The FDA has made a public stance not taken since the early days of stem cell treatments, directly targeting the non-FDA approved GLP-1 drug market. This focus on enforcement targets compound pharmacies and clinics (brick and mortar as well as telehealth) that provide these types of drugs to patients.
What does this mean? The days of compounded GLP-1 drugs (aka weight loss drugs) are numbered. The products will begin to disappear from the market in such great volume and access to specialized, individualized GLP-1 drugs will be limited. Most telling from the FDA statement is the naming of arguably the largest telehealth, direct to consumer provider (HIMS&HERS), meaning that the FDA is focused just as much on clinics as pharmacies.
This will take time to gather up all “violators” but make no mistake, the FDA and the name-brand manufacturers will be scouring the internet to identify what they deem to be bad actors.
For patients, this means diminished access to their current drugs, increased prices for name brands, and less variety. It could also create a significant short term access issue which leads to a break in protocol.
Clinics and pharmacies should do the following:
- Seek legal counsel to see how this new position will impact their operations;
- Create a protocol to address the changes in patient care;
- Review all vendor contracts that carry long term commitments and financial obligations;
- Review and modify marketing materials
For more information, contact attorney Chase Howard at Older Lundy Koch & Martino
See FDA announcement here: https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
