As the United States prepares to widen public access to the drugs, Australia continues to take a cautious approach.
The Medical Board of Australia says it is working on new guidance for prescribing off-label, unapproved, and compounded medicines in the wake of the peptide boom, even as other countries move to loosen restrictions.
According to the board’s newsletter, AHPRA and the Therapeutic Goods Administration are working in concert to “keep patients safe and practitioners on track” amid “a massive uptick in unapproved peptide use”.
“If you’re prescribing peptides or active in the wellness sector, look out for new guidance coming soon that sets out your professional responsibilities when prescribing in new pharmaceutical frontiers,” the newsletter read.
“We’re concerned that high consumer demand for peptides is leading some practitioners to side-step their professional responsibilities.
“By putting profits ahead of patients, these practitioners are putting public safety at risk and could face regulatory action.”
The guidance will specifically cover professional responsibilities when prescribing off-label, unapproved or compounded therapeutic goods and will aim to “bring clear focus, not new rules”.
“The new guidance will remind you about your responsibility to assess patient and medicine suitability, gain informed consent and document the consultation,” the medical board said.
The term “peptides” encompasses a wide range of medicines, including TGA-approved GLP-1 receptor agonists like semaglutide.
The unapproved peptides that the medical board is referring to are synthetic injectable drugs marketed as performance enhancement or anti-ageing supplements. Some are sold online with the caveat that they are for “research use only”.
The unapproved nature of these drugs means they have not been assessed by the TGA for safety, quality or efficacy.
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Over recent months, the TGA has put out progressively forceful releases warning the public about these drugs.
Earlier this month, it announced that it would be stepping up compliance action against businesses and individuals advertising, importing, manufacturing, supplying or exporting unapproved peptide products.
The United States, meanwhile, appears to be heading in a different direction.
Last week, an advisory panel to the Food and Drug Administration recommended that compounding pharmacies be allowed to manufacture various peptide drugs.
The panel in question, the Pharmacy Compounding Advisory Committee, is made up of FDA-selected experts and members put forward by the federal government’s health department.
According to reporting in US publication STAT, several of the government-appointed members who voted in favour of the change either worked at clinics that prescribed peptides or had other industry ties.
Nearly all FDA-affiliated scientists on the advisory group opposed the change.
If the decision is upheld, compounding pharmacies – which were previously banned from manufacturing around 19 peptides due to safety concerns – will be able to manufacture six of the drugs.
This decision does not mean the drugs are approved. It simply means that they will be legal to make and sell.
The Australian Financial Review reported that the market for the drugs could grow into a “multibillion-dollar opportunity for pharmacies, telehealth providers and drugmakers”.
It also noted that telehealth company Hims, which is in the process of acquiring Australian telehealth startup Eucalyptus, acquired a peptide-manufacturing company last year.
As reported in the AFR, Hims’ chief medical officer said the company was “excited” about peptides but would await guidance from the FDA.
The FDA is not legally obligated to follow the recommendations of its advisory committees. It will issue a final decision on the matter in coming weeks.
The Medical Republic contacted Eucalyptus for this story, but it declined to comment on record.
TMR also contacted the TGA for comment but did not receive a response before deadline.
