Exploring Human Potential

The Future of Physician Prescribing: Part III – The “Learned intermediary” and DTC Advertising


Mike Magee

After the passage of the Durham-Humphrey Amendment, defining the difference between prescription and OTC drugs, and requiring labels on the prescription drug package saying “Caution: Federal law prohibits dispensing without a prescription.”, the physician’s prescription became standard practice. Both the government and the pharmaceutical industry saw the utility in this arrangement.

In 1962, in the wake of the Thalidomide disaster, the Kefauver-Harris Drug Amendments passed. For the first time, the FDA required manufacturers to prove effectiveness (efficacy) as well as safety before marketing a drug. The granting of approval of a drug and its’ label by the FDA not only provided approval for sale and distribution, but also conveyed a defense and partial protection from liability should the drug harm a patient through a side-effect listed on the label.

Responsibility and liability was further clarified in 1966 by The United States Court of Appeals for the Eight Circuit in the case Sterling Drug v. Cornish. Coined the “learned intermediary rule”, it established that the duty of the manufacturer to communicate the risks and benefits of their pharmaceutical products need not be communicated directly to patients. Rather, this obligation was better fulfilled by communicating these complex facts to physicians, and leaving it to the physician “learned intermediary” to individualize these facts and communicate them face-to-face with the patient.

With this law, there was now a clear delineation of responsibilities, a reliance on physician as “expert”, a tracking system embodied in the legal prescription, and a transfer of responsibility and liability from industry to doctor to patient. In return for bearing this responsibility, the physician gained near exclusive control over access to an increasing range of marvelous discoveries that might save your life. If you wanted one of these discoveries, you had to go see your doctor.

In 1985, under enormous pressure from the Reagan Administration, industry and its’ allies, the FDA partially lifted its ban on direct-to-consumer” advertising (DTC). Initially the ads were general and “informative”, and the design made advertising costly and ineffective for anything but print ads. By 1990, the first product specific ad, for Rogaine for hair loss, appeared. In 1998, liberalization of the rules for follow-up detailed information, made television ads feasible. From there on, pharmaceutical manufacturers became top advertisers on TV.

It didn’t take long for legal scholars to point out that DTC advertising seriously undermined tort law’s “learned intermediary” arguments. A Cornell Law scholar in 1993 stated, “Direct-to-consumer advertising undermines the traditional legal rules governing transmission of information to patients… When drug manufacturers advertise directly to consumers, they bypass the intermediary assumed by the traditional legal duties. The drug company has no duty under current regulations to provide a warning tailored to the consumer. The required physician-directed warnings are too complex to efficiently educate consumers. Further, the doctor must deal with an unknown source of information. The doctor will find it commensurately harder to educate patients with preconceived expectations about a treatment gained from direct-to-consumer advertisements.”

The recent cases of documented over-prescribing and fraud in the cases of Oxycontin and its’ resultant opioid epidemic, and Adderall and its’ competitors in the creation and popularization of ADHD with the active cooperation of numerous publicly funded school districts, also challenges the tort law decisions on “learned intermediary”. In these cases and others, active collusion between the respective manufacturers and “thought leader” physicians has been thoroughly substantiated.

Physician prescriptive powers now finds itself trapped in “no-man’s land” between a Medical-Industrial Complex that financially rewards cooperation, collaboration, and at times collusion, and the traditional role of “learned intermediary” that has anchored the profession’s claim to the extraordinary privilege of prescribing access to drugs. What questions will the profession be called upon to answer in the future?

Do the thousands of physicians who sloppily prescribed Oxycontin and Adderall deserve to be titled “learned intermediaries”?

Who is holding them accountable?

If they are not fully competent, should other health professions be allowed into the exclusive “prescriber club”?

Why are we continuing to complicate lines of responsibility by allowing DTC advertising when all but one other country in the world outlaw it?

And who is measuring the quality of the prescriptions being written in real time?


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