Regulation: a risky business
The FDA's response--that it was still busy evaluating contributions to its public hearing on DTC last November--implied that agency noses had been put out of joint.
PhRMA's feathers appeared similarly ruffled, with the association being mystified at the petition--and no doubt smarting the foundations for its own industry guidelines on DTC, just three months into effect, are already being questioned.
You could argue that the Coalition is attempting, vigilante-style, to undermine the work of industry's designated regulators. And you could level the charge that its timing couldn't be worse, throwing a monkey-wrench into the works so soon after the FDA's public hearings on DTC and the release of PhRMA's guidelines.
The trouble is, whichever way you look at the proposals, they just make so much sense.
The Coalition charges that, bound by current policy, advertisers' inability to predict how regulators will react to certain creative executions has spawned a swathe of bland DTC ads that "over-warn and under-inform"--spots that are cluttered with more risk-related messages than any human being could possibly absorb in 30 or 60 seconds.
What the Coalition is essentially saying is: Consumer ads are supposed to be for consumers. Let's stop suffocating advertisers with an ill-defined regulatory framework, borrowed from the professional promotion field, and instead learn more about the way consumers absorb information so that we can make these ads more informative.
The solution, it says, is to simplify the message and re-establish distinctions between the consumer and the healthcare professional. Instead of reeling off a slew of potential risks, the Coalition proposes that very DTC ad should simply remind consumers of the following:
That all drugs have potential risks as well as benefits. That prescription drugs can only be prescribed by physicians. That the decision to take a drug should involve a discussion of risks with the physician. And that patients should fully discuss their conditions, medical histories and medications with their doctors.
That's it. And if every DTC ad carried the same message, the Coalition claims, it would lead to better prescribing decisions and enhance doctor/patient discussions. It's hard to argue with that logic.
In fact, how did we reach the point where we now assume that, for the public to remain safe, each DTC ad must state every potential risk of the drug it promotes?
Surely it's more important that consumers are aware that the product being advertised is a prescription drug, and therefore intrinsically there will be some potential risks associated with it. And that they should discuss what those risks might mean for them with the only person qualified to give them that drug--their physician. Isn't that safer than throwing 20 pieces of information into the living room and expecting the befuddled viewer to figure it out?
However inconvenient or subversive the Coalition's proposal may seem, they deserve the consideration of the industry's policymakers. In the past year or so, the FDA, PhRMA and the industry have made considerable contributions to advancing DTC. But the debate is far from finished, and we shouldn't be closing the door to fresh logic that could make the medium work even better for advertisers, physicians and patients.