US proposes restricting weight-loss drug copies

The US Food and Drug Administration (FDA) has proposed new restrictions that would limit the ability of outsourcing facilities to produce compounded versions of popular weight-loss and diabetes medications.In a statement on Thursday, April 30, the agency said it plans to exclude certain active ingredients used in these drugs from the bulk substances list available for compounding, a move that would tighten regulatory controls.When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need, FDA Commissioner Marty Makary said.This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.The FDA said it found no clinical justification for compounding key ingredients such as semaglutide, used in Novo Nordisks Ozempic and Wegovy, as well as tirzepatide, found in Eli Lillys Zepbound and Mounjaro. The proposal also covers liraglutide.Compounding differs from the production of generic drugs. While generics are FDA-approved and must meet strict standards, compounded drugs are created using approved ingredients but are not themselves verified by the agency.The practice had been temporarily tolerated in the case of weight-loss drugs due to high demand and supply shortages. However, concerns have grown over safety risks, including potential issues with dosage accuracy, product quality and regulatory oversight.If the proposal is finalised, compounding of these medications would only be permitted during periods of confirmed shortages. The FDA has opened the proposal for public comment, with submissions accepted until June 29. The announcement boosted pharmaceutical stocks, with Novo Nordisk rising more than six percent and Eli Lilly climbing over eight percent in early trading.The post US proposes restricting weight-loss drug copies appeared first on Linda Ikeji Blog.