You see it every time you turn on the TV. The prompt to "talk to
your doctor," paired with rushed, small-print, side-effects
disclosure, hastily run across the screen. There is a chance that
this may change. On Nov. 17, 2015, the American Medical Association
(AMA) called for a ban on direct to consumer advertising of
prescription drugs and medical devices.
The cost of health care is a huge issue in America right now.
Pharmaceutical companies have placed themselves in the very center
of the debate with their pricing practices. For example, Valeant
Pharmaceuticals acquired two old heart drugs in February 2015 and
promptly increased their prices by more than 500 and 200 percent.
Consumers became upset, Congress took note, and President Barack
Obama held a public forum on the rising cost of prescription drugs
on Nov. 20, 2015. According to an October 2015 Kaiser Family
Foundation poll, prescription drug affordability is the number-one
consumer health care concern, so the forum was likely
Where does the legal community come into this? United States
Attorney's offices in Manhattan and Massachusetts have already
issued subpoenas relating to the pricing, distribution, and patient
support practices of Valeant. Drug companies often receive
subpoenas, but while many of these do not result in charges or
settlements, the fear of an investigation is often enough to drive
One recent attempt to regulate pharmaceutical companies regards
the promotion of drugs to physicians. The Food and Drug
Administration (FDA) brought suit under misbranding charges under
the Food, Drug and Cosmetic Act in United States v.
Caronia. Decided on Dec. 3, 2012, this was the first time a
federal district court directly addressed the connection between
the First Amendment protection of speech and pharmaceutical company
promotion of FDA-approved drugs for non-FDA approved uses (also
known as "off-label").
On Aug. 7, 2015, in Amarin Pharma, Inc. v. FDA, the
United States District Court for the South District of New York
interpreted Caronia broadly to protect any truthful,
non-misleading speech to physicians about legal (although
off-label) use. One of the FDA's concerns with Amarin's proposed
disclosure to physicians was that the disclosure would cause a
physician to prescribe Vascepa in lieu of promoting healthy dietary
and lifestyle changes or prescribing statin therapy. The court
dismissed this concern, claiming that physicians are able to
understand nuanced drug distinctions and clinical results.
Finally, the Amarin court affirmed that the FDA can
pursue mislabeling charges under the FDCA against pharmaceutical
companies promoting speech that is not truthful or non-misleading.
Because "truthful" and "non-misleading" are vague and subjective
terms that change as new science and medicine develops,
pharmaceutical companies will likely keep the FDA involved in the
creation and promotion of marketing materials and labeling
regardless. Thus, like for subpoenas, the fear of action (here a
misbranding suit) may be enough to drive compliance despite these
two pro-pharmaceutical company rulings.
Another recent attempt to regulate pharmaceutical company
promotional speech regards the advertising of drugs to consumers.
The AMA has called for a total ban on prescription drug and medical
device advertisement. Apparently, the cost of generic and
prescription drugs has increased consistently (4.7 percent this
year), and New Zealand is the only other country in the world that
allows advertising of prescription drugs directly to consumers. The
AMA believes that the large amount of money spent on ads
contributes to this increase in drug prices.
The AMA is also concerned that such advertising causes customer
confusion and creates high-demand for expensive treatments. If
prescriptions are too costly, patients will delay treatment,
creating a real risk to the health of the public. The AMA's
concerns with pharmaceutical advertisement targeted to consumers
mirrors one of the FDA's concerns in Amarin with proposed
disclosures to physicians. However, the Amarin court's
assurance that physicians can adequately interpret the disclosure
message does not apply in the area of consumer advertising. It will
be interesting to see how this plays out, especially given the
limits Amarin has set on the FDA's ability to regulate