Wednesday, May 20, 2009


Stop Doing it; Show Remedial Plan

In a detailed warning letter, DDMAC has demanded that J&J stop marketing Ultram through materials that minimize the drug's risks and overstate its efficacy. The warning letter can be found here:

Some of what is interesting about it is that the letter calls for evidence of a remedial plan as well as ceasing to use the materials. The relevant section reads:

"Because the violations described above are serious, we request, further,
that your submission include a comprehensive plan of action to disseminate truthful, nonmisleading, and complete corrective messages about the issues discussed in this letter to the
audience(s) that received the violative promotional materials."

It is a single example, but it is one of others in which companies are being required to send out materials to _correct_ problems with earlier marketing. It is also of a few that suggest that the days of deregulating DDMAC, which reached a peak during the Bush administration in which the number of such letters dropped by roughly 600%, has come to a close.

In connection with earlier threads, it also suggests the different kind of FDA which is under construction.


  1. I agree, Justice. The days of deregulation are coming a close.

    On May 18, 2009, Carolyn Clifford of WXYZ TV reported direct-to consumer ads have many drawbacks, one being, they can be risky.

    Since 1997, when restrictions on pharma ads were loosened, the industry has spent billions of dollars promoting their products directly to consumers, many of whom are asking their doctors for these meds.

    In fact, a recent survey from Consumer Reports revealed, “20 percent of those regularly taking a prescription medication have requested a drug they had seen or heard advertised. And the majority—67 percent—says their doctor did prescribe it. Another problem is the newest drugs being advertised might not be the safest.”

    Vioxx is a good example. In 2000, Merck spent $160M promoting the painkiller, and they kept on promoting it, even after there were links to heart disease, even though there were deaths, even though Merck knew of the dangers.

    For the full story see:

  2. I thought the numbers were actually higher re: DTC impact. One of the recent documents released related to the Seroquel cases refers to cranking up the "DTC machine"--full confidence that it worked.

    Anyway, there is a distinction (somewhere) between illicit DTC and any DTC.


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