The American Medical Association recently called for an FDA-mandated moratorium on direct-to-consumer (DTC) drug ads and left it up to the industry and FDA to work out the details; ie, how long the moratorium should be for each drug. Seems reasonable enough considering that some pharmaceutical companies (eg, Pfizer and Bristol Myers Squibb) already have voluntarily placed moratoriums on DTC ads for new drugs. BMS, for example, set the period at 1 year (see “Pfizer DTC Pledge: ED is Litmus Test“).

It’s interesting to see how the press and industry publications are reporting on this. Looking at the headlines, one finds a whole gamut of viewpoints ranging from “glass three quarters empty” to “glass three quarters full.” Here are a few examples (you can determine how full or empty the glass is in each case):

All are reporting on the same event. Here are excerpts from the AMA press release:

The American Medical Association (AMA) today announced new policy on direct-to-consumer (DTC) advertising of prescription drugs and implantable medical devices. The new policy includes imposing a temporary moratorium on the advertising of newly approved drugs and guidelines for pharmaceutical companies to follow when preparing DTC advertising.

In addition to the moratorium on newly approved drugs (the time interval for this moratorium will be determined by the Food and Drug Administration (FDA)), the AMA adopted additional guidelines for DTC ads, they:

  • should provide objective information about drug benefits that reflect the true efficacy of the drug, as determined by clinical trials;
  • should show fair balance between the benefits and risks of the advertised drugs by providing comparable time or space and cognitive accessibility, and by presenting warnings, precautions and potential adverse reactions in a clear and understandable way without distraction of content;
  • should clearly indicate that the ad is for a prescription drug and refer patients to their physician for more information and appropriate treatment; and
  • should be targeted for age-appropriate audiences; and
  • should receive pre-approval from the FDA

The AMA also calls for additional research into the effects of DTC advertising on the patient-physician relationship, overall health outcomes and health care costs.

John Kamp, staunch drug industry supporter and fighter for “truth, justice, and the American way,” quickly asserted that “Dr. Kildare is dead”:

“AMA’s vision of a DTC moratorium looks like government censorship, not patient empowerment, free speech or enlightened public policy,” said John Kamp, executive director of the Washington-based Coalition for Healthcare Communication (CHC). “Dr. Kildare is dead. Patients now expect the information that respects their partnership in vital medical decision-making.”

“Respecting [patient] partnership in vital medical decision-making” is a funny concept coming from a guy who also defends his organization’s opinion that “the patient is the decision-maker only with respect to whether a practitioner should be approached.” (See “DTC without the Risk“.)

On the one hand John Kamp champions the “vital medical decision-making” patient role and on the other hand CHC sharply limits patient decision making to “should I visit the doctor or not?” Which is it? I guess it all depends on what the definition of “is” or “it” is.

The latter view of the patient is the Dr. Kildarian perspective — ie, an old-fashioned American way of looking at the patient. That “American way” is about as relevant to America today as Ford or GM cars are to teenagers! duh!

Benefit vs. Risk — It’s About the Money
I am sure the CHC also doesn’t like a few other AMA proposals such as DTC ads “should show fair balance between the benefits and risks of the advertised drugs by providing comparable time or space and cognitive accessibility.” CHC petitioned the FDA to require even less risk information in DTC ads than there is currently (see “Communicating Risk: Let the Dialog Begin“).

The main problem with the AMA proposal on fair balance is “time” and “space,” both of which cost money for drug advertisers. And that’s what CHC is — a coalition of drug advertising agencies who have to include all the cost of ad “time” and “space” in their campaign budgets that their pharmaceutical clients pay for. With pharma taking a more critical look at their advertising budgets and where best to spend their money, I am sure the ad agencies are feeling the pinch and are looking for ways to reduce their ad campaign budgets — but without cutting back on their slice of the pie. So, rather than going to “economic war” with journals and TV networks, it is much easier for them to address the “time and space” problem by cutting back on communicating risk information.

At least that’s my take on it.

More blog posts about DTC advertising…click here.

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