What the FDA Gets Wrong About Drug Ads

There are only two countries in the world where drug manufacturers are allowed to advertise their products directly to consumers: the United States and New Zealand. Drug companies in the United States, for example, are spending $4 billion a year on TV ads alone.

The typical TV drug ad these days usually touts the benefi ts of a drug—maybe with a lot of singing and dancing—and closes with a brief rapid-fire list of possible side effects, as parodied on Saturday Night Live.

That’s about to change. After 15 years of studying the matter, the U.S. Food and Drug Administration (FDA) is going to require the ads to show less about the benefits and more about the side effects and risks. A new bill in Congress would impose similar restrictions on social media platforms.

Under a Trump administration, regulations could become even harsher. Robert F. Kennedy, Jr. (Donald Trump’s pick to head Health and Human Services) wants to ban drug ads completely. Kennedy claims that drug ads are such an important source of revenue for the networks that they influence what is allowed on the regular programming (e.g., avoiding criticism of Pharma).

Here is what the regulators and would-be regulators are missing. Our most important health care problem is not that people are taking too many prescription drugs. They are taking too few.

Why Drug Advertising Is Good

The social value of drug advertising is that it alerts patients to the fact that there is a possible remedy for a chronic illness. The payoff is that the viewer might seek medical advice from a doctor and get a prescription, where appropriate.

There is no social value in ads that list risks and negative side effects. The information will always be too clipped to be understandable, it won’t be remembered anyway, and it is useless unless a doctor finds that the patient is a candidate for the drug.

The time to discuss side effects is when patients are under a doctor’s care.

Studies show that we get our best return in medicine on drugs. Per dollar spent, the return on investing in drug therapy is much higher than what w e are getting from investing in doctor care or hospital therapies. For example, Columbia University’s Frank Lichtenberg has estimated that three quarters of the increase in life expectancy that we’ve enjoyed in recent decades is the sole result of our adoption of modern drugs.

Yet we are underinvesting in drugs, as reflected in undertreatment rates for chronic illness in this country.

Take diabetes. Studies show that only 2.4% of people with prediabetes receive a prescription for metformin (the preferred treatment) within a year of their diagnosis. Even among obese patients, the figure is only 10.4%. Three years after an initial diagnosis, when the patient is even more susceptible to the disease, the treatment rate is still surprisingly low: 3.9% overall and only 14% for obese patients.

Or consider hypertension. One out of every four patients with the problem is not being treated at all. And only half of adults with hypertension have their blood pressure under control.

Almost as bad as no t getting the prescription people need is not taking the drug once it is in hand. Both problems arise for similar reasons.

Nearly half of all Americans suffer from at least one ongoing or chronic health condition, and nearly half of these are not adhering to a needed drug regime.

There are an estimated 125,000 deaths per year in the United States due to medication nonadherence. Further, an estimated 33% to 69% of medication-related hospital admissions are due to poor adherence. The total cost estimates for medication nonadherence range from $100 billion to $300 billion every year, when both direct and indirect costs are included.

Nonadherence and failure to get a prescription in the first place occur for a variety of reasons: lack of information, misinformation and unfounded fear—all of which can be combatted with more, not less, information.

Current Rules Restrict Use of Valuable Drugs

Not only are the new rules ill-advised, the ones in force right now are already causing considerable harm. That’s because a drug prescribed by doctors—no matter how useful and widespread the application—cannot be advertised, even to doctors themselves, unless the use has been FDA- approved.

Once a drug has been approved for one use by the FDA, doctors may find that it has other uses—even though the effectiveness of these other uses has never been studied through an FDA-approved trial. These are called “off label” uses.

For example, one study found that approximately 80% of oncologists had prescribed medications off-label in treating cancer patients. Another study found that a bout half of chemotherapy drugs are administered for conditions not specified on their FDA-approved labels. For pediatric care, physicians order at least one off-label drug in 18.5% of office visits. The practice is most common in neonate cancer patients, with 83% of visits involving an off-label prescription.

For the population as a whole, about 10% to 20% of all prescriptions are for off-label uses.

It is hard to exaggerate how unreasonable FDA regulations are in this regard. Even if researchers publish research findings on the off-label use of a drug in the New England Journal of Medicine, a drug company is not allowed to share that article with doctors. If they do, the drug company’s decision makers could wind up in prison!

When it comes to the potential of drugs to treat chronic conditions, more information is better than less. And this is especially true in an age when there is so much misinformation on the internet.

We should let people learn about the positive benefits of drugs from TV ads and other venues. That will encourage them to seek a doctor’s counsel. The doctor’s office is the place where risks and side effects should be discussed.