Mike the Mad Biologist

The American Medical Association has called for a temporary ban on all direct-to-consumer advertising for prescription drugs. Sounds 'elitist'? Well, so are professional sports. But only an idiot would trust Madison Avenue over his or her doctor. (an aside: I'm not an MD. I just have the occassional good sense to listen to people who know what they are talking about).

From ScripNews (subscription only):

The American Medical Association is calling for a temporary ban on direct-to-consumer advertising for newly approved prescription drugs, with the length of the ban to be determined on a case-by-case basis.

An advertising moratorium is needed to give doctors time to be appropriately educated about a new drug, the physicians group said. The AMA's house of delegates adopted the position on DTC ads during its annual meeting in Chicago, Illinois.

The duration of the advertising moratorium should be determined by the US FDA in its negotiations with a drug's sponsor at the time of approval, the AMA said. The length of the moratorium may vary from drug to drug depending on various factors, such as the innovative nature of the drug; the severity of the disease that the drug is intended to treat; the availability of alternative therapies; and the intensity and timeliness of the education about the drug for physicians who are most likely to prescribe it.

The AMA delegates adopted additional guidelines on the content and placement of DTC ads, including FDA review and pre-approval of ads before they run. The ads should also:

. provide objective information about drug benefits that reflect the true efficacy of a product, as determined by clinical trials;
. show fair balance between benefits and risks by providing comparable time or space and cognitive accessibility, and presenting warnings, precautions and potential adverse reactions in a clear and understandable way without distracting content;
. clearly indicate that the ad is for a prescription drug and refer patients to their physicians for more information and treatment; and
. be targeted at age-appropriate audiences.

Product-specific DTC ads generally should not use an actor to portray a healthcare professional who promotes the drug because this may be misleading and deceptive, the AMA said. If actors are used to do this, a disclaimer should be prominently displayed.

Last year, the AMA's house of delegates considered a number of resolutions relating to DTC ads but deferred action pending further study of the issues. The proposals included recommending a ban on all DTC ads and urging the FDA to require inclusion of comparative quality data in ads.

In the meantime, the US industry trade group PhRMA announced new guiding principles for DTC ads last summer. The principles took effect on January 1st and generally recommended that all DTC ads should be accurate and not misleading, and should make claims only when supported by substantial evidence. Ads should reflect a balance between risks and benefits and should be consistent with FDA approved labelling, the PhRMA guidelines stated.

The industry principles called for manufacturers to educate physicians about a new drug before launching a DTC campaign, although the guidelines did not set a specific time interval for this. Television ads should be targeted for audience and age appropriateness, and all ads should be submitted to the FDA before being aired or printed.

PhRMA said that the delay in launching ads for a new drug pending physician education should take into account factors such as the complexity of the product's risk/benefit profile and healthcare professionals' prior knowledge of the condition being treated. "The length of time this requires will vary from medicine to medicine, and companies will likely meet this goal in different ways," the industry group said.

"While there are subtle differences between the guiding principles and the AMA's report, both emphasise the critical need to educate physicians and other healthcare providers about a new medicine before it is advertised to the public," PhRMA said.

The AMA's board of trustees noted that most PhRMA member companies have agreed to abide by the voluntary guidelines, and some individual companies have announced specific initiatives, such as a time-specific moratorium, that go beyond the industry principles.

The physicians group also called for additional research on the effect of DTC advertising, including the impact on the patient-physician relationship, overall health outcomes and cost-benefit analyses.