– A draft guidance from FDA will help patients navigate over-the-counter (OTC) drug alternatives for some of their usual, prescription chronic disease management drugs. Ideally, this will promote patient choice in their own medications and control some of the out-of-pocket drug costs patients face.
“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,” wrote FDA Commissioner Scott Gottlieb in a statement announcing the guidance.
“Our hope is that the steps we’re taking to advance this new, more modern framework will contribute to lower costs for our health care system overall and provide greater efficiency and empowerment for consumers by increasing the availability of certain products that would otherwise be available only by prescription.”
Specifically, FDA wants to provide the support to help patients choose between a traditional, prescription medication and an OTC medication. Prescription medications for chronic disease management tend to be extremely costly, and in many cases, those costs can be prohibitive for patients.
Data shows that about 14 percent of patients skip filling a prescription because of cost.
Driving use of OTC drugs in place of costlier prescriptions is not a panacea, Gottlieb added as a caveat. Directing patients to a more accessible and less costly version of a narcotic is not a viable solution, for example.
“Clearly, not all prescription drugs can or should be available directly to consumers,” Gottlieb explained. “Many require a professional diagnosis and oversight to ensure the benefits of use outweigh the risks. 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.”
mHealth and other patient-facing technologies could be extremely helpful in directing patients to potential, OTC replacements for their prescription medications. For example, an mHealth app that includes a questionnaire about patient lifestyle habits and medication needs could display a set of options that could fit patient preferences.
The tool could then support the patient in self-selection of a chronic disease management medication.
There will be important safety considerations, FDA acknowledged. Currently, over-the-counter drugs receive high scrutiny from FDA during the drug approval process. This is because these medications need to be safe enough to be user-directed.
FDA will need to supplement those safety efforts, Gottlieb asserted. Use instructions, otherwise known as Drug Facts Labeling (DFL), will need additional information either in the form of added labeling or a patient education app.
Tools targeted at helping patients make decisions between OTC and prescription medications can also have added criteria that create more patient safety around an OTC drug. Adding more specific criteria will ensure only patients who truly need an OTC drug have been directed toward it.
Gottlieb imagines a revamped drug approval process to drive more patient education with an OTC drug, he said. The process will likely begin with a drug manufacturer with both a prescription and OTC option for a certain medication.
From there, the manufacturer will need to design the patient decision-making mechanism, as well as the additional patient education protocol. Those will need to be use-tested to prove their success. The manufacturer can then submit an approval application to FDA.
None of this is to say FDA will be relaxing its standards for approving non-prescription medications. This will still be a rigorous process targeted at driving patient safety.
“As we move into making this a reality, the FDA will ensure that products considered under this framework receive a robust scientific review to ensure they can be used safely by patients,” Gottlieb wrote.
Instead, FDA is trying to make it easier for patients to access and use these drugs for their chronic care management plans.
“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,” Gottlieb said.
These patient-centered efforts from FDA align with the latest drug announcements from HHS, according to agency Secretary Alex Azar. Recently, HHS published its drug pricing blueprint, which called for reducing out-of-pocket drug costs for patients and better patient access to drugs.
“FDA’s announcement is another step in our efforts to deliver on President Trump’s blueprint to put American patients first,” Azar wrote in a statement reacting to FDA’s guidance.
“The agency’s new guidance will offer innovative ways for drug manufacturers to give patients over-the-counter access to drugs they need to treat or manage conditions, offering consumers greater convenience and more affordable options by not having to obtain a prescription,” Azar added. “We are proud of the work Commissioner Scott Gottlieb and everyone at FDA are doing to advance patients’ access to treatments at a lower cost, while always maintaining the agency’s gold standard for safety and effectiveness.”