NEW YORK: The Coalition for Healthcare Communication has released a position paper proposing new FDA guidelines for the dissemination of ’off-label’ information.
NEW YORK: The Coalition for Healthcare Communication has released a
position paper proposing new FDA guidelines for the dissemination of
’Off-label’ refers to drug uses (known as ’indications’) that are not
approved by the Food and Drug Administration.
If adopted, the coalition’s proposals will have a powerful impact on
pharmaceutical PR. ’We wanted to try to introduce some law and order in
the marketplace, so as to not give the FDA more ammunition in court,’
said Jack Angel, executive director of the coalition. ’We don’t want
them to be able to say, ’See what happens when you let companies push
unapproved uses for their products?’ ’
The group’s proposal follows a recent US District Court ruling which
held that existing FDA guidelines for promoting pharmaceuticals and
related provisions of the FDA Modernization Act (FDAMA) were
In a memorandum, US District Judge Royce C. Lamberth wrote, ’The
government, however benign its motivations, simply cannot justify a
restriction of truthful, non-misleading speech on the paternalistic
assumption that such restriction is necessary to protect the listener
from ignorantly or inadvertently misusing the information.’ The FDA has
appealed the decision.
Doctors are already allowed to prescribe pharmaceuticals for any use
they want, regardless of the indication for which it was originally
The district court ruling would allow manufacturers to more aggressively
encourage off-label uses of their products.
While this means more money for drug companies (not to mention for PR
agencies working with them), some experts argue it could also be more
risky for patients. Though some drug suppliers promoted off-label uses
before the ruling, Angel said they were ’doing this at some risk.’
According to Angel, the coalition’s guidelines interpret the court
ruling as allowing off-label promotion to physicians only - not
consumers. The guidelines call for the truthful dissemination of
information from peer-reviewed journal article reprints and textbooks.
The information must not be ’false or misleading,’ and it should
disclose ’the company’s interest in the drug and the relationship
between researcher, authors, publishers and companies.’
The coalition’s position also stipulates that promotional materials must
’state that the FDA has not approved the indication being
According to a statement issued by the coalition, this position is
supported by Washington Legal Foundation v. Henney, which held that
restrictions on the free flow of scientifically accurate information on
off-label use of approved drugs and medical devices contained in FDAMA
and FDA guidelines were unconstitutional. These restrictions severely
limited the dissemination of materials that contained discussion of
’By allowing free scientific exchange while providing responsible
protection for integrity of the material, we ultimately improve patient
care,’ said Angel.