The Food & Drug Administration (FDA) proposed draft guidelines on Tuesday designed to make more common medications available to consumers without a doctor’s prescription. Officials said the move could make drug purchases more convenient and less costly without compromising safety standards.
Although nonprescription drugs are generally less expensive, many aren't covered by health insurance.
“While the FDA doesn’t have a direct role in the cost of medicines, we’re very mindful of the time and financial cost to patients and the health care system to fill a prescription medicine, particularly one taken repeatedly for chronic conditions,” FDA Commissioner Scott Gottlieb, M.D., said in a statement.
While proposing the draft guidelines, the agency is evaluating ways to help consumers make informed decisions when buying over-the-counter medication. These include providing more information on packaging labels and advising consumers through mobile medical apps and online questionnaires.
Some drugs that once required a prescription have already been made available at lower cost over the counter, including many pain relievers, some allergy treatments, and remedies for heartburn and diarrhea.
Some drugs must require a prescription to ensure that patients consult a doctor and get appropriate testing, Gottlieb said. “But other, select types of drugs are appropriate for nonprescription use if we are able to ensure access to resources that will help patients determine if the medicine is right for them. These are the products that we will carefully consider for this innovative pathway.”
New tools include digital health technologies, such as mobile apps and online programs that ask users a set of questions to help them pick the right drugs.
Gottlieb cited cholesterol-lowering drugs and naloxone products, used to treat opioid overdoses, as examples of drugs that potentially could be made available to consumers without a prescription.
“We see today’s draft guidance as a first step as drug developers begin to study products that might be considered for marketing without a prescription,” he said.