State courts in West Virginia and New Jersey that declared the “learned intermediary” doctrine outmoded by DTC advertising were right on the money, according to Government Accountability Project executive director Mark Cohen.
Writing in an online column in November, he said the doctrine made some sense until the appearance of the first DTC ad in 1981 and FDA's 1997 advertising guidance.
Citing drug ad revenues that he said have gone from $12 million a decade ago to $4.1 billion in 2005, Cohen asserted that “drugmakers spend more money on DTC than they do marketing to physicians. Doctors report increasing numbers of patients requesting particular brand-name prescription products. And physicians fear that if they don't give the patients what they want, a competitor will. In today's world of managed care, patients are more likely to be herded through office visits and seen by virtual strangers than be attended in their home by kindly, life-long family confidants.”
He said that if other states follow the lead of New Jersey and West Virginia in eliminating the learned intermediary, drugmakers will be legally and financially accountable for fully informing patients about product risks.
Meanwhile, American Enterprise Institute resident fellow Ted Frank has weighed-in on the side of the embattled doctrine, writing that there are problems with the courts' opinions.
First, he wrote, making decisions about the optimal level of DTC advertising might seem a usurpation of prerogative, particularly in a case in which the defendant did not do any DTC ads.
Second, Frank said, many drugs are not advertised. “Why should the protections of the learned intermediary doctrine be removed from drugs that were (1) never advertised DTC or (2) advertised DTC, but the patient who brought the case never saw the ad?” he asks. The third problem, he said, is that it is impractical to warn patients directly about the risks associated with drugs; labeling is written for doctors. His fourth point: only doctors and product liability lawyers read package inserts from cover to cover.