The FDA / DDMAC Request that Pfizer Discontinue use of an Ad for Geodon for Injection
I have reviewed materials available to me concerning the recent request by the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) that Pfizer discontinue its use of an ad placed in a professional journal for Geodon (ziprasidone mesylate) for injection. These materials included a copy of the ad, a facsimile of the letter from the DDMAC to Pfizer presenting it concerns, an article in World News - Reuters discussing the DDMAC request in which Pfizer spokesperson Ray Kerins is reported to have said the company will comply with the agency's request, as well as articles concerning the matter appearing on the Reuters website (http://www.reuters.com/), CNNMoney.com (http://www.cnnmoney.com/), and TMCnet News (http://www.tmcnet.com/).
Regulating and monitoring the materials used by drug companies to advertise drugs already on the market is an important function of FDA/DDMAC. The regulations concerning these matters are relatively clear and specific, although sometimes there is room for interpretation. These guidelines are necessarily highly technical and sophisticated, but then so are the participants in this on-going process.
While I do not pretend to understand the intricacies of the process or the merits of this case, the recent development concerning the ad for Geodon for Injection is illustrative. When the FDA, DDMAC, and pharmaceutical companies work cooperatively, as is apparently the case in this instance, the public health and safety is well served.
All this aside, this episode raises the thorny question of where do psychiartrists actually obtain the information about the prossible risks of use and side affects of the medications they prescribe. There are several possibilities, including, but not limited to: reading a medication's package insert; reading the write up concerning the medication in PDR; conversations with the drug company's salespersons; the ads placed by drug companies in professional journals; discussions with peers that have experience with the drug in question. There are so many drugs on the market today that the task of staying abreast of all this information for each and every medication is a daunting task, but, nonetheless, a significant responsibility of the psychiatrist.
There also remains a tangental question concerning whether or not all this information should be shared with patients. Although information about risks and side affects may induce some patients "to develop many of these possible difficulties," it is clear, at least in my mind, that if a patient is functional, all this information should be shared before that patient uses the drug.