U.S. regulators proposed new guidelines Tuesday to make it easier for some common medicines to be sold without prescriptions -- and more convenient for consumers to get them.
The Food and Drug Administration is evaluating ways to make sure patients don't take inappropriate over-the-counter drugs, Commissioner Scott Gottlieb said in a statement. That could include adding information to the packaging label and offering online questionnaires to help people decide if a drug is right for them.
Patients could answer questions on a mobile-phone app to help determine whether they should be able to access a medication without a prescription.
Drugmakers would have to do studies showing that those strategies allow consumers to safely pick drugs and use it without medical supervision.
The agency will take comments from drugmakers, medical groups and the public before issuing final rules, a process that usually takes many months.
"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," Gottlieb said.
The proposal is meant to help companies start thinking about how they might seek approval for such drug sales. The move isn't expected to lower the bar for shifting prescription drugs to over-the-counter status, Gottlieb said.
Many widely used nonprescription drugs originally were available only by prescription, requiring a doctor visit and sometimes coverage approval from insurers.
Examples include many pain relievers, allergy treatment Claritin, heartburn remedy Prilosec, Imodium for diarrhea and Monistat for yeast infections. They're generally much cheaper than the higher-dose prescription versions.
"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," Gottlieb said.
While nonprescription drugs are less expensive, they generally aren't covered by health insurance.
In the past, the FDA rejected some proposed switches of prescription drugs to over-the-counter status. Those include three early cholesterol drugs, with the FDA ruling that those would be unsafe, partly because their use requires periodic blood testing. However, Gottlieb's statement mentions cholesterol-lowering drugs as over-the-counter candidates, along with the opioid-overdose drug Narcan, which is already sold without a prescription in some places.
The FDA explored the idea of a "behind-the-counter" designation in 2007 that would have required interaction with pharmacists. The Government Accountability Office in a 2009 report on the proposal asked whether consumers would end up paying more for their drugs since nonprescription medications typically aren't covered by insurance.
The idea resurfaced in 2012 when the FDA evaluated whether to reclassify treatments for high blood pressure, cholesterol, migraines and asthma as nonprescription. The market for such medicines is vast: Global sales of cholesterol-lowering drugs totaled $7.33 billion last year, according to Bloomberg Intelligence.
Slightly more than half of U.S. adults, or about 43 million people, who need cholesterol medication are taking it, according to the Centers for Disease Control and Prevention. About 75 million Americans, or one out of every three adults, have high blood pressure, though only about half of them have the condition under control, according to the CDC.
Information for this article was contributed by Linda A. Johnson of The Associated Press and by Anna Edney of Bloomberg News.
Business on 07/18/2018