The FDA is trying to figure out if more prescription meds can be sold OTC.
With the rising cost of healthcare in the United States, the federal government is taking its “first steps” at putting more decisions into the hands of the patients.
The U.S. Food and Drug Administration (FDA) is asking drug companies to look at their prescription drugs and consider which ones might be capable of being sold over the counter (OTC).
It will also affect how a drug can be marketed. Instead of ads telling you to ask your doctor if a certain drug can work for you, you can just snag it off the shelf.
Last week, FDA commissioner Dr. Scott Gottlieb said that some drugs are appropriate for nonprescription use for patients, “empowering them to self-treat common conditions and potentially some chronic conditions.”
“Our hope is that the steps we’re taking to advance this new, more modern framework will contribute to lower costs for our healthcare 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,” Gottlieb said in his
Citing the cost and time it takes to get a prescription filled, the FDA issued a “draft guidance” — an initial step in testing the waters.
It advised two different ways that drugs currently only available with a prescription could be sold over the counter. The first would be a new labeling system that would better inform patients.
The second would be the “implementation of additional conditions so that consumers appropriately self-select and use the product.”
Both of these approaches would be aided with the use of technology, such as mobile apps or other tools. But the FDA says specific details — namely the appropriateness of any approach from bringing a drug from prescription to OTC — would depend on the drug.
“But it’s important we’re clear that we are not proposing a change in the evidentiary standard needed for a product to be approved by the FDA as nonprescription,” Gottlieb said. “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.”
The draft guidance, if implemented, wouldn’t have any legal binding on the FDA or any other public or private entity. Instead, it would act as a document that represents the “current thinking” of the FDA on the subject.
In his announcement, Gottlieb specifically mentioned two types of drugs that could make the OTC list: those that manage high cholesterol and naloxone. Naloxone, with the brand-name Narcan, is the injectable drug that immediately reverses the effects of an opioid overdose.
Other drugs could include high blood pressure medications and those to treat diabetes.
Many people are also hoping that birth control pills may finally be available over the counter, much like the Plan B emergency contraception pill.
But the FDA didn’t specify which drugs could fall under the new over-the-counter guidelines.
Gottlieb said that the ultimate goal of addressing and possibly altering the FDA’s current regulations on OTC drugs “is to help facilitate a market that is more competitive, enables greater access to medical products, empowers consumers in their healthcare decisions, and provides more affordable options for Americans.”
While the FDA is seeking input on how exactly to address and accomplish this, some have argued for years that it won’t make healthcare more affordable but would instead shift more of the financial responsibility onto the patient.
Or, as one doctor said, by decreasing the role of medical professionals in the U.S. healthcare system, it could burden patients with more cost.
Dr. Matthew Mintz, an internist practicing in Bethesda, Maryland, is skeptical of the plan.
“They will likely pay more for the same meds since they are OTC instead of prescription,” Mintz recently told Healthline. “Also, depending on which medicines are chosen, there could be harm to patients due to incorrect usage.”
He thinks that instead of improving access to primary care physicians or finding real ways of reducing healthcare costs, the government wants to take doctors out of the equation and shift costs to patients.
There are also the financial implications for both the patient and the drug makers.
One concern is whether insurance companies would cover these new OTC drugs and another is if pharmaceutical companies would have the incentive to do so.
“They will need to lower their cost to get the prices acceptable to the OTC market,” Mintz said.
While the FDA says that it doesn’t have control over the price of drugs, Mintz said the United States needs to join the rest of the world.
“We need regulations that control the prices of drugs like every other country in the world,” he said.
The FDA is currently seeking input from medical professionals and drug makers on its website.
As of Wednesday, a week after the draft guidance was released, no public comments have been posted. Comments are due to the FDA by Sept. 17.