The US Food and Drug Administration (FDA) will restrict the creation of copycat weight-loss drugs due to supply shortages. A federal judge declined an injunction that would have allowed compounding pharmacies to continue making more affordable versions.
When demand for popular weight-loss drugs was high, the FDA allowed compounding pharmacies to create copycat drugs. However, when drug companies said they could meet demand, those pharmacies were no longer able to sell the copies. Dr. Tara Narula explained this process in a Good Morning America segment.
In 2022, patients turned to compound versions of weight-loss drugs due to supply shortages. Around 200,000 prescriptions for copycat Novo Nordisk’s Wegovy alone were filled each month. However, since then, the original drug companies have removed their products from the FDA’s shortage list and are now meeting demand.
The FDA has declared that selling copycat versions “with rare exceptions” is now illegal. The decision was welcomed by Novo Nordisk’s president, Dave Moore, who stated that patients should not compromise their health due to misinformation and illegitimate knockoff drugs.
The impact on patients will be significant, as they pay a fraction of the price for real weight-loss drugs, which average around $1,000 per month. Telehealth companies may also be affected by this change.
A petition has been started by the GLP-1 Collective to allow compounding pharmacies to continue making the drugs and advocate for generic versions, insurance coverage, and competitive pricing. The petition has garnered over 24,700 signatures so far.
Source: https://www.fastcompany.com/91296440/compounded-wegovy-and-zepbound-may-disappear-under-new-fda-rules