For an agency that has complete veto power over the release of drugs and devices, the Food & Drug Administration must find regulating the promotion of such products rather frustrating. Thanks to that pesky First Amendment, it can’t simply ban advertising for or prohibit all discussion about those products. But it can, and rather vigorously does, enforce vague rules on what marketers can say about their products. FDA does this through random warning letters which offer no binding guidance to regulated entities.
FDA’s disdain for drug promotion, and its desire to ensnare more companies and thus chill more speech, are both apparent in a new program its marketing regulation division, DDMAC, announced on May 11 called the “Bad Ad Program.” The program urges doctors and other care providers to discover “misleading prescription drug promotion” and report it to FDA. The agency will target doctors at medical conventions and work with medical societies to swell the ranks of informants.
The very existence of this program could do more to chill the open exchange of health information than any FDA regulation or warning letter. Some doctors who find sales rep visits to be unbearable or chafe at consumer advertising might see this, as one commentator put it, as “a chance to get even.” Free and open exchange of information at conventions and other meetings may become a thing of the past if drug and device makers are constantly wondering which physician has FDA on speed dial. Whether FDA likes it or not, product makers have integral knowledge of their drugs, and when such information isn’t shared with doctors, patients lose out.
How is American health care improved when physicians are distracted by the lure of government whistleblowing? As Eye on FDA so appropriately noted:
I’m not sure I want my doctor hunting down bad ads. I want my doctor to spend that time moving to electronic medical records (he still uses hand written) or engaging me online (he doesn’t), or taking my call (he does call me back). Does my doctor have time to hunt down bad ads? Frankly, on a cost/benefit ratio, for me the patient, I see the benefit as marginal, while anything taking up my doctor’s time that isn’t directly related to the quality of health care I get from him is of almost no benefit to me.