In early 2014, the Food and Drug Administration (FDA) issued proposed guidance for pharmaceutical companies who elect to use Twitter or paid search to promote their drugs and medical devices – and Big Pharma is starting to fight back. Are their arguments valid? Are tweets protected under the First Amendment? Is the FDA contradicting itself? Or has the pharmaceutical industry just gone too far this time? Let’s take a look.
What Is the FDA Asking?
The FDA’s guidance on paid web searches and Twitter posts – two forms of advertising governed by strict character limits – is the one that’s taking the most heat. In its guidance, the FDA asked that pharma companies strike a balance in these posts/ads regarding the benefits and risks of their drugs.
Specifically, in regard to Twitter, the FDA asked manufacturers to include the following in their 140-character tweets:
- The brand name of the drug
- The active ingredient
- The drug’s benefits and risks
- A link to more detailed information on the drug’s risks
And it’s important to keep in mind that most drug lawsuits are filed because a company failed to properly warn patients and doctors about a side effect in associated medical literature.
You can see why the agency wouldn’t want someone to believe, for instance, that a new diabetes drug could help manage symptoms without having any side effects. It makes sense – if a drug is promoted in a magazine or television commercial, there will undoubtedly be that fine print detailing the drugs’ side effects or an announcer forcing a laundry list of risks into the last three seconds of the commercial. So wouldn’t these companies want to err on the side of caution with regard to disclosing drugs’ risks on social media? Or is what the FDA’s asking impossible?
Big Pharma is arguing that the FDA’s proposed restrictions violate the First Amendment and even contradicts the way the FDA conducts itself on social media. Pharmaceutical Research and Manufacturers of America, for instance, pointed to a tweet sent by the FDA reading:
The trade group noted that this tweet did not include information about the drug’s risks, including the details of its black-boxed warning. The group claims the tweet contradicts the FDA’s proposed example, which reads:
“NoFocus (rememberine HCI) for mild to moderate memory loss-may cause seizures in patients with a seizure disorder www.nofocus.com/risk”
It’s understandable. The FDA’s examples of what a tweet should be probably aren't going to send sales skyrocketing. But, with social media platforms delivering information faster than ever, and if younger generations are more likely to see Twitter and Google ads as opposed to traditional ads on TV or in magazines, does that mean character limits should prevent them from knowing the side effects of the drugs they’re taking?
A Bigger Problem?
Let’s face it. Pharmaceutical companies make drugs that relieve symptoms, fight disease and prevent illness. But, we’re also living in a world where pharmaceutical employees are blowing the whistle on companies that promote drugs for unapproved uses or offer full-paid vacations to doctors that promote their products, while drug makers are destroying documents vital to pending litigation because they’d rather face court fines than have that information made public.
It may seem strange to think about, but the United States and New Zealand are the only countries that allow direct-to-consumer (DTC) pharmaceutical advertising. Travel to any other country and you’re not bombarded with ads during the six o’clock news telling you to ask your doctor about how drug Z can relieve symptoms X and Y.
A journal article titled “Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic” perfectly points out:
“The average American TV viewer watches as many as nine drug ads a day, totaling 16 hours per year, which far exceeds the amount of time the average individual spends with a primary care physician.”
And the drug companies know how effective DTC pharma advertising can be – every dollar spent increases sales by an estimated $2.20 to $4.20.
So is what the FDA’s asking a little extreme? It’s easy to see the companies’ gripes, but what happened to the time when your doctor would prescribe you a drug because he or she felt you needed it – not because you asked for it?
What do you think? Are Big Pharma’s tweets protected by the First Amendment? Do you remember a time when drug ads weren’t on TV? Share in the comments below!