Smartphones have become ubiquitous today. Need a cab? There’s an app (or several) for that. Need to order groceries to be delivered? There’s an app for that. Need to see who just rang your doorbell? Yes, there’s an app for that too. The United States Food and Drug Administration (FDA) may be taking steps to allow patients with chronic diseases access to drugs with their cell phones, too.
Sometime in 2019, health officials are expected to propose a plan that would limit the need for patients to interact with their doctors and instead allow them to use an app on their cell phone to determine their need for certain prescription drugs and then give them a code or ticket to pick it up at their local pharmacy.
FDA Commissioner Scott Gottlieb has previously acknowledged the benefits of smartphones and in-store video kiosks as a way to modernize and streamline the healthcare system. In so doing, it may help enable a switch from prescription-only drugs to over-the-counter medications, which would provide greater access to life-saving drugs and potentially boost brand-name manufacturers.
“The over-the-counter product can breathe new life into the product commercially,” says Christopher Stomberg, an associate director at NERA Economic Consulting who specializes in health care and life sciences. “The over-the-counter product, what it introduces for the manufacturers, is the potential to reach some of these populations where the generic prescription may not be able to reach.”
According to the U.S. Centers for Disease Control and Prevention, roughly 45 percent of the 78 million U.S. adults who might benefit from cholesterol medication don’t take it. If statins were available over the counter, more than 68,000 heart- and stroke-related deaths, plus hundreds of thousands of major coronary events, would be averted over the course of ten years, Stomberg and others wrote in the American Journal of Managed Care in 2016.
In addition to medications for cholesterol, the concept expected to be released by the FDA could also expand to medicines for high blood pressure, migraines, and asthma.
Potential Barriers
Health insurance has not traditionally paid for or covered the costs of over-the-counter medications. However, as part of an incentive for branded drugmakers to make the switch, one idea is that they are eligible for up to three years of selling their over-the-counter prescription free of any generic competition.
As a ray of hope, over twenty prescription drugs have made the switch to over-the-counter in recent years, including medications for allergies and heartburn. However, the sticking point for statins and asthma inhalers has been studies that raised uncertainties about the ability of patients to accurately determine on their own if they actually need them. This is where the smartphone app comes into play.
GlaxoSmithKline Plc (GSK) switched nine drugs from prescription to over-the-counter status in recent years, including Alli (weight management), Prevacid (indigestion), and Flonase (allergies). “The goal is appropriate increased access for patients,” says Richard Slater, head of research and development at GSK’s consumer health care business. “Technology can make that quite frictionless, quite a user-friendly experience, while still maintaining that quality, safety, and efficacy.”
GSK is assessing what kind of technology may work for bringing chronic-condition treatments over the counter and what categories of drugs might be ripe for using the technology, Slater says.
The process to switch a prescription drug to nonprescription status can take several years, as there may be a need for trials to determine if patients can understand when they might need a drug and whether they can use it appropriately.
Conclusion
This is certainly an interesting concept and it is worth keeping an eye on in the coming months for an announcement by the FDA, and then subsequent changes and reactions by pharmaceutical companies.