Earlier this week, an anonymous Pfizer sales rep alleged on the Question Authority web site that she was forced to participate in efforts to promote a new AIDS drug to docs prior to FDA approval. And the HHS Office of Inspector General has supposedly been alerted.

The drug in question is maraviroc, which is the first in a new class of AIDS drugs. An FDA advisory committee last month recommended the agency approve the med and Wall Street believes annual sales will reach a few hundred million dollars. Maraviroc also represents an opportunity for Pfizer to expand its reach in the AIDS market.

Off-label marketing is a hot issue for drugmakers, of course, and particularly Pfizer, which is operating under a Corporate Integrity Agreement. And so in a memo this week, a Pfizer exec urged the HIV sales force not to discuss the new drug and reminded them of the legal problems that could arise if any violations occur.

This can be interpreted as a way for Pfizer to argue the correct messages are delivered to employees about such issues. Or some may see a belated effort to address a problem. That’s for someone else to judge. The allegations, however, remain to be proven.

In any event, the memo is duplicated below. It was not provided on Pfizer letterhead, but the source is reliable. When contacted this morning, the Pfizer vp said: “I’m not the appropriate person to discuss this with you.”

From: Mark Brown
Re: Maraviroc

I am certain that we are all encouraged by last week’s announcement that the FDA’s Antiviral Drugs Advisory Committee voted unanimously (12-0) to recommend the approval of Maraviroc for the treatment of antiretroviral experienced patients with CCR5 tropic HIV-1 infection. Of course, if approved by the FDA, Maraviroc would be the first member of a new class of oral HIV medicines in more than a decade.

We all recognize that the Advisory Committee action may generate a number of questions among practitioners who treat patients infected with HIV. For example, we appreciate that both the novel mechanism of action and the tropism assay will be unfamiliar to many of your healthcare professionals and may prompt inquiries.

Recognizing that you may receive a number of questions, we wanted to take this opportunity to remind you of two critically important points:

First, because Maraviroc has not been approved by the FDA, you must not engage in any form of pre-approval promotion. So, for example, Pfizer issued a press release to the media on April 24th following the Advisory Committee Hearing. You must not distribute or raise that press release or other media material with your customers.

Second, you may receive unsolicited questions about Maraviroc, tropism or the CCR5 class from your customers. In that event, you must advise the questioner that you are not able to respond to the question in light of the pending regulatory application.

Instead, you are to refer the customer to Global Medical Information at 1-800-438-1985. Global Medical Information is in the best position to respond to the inquiry.

The consequences of pre-approval promotion can be significant, and can go beyond disciplinary action for violation of a Company Policy. The FDA has not approved the Maraviroc label. Nor has the FDA finalized its views on an appropriate risk management plan for Maraviroc. Any promotional conduct at this point in time could adversely influence the FDA’s views on either the label or the Risk Plan, could prompt the FDA to send Pfizer a Regulatory letter or could lead to other legal action.

If you have any questions, please contact either your management team or me at 212-733-8911.
Thank you for your attention to this very important matter.

Mark Brown
Vice President, Sales
Pfizer Anti-Infective and HIV/AIDS Divisions
212-733-8911

Further reading…
Question Authority[tags]HIV, Maraviroc, Off-Label Marketing, Pfizer[/tags]