18 July 2018 - Deborah Wilkes
Draft guidance from the US Food and Drug Administration (FDA) paves the way for companies switching medicines from prescription to non-prescription status to make use of new types of labelling and digital health technologies.
The draft guidance says companies can propose innovative approaches when the Drug Facts Labeling (DFL) is not sufficient to ensure a product is safe and effective for use as a non-prescription medicine.
According to the draft guidance, new types of labelling could include information leaflets or other documents inside the product packaging, text or images on a video display, and information displayed on websites. Statements or questions in a mobile app would also be acceptable.
Furthermore, the draft guidance suggests companies could develop a self-selection test in a mobile app or a video describing how to use the non-prescription medicine appropriately.
The US Consumer Healthcare Products Association (CHPA) welcomed the draft guidance. Considering advances in digital health technology such as apps, new additional types of labelling or other innovations as part of the new drug application (NDA) process for non-prescription medicines was a welcome modernisation of the regulatory framework, said the CHPA.
The industry association noted that manufacturers had been talking to the FDA about innovative approaches for several years.
FDA commissioner Scott Gottlieb stressed that not all prescription drugs could be available directly to consumers. "Many require a professional diagnosis and oversight to ensure the benefits of use outweigh the risks," he said.
However, added Gottlieb, select types of drugs were "appropriate for non-prescription use if we are able to ensure access to resources that will help patients determine if the medicine is right for them".
Digital health technologies
Gottlieb said digital health technologies, for example, could support consumers in appropriately and safely self-selecting and using certain medicines. A set of questions answered on a mobile medical app, he added, could help someone determine whether the use of a non-prescription drug was appropriate for them prior to being able to purchase that drug.
Commenting on how the process would work, Gottlieb said "a sponsor – for example one that has a prescription cholesterol-lowering drug or a prescription naloxone product – could develop one of these innovative approaches to increase the likelihood of correct self-selection and accurate use of their product in the non-prescription setting".
"After performing appropriate studies demonstrating that the novel approach works as intended, in other words that consumers can safely use the drug without a prescription and associated supervision of a healthcare professional," he added, "the sponsor could submit an application for FDA consideration for non-prescription status for the product."
In 2015, Pfizer "terminated" its programme to switch the cholesterol-lowering drug Lipitor (atorvastatin) from prescription-to-OTC status in the US.
The company said its actual-use trial for Lipitor in a simulated OTC setting had failed to meet the primary objective. Pfizer explained that the study had not demonstrated "patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, take appropriate action based on their test results".
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