October 16, 2024
Strive Pharmacy Discontinues Peptides: What You Need to Know
At WellCentric Health, we want to inform our patients that Strive Pharmacy will no longer provide peptides for our prescribing purposes. This change reflects a broader trend among compounding pharmacies in response to new FDA regulations introduced by the Biologics Price Competition and Innovation Act (BPCIA). These regulations classify many peptides as biologics, requiring pharmacies to obtain costly biologics licenses for production. Unfortunately, most compounding pharmacies, including Strive, lack the resources to meet these new requirements, effectively ending their ability to offer peptide-based therapies.
Why Has This Happened?
The FDA has cited safety concerns, such as a lack of extensive human trials, potential immune reactions, and contamination risks in compounding processes, as reasons for tightening peptide regulations. However, many healthcare professionals and patients are skeptical, noting that peptides have been used safely and effectively for years. The shift has led some to question whether these regulations are primarily about safety or if they are influenced by large pharmaceutical companies aiming to eliminate competition from smaller compounding pharmacies.
The Impact of Classifying Peptides as Biologics
The BPCIA restricts compounding pharmacies from making peptides by classifying many of them as biologics, which are advanced medications made from living cells or organisms (see the biologics definition below). Since most compounding pharmacies lack the resources to secure a biologics license, this classification effectively prevents them from offering peptide-based therapies. Many believe this regulation benefits Big Pharma by limiting competition, as larger companies are better positioned to meet the expensive licensing requirements.
While the FDA claims these measures are necessary to ensure safety, critics argue that they undermine access to affordable, personalized treatments that compounding pharmacies offer.
What Are Biologics?
Biologics are advanced medicines made from living cells or organisms, often used to treat conditions like autoimmune diseases and cancers (think of the medications you frequently see advertised on TV). They differ from traditional drugs, which are typically made from chemical compounds. Examples of biologics include well-known medications like Humira, Dupixent, or Enbrel.
How This Affects You
While this issue may not directly affect you today, it could in the future as health needs change or new medical concerns arise. Peptide therapies have provided significant benefits for many patients, and restricting access to these treatments could limit your options down the road. At WellCentric Health, we believe that patients and physicians should have the freedom to choose safe, personalized treatments, including compounded medications.
Take Action to Protect Access to Compounded Medicines
If you share our concern about these restrictive regulations, there are several ways you can advocate for change:
- Advocate for Policy Reform – Reach out to your local and federal representatives to express your concerns about the FDA’s peptide regulations and push for legislation that supports more flexible compounding practices.
- Join Advocacy Groups – Support or join groups like the Alliance for Natural Health USA and the International Peptide Society, which are actively working to challenge these regulations.
- Raise Public Awareness – Share information on social media, blogs, or community forums about how these regulations are affecting patients and healthcare providers. Public awareness can create pressure for regulatory change.
- Provide Public Comments – When the FDA opens public comment periods, take the opportunity to submit your feedback and suggest alternative solutions that ensure both safety and accessibility.
- Support Independent Research – Help fund or participate in studies that demonstrate the safety and effectiveness of compounded peptides, providing essential data to challenge current regulatory assumptions.
The new regulations on peptides have sparked concern, but with collective effort, we can help advocate for greater access to personalized, compounded medicines. Together, we can work to ensure that patient care remains flexible and accessible.