The average American neither can nor should have to be aware of the FDA’s vast library of commandments on what they shall or shall not do. Is it time for Congress to take a hard look at what the FDA’s role should be in the information age? The solution almost certainly isn’t going to be doling out more resources and more authority to the FDA to control speech. Instead, we need to find new ways to get faster and cheaper approvals of new drugs and devices to ensure that all Americans have access to the medical care that best fits their needs.
Kim Kardashian has 43.5 million followers on Instagram and 34.5 million on Twitter. Recent tweets include messages like, “My good friend @BySimoneCamile has the cutest bags & they are on sale!!!!” That product promotion may have been okay, but she apparently crossed the line with an Instagram post about a drug that helped her with morning sickness. While the cutest bag sale may have been useful for some, advising her millions of followers that a drug helped her overcome morning sickness caused the United States Food and Drug Administration to become apoplectic.
The FDA objected on the grounds that Kardashian was paid to promote the drug, and by not disclosing the potential side effects, she violated FDA regulations. But the real issue is that FDA’s laws governing drugs are nearly 60 years old (and 40 years old for medical devices), which long predate the dawn of the internet. In this age of communicating to the masses at light speed with a few keystrokes, Kardashian’s statements are instantly part of the vast web of information now available to the public.
Given that there are 175,000 pages of regulations with well over one million commandments — and quite a few those belong to the FDA — it’s not surprising that Kardashian was unaware of not just the penchant for control of information but the authority as well. FDA regulates all sorts of communications about drugs, not only what is on the label and the patient package inserts but also “brochures, reprints of scientific papers and press releases.” Oh, and now it’s including Hollywood tweets.
Dr. Jennifer Niebyl notes that as many as 90% of all women get morning sickness when pregnant, which includes nausea and vomiting. The physician goes on to say that as every woman and every pregnancy is different, there’s no one-size-fits–all remedy. After seeing the advice of their favorite celebrity, some women may Google more information, but others might just talk to their doctor. Either way, a physician must prescribe it.
In a further attempt to control medication advertising, the FDA ensures that manufacturers cannot advertise new uses for drugs no matter how helpful those uses. For example, the anti-infection drug Bacitracin is often prescribed for children, and 97% of those uses are not on the FDA-approved label. Patients and physicians living in less urban areas may not have access to information that you would find in a large urban hospital, which would let them know about important new applications for medication, although a recent court case may start to change that.
Trying to exert control over every bit and byte of information by a centralized agency is, at the same time, both quaint and counterproductive. We need to allow the flow of information to be unrestricted. After all, we are beginning to see wonderful things happen as patient groups with every imaginable condition share their experiences about what works — and what doesn’t — with each other.
The average American neither can nor should have to be aware of the FDA’s vast library of commandments on what they shall or shall not do. Is it time for Congress to take a hard look at what the FDA’s role should be in the information age? The solution almost certainly isn’t going to be doling out more resources and more authority to the FDA to control speech. Instead, we need to find new ways to get faster and cheaper approvals of new drugs and devices to ensure that all Americans have access to the medical care that best fits their needs.