The Food and Drug Administration (FDA) has released new guidance for drug developers that could potentially lead to the approval of a wider range of nonprescription drug products, allowing patients to “self-treat” some acute conditions and possibly chronic ones as well.
“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,” said FDA Commissioner Scott Gottlieb, MD. Resources such as mobile applications, suggested Gottlieb, could be used by an individual to determine whether a certain treatment is appropriate for them prior to being able to actually purchase it.
The draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the New Drug Application (NDA) process and “is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription,” said Gottlieb in a press statement. For example, a manufacturer that has a cholesterol-lowering drug would need to develop an innovative approach to increase “correct self-selection” and “accurate use” in the nonprescription setting. Through appropriate studies, the manufacturer would have to prove that the approach works, and would then submit an application to the Agency for approval.
While many prescription drugs require a professional diagnosis and oversight, Gottlieb hopes that increasing the availability of certain products that would otherwise be available only by prescription will provide greater empowerment for consumers. “Our ultimate goal with modernizing our regulatory framework for nonprescription drugs is to help facilitate a market that is more competitive, enables greater access to medical products, empowers consumers in their health care decisions, and provides more affordable options for Americans.”
For more information visit FDA.gov.