FDA Guidelines Would Practically Ban Pharmaceutical Tweets

I can’t imagine what kind of people follow
pharmaceutical companies on Twitter, but apparently some do. Seeing
as following folks on Twitter is completely voluntary, I assume
those who do find their tweets informative, interesting, or useful
in some way. But
tweeting about pharmaceuticals will be effectively banned if
new Food and Drug Administration (FDA) guidelines are adopted.
Under
draft guidelines proposed Tuesday, any pro-prescription drug
tweet from a drug company would also have to list risks and side
effects.

Because Twitter is a medium built on non-voluntary brevity, the
new rule would make legally tweeting about prescription drugs
nearly impossible. According to the FDA, risk information includes
“all risk concepts from a boxed warning, all risks that are known
to be fatal or life-threatening, and all contraindications from the
approved product labeling,” in addition to a hyperlink to more
detailed information.

There are potential workarounds—attaching an image with a
drug’s complete warnings label to all tweets, using a tweet
extension app like TwitLonger—but whether these would suffice for
the FDA is anyone’s guess. The draft guidelines would also require
drug companies to include a product’s exact indication (“mild to
moderate memory loss” as opposed to just “memory loss” was the
FDA’s example).

“If a firm concludes that adequate benefit and risk information,
as well as other required information, cannot all be communicated
within the same character-space-limited communication, then the
firm should reconsider using that platform for the intended
promotional message,” the agency says.

The whole matter (like so many the FDA tackles)
seems to involve searching for a problem that doesn’t exist. There
are already ample ways a person can find out about a drug’s risks
and side effects; and because these
are prescription drugs, it’s not as if a person can run
out and buy them based on one Tweet. At some point, a doctor,
pharmacist, and boatload of pharmaceutical literature will confront
patients before they get their hands on it, providing ample
opportunity for discussions about, recitations of, and printed
warnings listing risks and side effects. 

Thomas Sullivan, editor of the Policy and Medicine blog
for medical education company Rockpointe,
said it wasn’t clear whether abbreviations or shortened
words would be allowed. 

“The FDA isn’t necessarily up on the realities of social media,”
Sullivan said, adding that the agency has offered to allow
companies to submit their tweets for approval beforehand.

Sullivan said that Facebook, which has no character limitations,
might still be useful for drug sellers looking for some traction on
social media. So far the agency has refrained from suggesting
regulations for image sharing sites like Pinterest and Instagram,
Sullivan said.

I’m sure it’s only a matter of time, the way things are
going.

But should we automatically dismiss the idea of regulating how
drug companies can advertise on social media? Twitter and Facebook
are, after all, advertising platforms in this context; and the FDA
governs how drug companies advertise in more traditional mediums.
Rightly or wrongly, the FDA currently has the authority to require
risk disclosures in printed or broadcast drug advertisements. But
it can’t compel a person, even a company spokesperson, to follow
all statements about X with Y and Z. So is a drug tweet more like a
television ad or an uttered statement? Does it matter? 

Advertisement or not, commercial speech is still afforded
protections by the First Amendment—even
commercial speech from drug companies. And I’m a fan of erring
on the side of free speech. If a drug company makes false
statements on Twitter, there are already existing legal correctives
for that. But that’s not what we’re facing. The FDA’s Twitter
guidelines seem to surpass what consumer protection warrants and
cross over into unconstitutional speech infringement.