacy, known as immunogenicity.

That said, a lack of data doesn’t necessarily suggest a lack of safety, much of the data that does exist suggests these peptides are well-tolerated, and likewise, when sourced from accredited, reputable compounding pharmacies with good manufacturing processes, the risk of a patient obtaining impure or unsafe peptides is drastically reduced.

“It is hard to see the harm in letting a terminally ill patient get access to an experimental drug under the rubric that the FDA is protecting us from exposure to drugs not proven safe and effective,” said one article about access to experimental drugs, published in the monthly journal, U.S. Pharmacist. “If the patient wants to take the chance, is able to pay for the drug and is willing to waive liability, shouldn’t he or she be allowed access anyway?”

Instead of considering these arguments, the FDA has simply banned these peptides, blocking providers from a broader range of care options and patients from their right to access the care that suits them best.

Big Pharma Cash Grab

The FDA’s new guidance around peptides suggests that they are more interested in the money made to be made from this burgeoning industry, than in investing in widespread peptide research and accessibility for the sake of people’s wellness.

After all, the FDA is largely funded by the pharmaceutical companies it regulates, and by barring compounding pharmacies and small clinics from participating in the market, the FDA allows Big Pharma to profit exclusively from the peptide therapeutics industry. This industry was worth $42.70 Billion in 2022 and is projected to grow by 6% CAGR by 2032.

In fact, the FDA has a long track record in going after alternative medicines and independent clinics and pharmacies that allow patients and providers to circumvent costly Big Pharma drugs. According to another article in U.S. Pharmacist from 2011, the FDA has made “several lengthy…attempts to restrict compounding pharmacies” to “expand its power by regulating a multitude of issues affecting pharmacy practice and the rights granted to states by the U.S. Constitution.”

Likewise, according to Science, Big Pharma has been providing hundreds of thousands of dollars in kickbacks to FDA advisers as an incentive to approve their drugs.

According to the Biotech Industry Newsletter Profits & Pioneers, the public’s caught wind of such unethical behaviors and grown “increasingly skeptical of the Administration as the complexity of the political relationships between other government agencies and the private sector grows.

When it comes to this decision about peptides, that skepticism is again, well-founded. While compounding pharmacies are being barred from creating potentially life-saving drugs and providing them at affordable prices, drugs like Thymalfasin, a Big Pharma peptide drug that was FDA-approved in 2006 and is made from the recently-recategorized synthetic peptide thymosin alpha 1, remains on the market without issue.

What Can Be Done

While the FDA hasn’t instigated a permanent ban of these peptides, this interim decision does not bode well for their continued availability.

That said, there are actions the public can take to safeguard their access to peptides. For one, you can donate to the Peptide Legal Fund, which supports research, legal resources, and advocacy efforts aimed at urging the FDA to reevaluate the classification of these Category 2 peptides.

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