If your focus is on food, it’s easy to forget sometimes that the agency that regulates a significant amount of U.S. food—the FDA—is also in charge of the nation’s drug supply. What happens on the drug side of the house isn’t usually relevant to food producers or marketers, but sometimes an event in drugs offers some insight into how the agency is thinking about big issues.
One of those events seems to be in the offing. According to the Federal Register, FDA plans to convene a hearing to discuss its policies on how manufacturers are allowed to talk about “off-label” uses of already-approved drugs and medical devices. The details are complex, but the big thing to notice is that FDA is revisiting an incredibly contentious conflict: free speech versus regulation.
The basic issue is: When FDA approves a drug to go on the market, it approves it only for specific uses—a specific disease, a specific kind of patient, and so forth. Doctors, however, are mostly free to use drugs as they see fit. And they do. It’s estimated that more than 20 percent of U.S. prescriptions are off-label, and in some fields like pediatrics and oncology the rate is much higher.
The most astonishing example of a drug that grew through off-label use is Botox, which was first approved for treating one particular kind of facial wrinkle and then expanded to dozens of uses: migraines, excessive perspiration, eyelid spasms, chronic pain, certain jaw disorders, and on and on. For some of these uses, the manufacturer, Allergan, presented data to the FDA that supported the use and got approval for a new “indication” (to use the industry’s term). Others are still unapproved.
But here’s the tricky part (and trust me, we’ll be getting around to food before you know it): Though doctors can and do use drugs off-label, and though they can and do write medical journal articles about the new uses, the manufacturer is prohibited from mentioning them. If a doctor asks a drug rep about an off-label use, the drug rep can’t answer, but instead has to refer the doctor to a different part of the company, which is bound by elaborate rules in how it replies.
A legal prohibition on providing truthful information about a product? Sounds like that would violate the First Amendment, doesn’t it? Here’s how a group of supplement manufacturers put it in testimony before FDA a few years ago: “FDA now has the dubious distinction of being that agency within the federal government that suppresses more protected speech than any other.” Perhaps an exaggeration, but one with some truth behind it. The Supreme Court thought so, too, and in a series of court decisions in the early 2000s ordered FDA to change its ways. In practice, however, things went on as before until this year, when FDA was forced to settle with a pair of pharma companies, basically allowing them to market off-label.
On the food side, things work differently, but it’s still true that FDA gets to decide what companies are allowed to say about their products. In many ways, that is a good thing. (According to Philip Hiltz, when labeling laws first came up for discussion in the 1890s, jelly manufacturers complained that they would be ruined if, as a result of such disclosures, they had to put actual fruit in their products.) But it’s a system that is constantly under fire, especially in recent years, when many people—rightly or wrongly—have grown uncomfortable with the idea of a government agency that evaluates scientific evidence to decide what’s good enough (Omega-3’s are good for your heart) and what’s not (vaccines cause autism). And the agency has opened the door to additional health claims about foods by creating a system of disclaimers. (An example: “As part of a well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, Vitamin B6 and Vitamin B12 may reduce the risk of vascular disease. FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive.”) But there’s pretty persuasive evidence that disclaimers don’t work: Consumers don’t actually make distinctions between strong and weak claims, even when the difference is pointed out to them.
It’s not a good situation, and it’s hard to see how it can be made better. Part of the problem, of course, is that health claims printed on specific food products are mostly the worst sort of canard. Yes, we all need a good diet, but despite what the Internet tells us all day every day, we aren’t likely to get there by pursuing fads and looking at nutrients in isolation. Remember the catastrophe of “low fat” food made palatable by tons of added sugar? We’re undoubtedly doing something just as stupid today—we just aren’t sure what yet.
By training and experience, I’m a hardline First Amendment kind of guy. But only when it comes to people. Much less so for corporations. I do believe in vigorous communication about products. But I’ve seen too many lies to think that companies should have a free hand in how they describe foods, medicines, financial services, auto leasing contracts, environmental impacts . . . actually anything at all. We can all agree that companies should tell the truth. But who decides?
Here’s a prediction: If there’s a big change in FDA’s position on off-label drug marketing, it’s only a matter of time before there’s a serious First Amendment suit on the food side, probably coming from a supplement manufacturer. (Remember, under the law, they make food rather than drugs, but they market their products based on real or supposed health benefits, which they’d love to be able to put in their labels and ads without restriction.) And FDA, in today’s climate, could lose.
Such a decision might make life simpler for some food manufacturers. It would give more latitude to companies that simply don’t share prevailing attitudes about food. And it will open the floodgates to a level of mendacity we haven’t seen in the American food marketplace for a century.