The weight loss industry has been transforming faster than anyone can keep up with in the last 24 months. Federal and state changes are constantly evolving. A big shift happened recently when all Tirzepatide medications and all but one semaglutide medication were shown as being “Available” on the U.S. Food and Drug Administration’s (“FDA”) Drug Shortage List.
So what does the switch to “Available” mean for the weight loss practitioners? Well, not much, actually.
FDA Classification
The FDA’s Drug Shortages Database lists product information as it is given to FDA by the manufacturers. Although all dosages of a drug may currently be listed as “Available,” the criteria for moving a drug off the Drug Shortages list is determined by the FDA. FDA will move a drug in shortage from Current Shortage status to a Resolved status (and therefore off this list and onto a new list) when supply meets total national historical demand.
Per Amanda M. Hils, the Press Officer for the FDA, even after a manufacturer indicates their drug is “Available,” the FDA “continues to actively monitor drug availability and work with the company to confirm the supply is stable and help ensure patient access to safe, effective drugs. The FDA is currently working to determine if the available supply of Tirzepatide would meet our definition of a Resolved Shortage.” Ms. Hils further opined that the FDA would continue to evaluate “the entire market, assessing whether all backorders have been filled and supply is meeting or exceeding demand. In making this evaluation, FDA may consider, among other factors, affected market share, ability of alternate manufacturers to cover the demand, and confirmed market stabilization.” Only if this assessment determines enough sufficient supply factors are met would the FDA consider the weight loss drugs shortage to be resolved and communicate that resolution. As implied by Ms. Hils’ response, even the FDA is uncertain as to whether the current supply level from the brand-name manufacturers is sufficient to meet current demand.
The bottom line is, when a drug listed in the FDA’s Drug Shortages Database is not designated as resolved and subsequently removed from the database, it is still considered to be in shortage, regardless of an “Available” designation. In such case, the exemption allowing compounding pharmacies to compound/manufacture these medications is still in effect.
What’s Next
However, the unknown is for how long the FDA will monitor the market and when the shortage status will be resolved. Once the shortage ends this will have several effects on current and future weight loss practices so they should begin now preparing for the potential change.
Marketing
Once removed from the shortage list, there no longer being an FDA approved way to compound copies of these medications and compounded versions can no longer be marketed. Your advertising and marketing will need to be updated to remove references to offering “compounded Tirzepatide,” “compounded semaglutide.” Advertising and marketing uses of the terms themselves should only be used if your practice begins using the name brand drug. When offering the name-brand products you can advertise as allowed by Eli Lilly’s and Novo’s marketing policies. Marketing and advertisements that do not discuss specific drugs, such as generically advertising “medical assisted weight loss”, would be compliant provided that meet your state’s advertising rules.
Patient Consents
Additionally, once removed from the shortage list, your patient informed consents, policies, and procedures that discuss the use of compounded versions of these medications must be updated. However, the discussion of off-label use of these medications will still be required when applicable.
Patient Care
When the compound versions can no longer be produced, there will be a change or disruption in how you obtain your supply of the medication. There may be a period where the compound versions are still available from pharmacies but once those stocks are exhausted, only the name brand drugs will be available from pharmacies and suppliers. Existing supplies of legally obtained compounded versions can still be used. If consistent with your state’s standard of care you can continue to treat patients with the compound versions. However, you should begin developing a solution to obtain the name brand versions as soon as possible.
You will also need to develop a plan to transition from the compounded drug versions to the name brand versions. Although the source for this type of medication is changing, your professional duty in treating you patient remains the same. You will need to inform and work with your patients to develop a plan to address these change in medication supply to maintain the continuity of treatment. This will vary by individual circumstances but may involve assisting with finding new pharmacies, adjusting treatment to other methods or medication, transferring treatment to different providers, or guidance on discontinuing treatment.
One important aspect will be the change in cost. You will need to develop a plan and communication to your patients educating them on what these changes mean and how they will be affected.
Current Supplies
For practices which have outstanding orders for the compounded medication, the FDA notes that when a drug comes off the shortage list, the FDA will not take any action if the distribution of the compounded drug occurs within 60 days of the shortage being resolved. As such, practices may continue to use their remaining product but only for a short duration.
Navigate Compliance with ByrdAdatto
At ByrdAdatto we are working hard to ensure our clients are up to date with the latest regulation and rule changes to maintain compliance. If you have any questions about this alert, please contact ByrdAdatto.
