(l)(1) Advertisements subject to section 502(n) of the act include advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems.21 C.F.R. §202.1(l)(2) (emphasis added). Indeed, a lot of package inserts have patient-friently information (often called “medication guides”) attached directly to them in “tear off” form for distribution for patients if the physician so chooses. The FDA even compiles and makes this material available on its website.
(2) Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints and similar pieces of printed, audio, or visual matter descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by medical practitioners, pharmacists, or nurses, containing drug information supplied by the manufacturer, packer, or distributor of the drug and which are disseminated by or on behalf of its manufacturer, packer, or distributor are hereby determined to be labeling as defined in section 201(m) of the act.
We've seen a lot of discussion of reason #1, but not much of reason #2.
- The warning duty is owed to the physician because the physician is the only person with knowledge of both the particular patient’s medical history and condition (in Texas, the word used is “susceptibilities”) and the risk/benefit profile (called “complex” and “esoteric”) of the drug.
- Directing the warning duty to the physician keeps the common law in accordance with the restricted distribution system for prescription drugs/devices imposed by the federal Food, Drug & Cosmetic Act.
- Requiring prescription drug/device information to be routed through the doctor preserves the physician/patient relationship from outside interference.
- Lay patients would be unable to understand the medical terminology necessary to explain the risk/benefit profile of prescription drugs/devices.
- As a practical matter, it is difficult for drug/device companies to communicate directly with patients.
We’re not going to clutter up those bullet points with hordes of citations. We’ve discussed these policy reasons before, and Chapter 2 of Bexis’ book has a complete listing of the cases (there are lots) supporting each of them.
Physicians no longer make the final decision as to whether a patient will take a drug - patients make those decisions. . . . After years of patients being subjected to direct advertising, physicians state that they are increasingly asked and pressured by their patients to prescribe drugs that the patient has seen advertised. . . . Physicians argue it is not their fault; rather, they claim pushy patients, prodded by [direct-to-consumer] advertisements, pressed, wheedled, begged and berated them for quick treatments. Physicians claim that it is impossible to compete with pharmaceutical companies’ massive advertising budgets, and resign themselves to the fact that if consumers make enough noise, they will eventually relent to patient pressure.
Hamilton, 310 S.W.3d at 507 (various citations omitted).
Since the Hamilton plaintiff was not exposed to any DTC advertising before a prescription was written, Hamilton is pretty far from the situation the DTC exception purports to address. That's not accidental.