Trump’s FDA Might Greenlight Drug-Prescribing Apps for Chronic Ailments

(Bloomberg Businessweek) -- Smartphones have revolutionized many aspects of modern life, from trading stocks to taking photos to hailing a cab. The next big task for the diminutive devices may be a more serious one: determining whether patients would benefit from treatments for chronic conditions such as high blood pressure and cholesterol and then granting them access to such drugs.

U.S. health officials expect to propose in the first half of 2019 a plan that would limit the need for potentially millions of people to interact with a doctor and instead allow them to use their phone to determine their need for, say, Pfizer Inc.'s cholesterol-fighter Lipitor—and then give them a code or ticket to pick it up on their pharmacy's shelf, next to the aspirin and cough syrup.

Food and Drug Administration Commissioner Scott Gottlieb sees smartphones and technologies such as in-store video kiosks as a way to enable the switch from prescription-only to over-the-counter sales for more drugs. This could give consumers easier access to crucial medications and be a boost for branded pharmaceutical companies that might otherwise lose revenue to low-cost generic competition. “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.”

Those could be people who don't want to see a doctor or those without insurance who balk at the expense of a visit, Stomberg says. About 45 percent of the 78 million U.S. adults who might benefit from cholesterol medication don't take it, says the U.S. Centers for Disease Control and Prevention. 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 10 years, Stomberg and other health policy experts wrote in the American Journal of Managed Care in 2016.

Besides cholesterol pills, the new rules could cover medicines for high blood pressure, migraines, and asthma—maladies that affect millions and offer plenty of data about existing medicines' efficacy and safety. There's also a shot at untapped revenue for branded drugmakers who successfully reach the millions of potential patients who aren't receiving prescriptions from a doctor. Already, sales of cholesterol-lowering treatments alone totaled $10 billion in 2016, says Bloomberg Intelligence.

There is some risk for branded drug manufacturers as insurance generally doesn't cover over-the-counter medications. As an incentive for drugmakers to make the switch, they can be eligible for up to three years of selling their over-the-counter treatment free of generic competition. Gottlieb says some companies have already submitted applications to switch a handful of medicines. “It's obviously early days,” he says. “We're having a lot of conversations, so we'll see the pipeline build.”

More than 20 prescription drugs have made the over-the-counter switch in recent years, including allergy and heartburn drugs. The sticking point for treatments such as statins and asthma inhalers has been studies that voiced uncertainty about the ability of millions of Americans to accurately determine on their own whether they needed them.

Enter smartphone apps, which FDA officials believe could be more effective than printed materials in helping consumers determine if they need a drug. “Patients want affordable options,” Gottlieb says. “It's expensive and hard to go to the doctor. We want to facilitate compliance [with a medication regimen], and this is one way.”

GlaxoSmithKline Plc switched nine drugs with annual sales of more than $100 million from prescription to over-the-counter status in recent years, including Alli for weight management, Prevacid for indigestion, and Flonase for allergies, according to spokeswoman Caitlin Kormann. “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 an average of about four or five years, including trials to determine if patients can understand when they might need a drug and whether they can use it appropriately.

Pfizer has studied whether it could switch Lipitor, which was once the world's top-selling drug for high cholesterol, to over-the-counter status but abandoned the endeavor in 2015 after it decided patients couldn't use the medicine correctly without a doctor's help. It's unclear if the company could consider revisiting the idea. Pfizer declined to comment for this article.

Also, while consumers might gain greater access to drugs if the FDA goes through with its change, over-the-counter drugs could take a bigger bite out of patients' wallets, since insurance doesn't typically cover the off-the-shelf medicines. Mariell Jessup, chief science and medical officer at the American Heart Association, gives an example of how this is a problem for some patients using antacids. Versions of Johnson & Johnson's Pepcid, as well as generic competitors, are available over the counter, while a stronger version requires a prescription, she says. “I've had many patients say ‘Give me a prescription because I can't get them cheaper over the counter,' ” Jessup says of certain antacids like Pepcid called H2 blockers. “It's not a simple issue.”

To contact the editor responsible for this story: James Ellis at jellis27@bloomberg.net, Rick Schine

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