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The FDA letter to HIV drug makers


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:


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


Copyright © 2001 -Bay Area Reporter, Publisher. All rights reserved to Bay Area Reporter. Reproduction of this article (other than one copy for personal reference) must be cleared through the Bay Area Reporter.

Information in this article was accurate in July 6, 2001. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.