The FDA is looking to make major changes to its non-prescription drug review system—a system which is more than 40 years old. The system currently in place functions as a way for the government to approve over-the-counter drugs. The new changes that are being proposed are likely to make it easier for the agency to quickly adapt their practices and new drugs to rapid changes in the scientific community. The FDA had previously conducted an examination of their drug review system and determined that there were “significant challenges” related to their current regulations and approval process. When the FDA created the current system, the agency believed that the drug approval process would be “generally about the safety and effectiveness evaluations for the various active ingredients, would be fairly straightforward, and would not necessarily need continuous reexamination over time.”
The FDA now is interested in hearing ideas for changing their process, stating that they are open to “ideas for its replacement with an entirely new regulatory or statutory framework.” The FDA is moving relatively quickly on the ideas for changes, with a public hearing scheduled in late March. The agency posted a document in the Federal Register detailing their concerns with the current system and their hopes for a regulatory change. The FDA hopes that the new regulatory changes will make it easier to monitor and research over-the-counter drugs once they hit the market. Currently, it is difficult to post new warnings or make labeling changes to drugs that are already being consumed by the public.