The Food and Drug Administration has done an about-face
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The U.S. Food and Drug Administration (FDA) is rethinking its decision to remove popular weight-loss and diabetes drugs from the national shortage list. This change means that compounding pharmacies can keep making cheaper versions of these drugs for a while longer.
A group representing these pharmacies sued the FDA because, on October 2, the agency said there was no longer a shortage of the drugs called tirzepatide, which are sold as Mounjaro for diabetes and Zepbound for weight loss.
These drugs have been very popular and effective, along with Ozempic and Wegoby, and were on the shortage list since December 2022.
Because there has been more demand than supply, pharmacies were legally allowed to make copies of these drugs. Normally, they can only do this if the drugs are on the shortage list. But after the FDA's announcement, these pharmacies were told they couldn't make more of these drugs and had 60 days to finish existing orders.
What changed? The FDA said it decided to end the shortage because the drug maker, Eli Lilly, promised that it could produce enough of the drugs to meet the demand across the country. However, the FDA warned that there might still be some local supply problems.
In their lawsuit, the pharmacies argued that the shortage is still a problem and that the FDA just trusted Eli Lilly, which they believe wants to control the market.
FDA asks to suspend the lawsuit
The FDA has moved to diffuse the situation by asking the court to put the lawsuit on hold pending a review. At the same time, the agency said it would not take enforcement action against compounding pharmacies that continued to turn out copies of the drugs while the review is taking place.
Eli Lilly is not very happy with the FDAs decision. Its position is that there is currently enough Mounjaro and Zepbound available to meet demand.
Patients, however, may be happy since the drugs produced by the compounding pharmacies cost less than the real thing.
Photo Credit: Consumer Affairs News Department Images
Posted: 2024-10-17 00:06:41
