People’s Pharmacy | The FDA wants more OTC drugs
A long time ago, almost all medicines were sold without prescriptions. General stores sold old-time favorites for headaches, hangovers, back pain and constipation.
Traveling medicine shows sold a variety of patent medicines off the back of the wagon. The term “snake oil” was used to describe a cure-all of dubious origins and effectiveness.
In 1938 Congress passed the Federal Food, Drug, and Cosmetic Act (FD&C Act) that gave the Food and Drug Administration authority to regulate drugs and make sure they were safe. In 1951 an amendment divided drugs into two categories. Prescription drugs were those considered to need professional supervision. Everything else could be sold over the counter (OTC).
In 1962 another act of Congress required that all drugs, including OTC products, would have to be both safe and effective. In those days, less than half of the products sold without prescriptions met those standards.
Since then, many popular prescription products have jumped from one side of the pharmacy counter to the other. Some of the most popular switches include pain relievers such as ibuprofen (Advil, Motrin IB) or naproxen (Aleve). The antihistamine diphenhydramine (Benadryl) is another example. Even acetaminophen (Tylenol) was once available only by prescription.
In recent years, drug makers have brought other very popular prescription medicines to the aisles of supermarkets and convenience stores as well as pharmacies. They include heartburn medications such as omeprazole (Prilosec OTC) and esomeprazole (Nexium 24HR). Steroid nasal sprays like fluticasone (Flonase) or triamcinolone (Nasacort) were once only available with a physician’s prescription. Now, however, you can get them almost anywhere.
Now FDA Commissioner Dr. Marty Makary wants to make many more drugs available without prescription. He is on the record saying that “everything should be over the counter, not requiring a prescription, unless it’s unsafe, unless you need laboratory tests to monitor how it’s being received by your body, or if it can used for some nefarious purpose, or it’s addictive.”
Dr. Makary wants to reduce red tape and make it easier for drug companies to take their popular products OTC. One of his pet projects is over-the-counter access to vaginal estrogen. He’s been quoted: “There has been tremendous demand for hormone replacement therapy for postmenopausal women; we’ve been tracking it closely.”
Here at The People’s Pharmacy, we have long been advocates for informed self-care. The problem is that many people assume OTC drugs are inherently safe. We don’t think that’s always the case. That’s why we would like to see a third category of medicines. They would not require a doctor’s prescription, but patients would have to consult pharmacists before they could make a purchase.
Many other countries have this category. In some places pharmacists can dispense cholesterol-lowering drugs, adrenaline injectors for severe allergic reactions or even antiviral medicines to treat a herpes outbreak.
The FDA has never been enthusiastic about this behind-the-counter category. There are, however, a few drugs that are already sold this way in the US. One is pseudoephedrine (Sudafed). Another is Plan B Emergency Contraceptive. In addition, insulin can be purchased without a prescription but with a pharmacist’s advice in 49 states.
Pharmacists are highly trained health professionals. The more they can be involved in decisions about medications, the safer people will be.
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Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. Their syndicated radio show can be heard on public radio. In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of this newspaper or e-mail them via their Web site: www.PeoplesPharmacy.com.
This story was originally published April 17, 2026 at 1:00 AM with the headline "People’s Pharmacy | The FDA wants more OTC drugs."