FDA plans to ease up on approvals for some drugs
U.S. regulators proposed new guidelines Tuesday to make it easier for some common medicines to be sold without a prescription – and more convenient for consumers to get them.
The Food and Drug Administration is evaluating ways to make sure patients don’t take an inappropriate over-the-counter drug, Commissioner Scott Gottlieb said in a statement. That could include adding information to the packaging label and offering online questionnaires to help people decide if a drug is right for them.
Drugmakers would have to do studies showing those strategies allow consumers to safely pick a drug and use it without medical supervision.
The agency will take comments from drugmakers, medical groups and the public before issuing final rules, a process that usually takes many months.
Many widely used nonprescription drugs originally were available only by prescription, requiring a doctor visit and sometimes coverage approval from insurers.
Examples include many pain relievers, allergy treatment Claritin, heartburn remedy Prilosec, Imodium for diarrhea and Monistat for yeast infections.