F.D.A.’s Approval of a Drug for Autism Upends Review Process

The FDA has approved the use of an old drug, Valproic acid, as a treatment for certain individuals with autism. This decision has caused disruption in the review process, as some consumers have started purchasing over-the-counter supplements containing similar ingredients. The approval of Valproic acid as an autism treatment represents a departure from the typical FDA review process, which typically involves extensive clinical trials and data analysis. In this case, the FDA has expanded the use of an existing drug, citing its potential benefits for a specific subset of the autism population. The decision has led to a surge in demand for over-the-counter supplements with similar compositions, as some consumers seek alternative and potentially less expensive options. This has raised concerns about the safety and efficacy of these unregulated products, as they may not undergo the same rigorous testing and quality controls as prescription drugs. The FDA's approval of Valproic acid for autism treatment highlights the ongoing debate around the balance between innovation, patient access, and regulatory oversight in the pharmaceutical industry.