Soon most HIV-positive readers likely will be seeing the latest
issue of Poz magazine in their mail (even though they didn't
subscribe). In the latest, and perhaps last issue of Poz, the
editors went out of their way, devoting six full pages to
defending their HIV drug ads. While I hear the article is
pretty laughable, some still may be interested to know why the
FDA decided to crack down on the advertisements in the first
place. So we are printing the entire FDA letter that was sent
out last month to some eight drug companies that advertise HIV
drugs. Read it for yourself and we think you will agree with
FDA's Dr. Thomas Abrams's directive:
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20851
Dear Drug Company:
The Division of Drug Marketing, Advertising, and Communications
(DDMAC), through routine surveillance and monitoring, has
become aware that many direct-to-consumer (DTC) promotional
materials and activities for prescription drugs used in the
treatment of human immunodeficiency virus (HIV) infection do
not include important limitations associated with HIV
therapies. A recent review of some of these DTC promotional
materials and activities indicates that many do not adequately
convey that these drugs neither cure HIV infection nor reduce
its transmission. Additionally, the DTC materials and
activities may not clearly reinforce that the HIV drug being
promoted, with the possible exception of Trizivir, should be
taken only in combination with other drugs for HIV infection.
Although today's treatment regimens have transformed HIV
infection to a chronic disease in many patients, HIV infection
is still associated with significant morbidity and mortality.
Since HIV transmission may still occur on antiretroviral (ARV)
therapy, precautions must be taken to avoid spreading
infection. Furthermore, in most cases, combinations of drugs
are required to slow the progression of HIV Infection.
Therefore, DTC promotional materials and activities for HIV
drugs that do not prominently convey that HIV drugs do not cure
HIV infection, do not reduce the transmission of HIV infection
and must be taken in combination regimens are misleading
because they overstate the efficacy of these HIV drugs.
DDMAC has also noted that some DTC materials and activities for
HIV drugs utilize images that are not representative of
patients with HIV infection.
Examples of such images range from robust individuals engaged
in strenuous physical activity to healthy-looking individuals
giving testimonials of a specific drug's benefit. However, not
all individuals have a response to ARV therapy; in fact, some
patients will still have disease progression despite ARV
therapy. Furthermore, some images minimize the significant side
effects profile associated with HIV drugs, including metabolic
changes such as fat redistribution or facial wasting.
Therefore, images that are not generally representative of
patients with HIV infection are misleading because they imply
greater efficacy than demonstrated by substantial evidence or
minimize the risks associated with HIV drugs.
DDMAC has not previously objected to DTC promotional materials
and activities lacking important limitations associated with
HIV drugs or using images not generally representative of
patients with HIV infection.
However, we are hereby informing application holders that may
be promoting their HIV drugs to consumers without prominently
displaying the limitations listed above or using images not
generally representative of patients with HIV infection that
such promotion is in violation of the Federal food Drug and
Cosmetic Act and its applicable regulations. Because these
comments constitute a change in our position, sponsors will be
provided a reasonable period of time to make necessary
revisions to their promotional materials. Accordingly, all
revisions should be completed within 90 days of receipt of this
letter or at the next printing of new material, whichever comes
first. Please notify DDMAC in writing by May 18, 2001 of the
specified promotional materials that will be revised and the
date the revisions will be implemented.
If you have any further questions or comments, please direct
them to Rebecca Redman, Pharm.D., by facsimile at (301)
594-6771 or by written communication at the Division of Drug
Marketing, Advertising, and Communications, HFD-42, Room
17B-20, 5600 Fishers Lane, Rockville, MD 20857. We remind you
that only written communications are considered official. In
all future correspondence regarding this matter, please refer
to [FDA deleted word(s)] and the NDA number.
Thomas Abrams, R.Ph., M.B.A.
Division of Drug Marketing, Advertising, and Communications