SAM URETSKY

“Since stepping into the helm at the Department of Health and Human Services, Robert F. Kennedy Jr. has done his best to challenge traditional medicine. He has loosened vaccine recommendations for children and pregnant women, peddled baseless claims about the causes of chronic diseases, and championed alternative therapies such as ‘healing farms.’

“Now, he is considering two proposals that would make it much more difficult for companies to air television advertisements promoting their drugs to consumers. One would require that ads include longer warnings about side effects, making them more expensive to run. The other would prevent drug companies from deducting advertising costs as business expenses for tax purposes.” — Editorial Board, Washington Post July 28, 2025

“The advertising quack who wearies with tales of countless cures/ His teeth I’ve enacted shall all be extracted by terrified amateurs.” — W. S. Gilbert (The Mikado)

For decades the federal regulations have tried to make drugs safer and less expensive. The first attempt to regulate drug safety was the Pure Food and Drug Act of 1906, but that was primarily a truth in labeling law which made it it illegal to sell products that were “adulterated” or “misbranded.” The Food, Drug and Cosmetic Act was passed in 1938 expanded the scope and responsibilities of the Food and Drug Administration, which was essentially a guarantee of drug safety. The Durham-Humphrey amendment of 1951 strengthened the safety provisions and also, by requiring a prescription from a physician or other licensed practitioner, controlled the cost of drugs.

The rules for drug prescribing and dispensing have been tightened considerably since then. Physicians may need to complete an educational course or be certified in a specific REMS program. (Risk Evaluation and Mitigation Strategies.) Prescribers and even pharmacies may be required to enroll in a registry and follow specific protocols before the drug can be prescribed or dispensed. For example, clozapine, an antipsychotic medication carries the risk of a dangerous drop in white blood cells. Prescribers must be certified in the Clozapine REMS program. Some states have their own special requirements for some drugs.

There are requirements for drug advertising as well. The advertisements must contain the advice “ask your doctor if (insert the name of the drug) is right for you.” The drug must be sold to the pharmacy by a “full disclosure.” which is probably not all that much use, since it’s also known as the “package insert.” This is a sheet with information about the drug, but since it’s included with the package that’s sent to the pharmacy, it doesn’t reach the prescriber. It was a sincere attempt to make drugs safer, but it usually winds up in the pharmacy waste basket. Still, ads for prescription drugs printed in medical journals must have the package insert printed with the ad. Look at an internet ad for a prescription medication and there will be two sections, one for patients (or prospective patients) and another for US healthcare providers. The PPI (patient package insert) is easier to understand and is generally given to the patient with the filled prescription. 

As for the price of drugs, the price may be controlled by the health insurer, which has its own formulary, a list of drugs that are covered by insurance. The insurer decides what drug will be covered and which won’t.

But advertising directly to patients is not necessarily a bad thing, since patients don’t know what their symptoms are – serious or not serious. For example, a heart attack in a woman is frequently different from a heart attack in a man. Men are more likely to have pain in the left arm, while women may have symptoms of gastrointestinal upset and fatigue.  By giving information about what to look out for, patients may know whether to take an OTC (non-prescription) drug, or go to an MD or even emergency room.

The challenge is to have access to a physician. More and more physicians are choosing to join groups with annual fees for patients, and will not see Medicaid patients (patients whose coverage is based on income.) KFF.org reported, “About 17 Million More People Could be Uninsured due to the Big Beautiful Bill and other Policy Changes.”

Drug advertisements aimed at patients may, just may, increase the number of people recognizing the need for qualified medical attention. At least direct-to-patient advertising can give information about when an MD is essential at a price that everybody can afford.

Sam Uretsky is a writer and pharmacist living in Louisville, Ky.

Email sam.uretsky@gmail.com