Dan Jaffe from the Association of National Advertisers participates in a Q&A regarding the AMA’s recent call for a ban on direct-to-consumer advertising of drugs.
On November 17th, the American Medical Association (AMA) adopted a new policy with the intention of making prescription drugs more affordable. Every year, according to a press release on the matter, billions of dollars are spent advertising and promoting prescription products. As a result, the AMA has called for a ban on direct-to-consumer (DTC) pharmaceutical advertising in the United States.
For more information, see our previous story: “AMA Calls for Ban on Prescription Drug Ads.”
The Association of National Advertisers (ANA) has called this ban “wrong and misguided,” in response to the vote last Tuesday.
Dan Jaffe, Group EVP, Government Relations from the ANA, voices his thoughts on the matter.
Q: Could you describe the history of DTC pharmaceutical advertising in the United States? When did this practice start? How has it evolved over time?
Jaffe: The first advertising for prescription drugs outside medical journals began in the 1980s in consumer magazines. The FDA then began modernizing restrictions and issuing guidance on DTC advertising in the mid-1990s. The FDA approved broadcast advertising for prescription drugs in 1996. It was done through a guidance adopted by the agency that imposed restrictions on how the ads must follow the approved content of drug labeling and that advertising must provide contraindication information. The FDA’s guidance continues to evolve. The FDA has fine-tuned its guidance over the years, specifically concerning the “brief statement” in print ads and the “major statement” dealing with side effects and contraindications in television ads.
Q: What are some of the common practices in DTC pharmaceutical advertising?
Jaffe: For print advertising, the so-called brief statement includes a very detailed list of benefits and risk information. For broadcast media, the disclosures are more abbreviated, covering the principle contraindications.
Q: What is the average expenditure involved with DTC pharmaceutical advertising?
Jaffe: It has been reported that that the pharmaceutical industry spent $4.5 billion on DTC ads in 2014. It is predicted that the pharmaceutical industry will spend in that range again this year.
Q: What, would you say, are some of the reasons that led the AMA to call for a ban on prescription drug advertisements?
Jaffe: Historically, when the AMA has considered taking a position against DTC advertising, they state that the advertising is misleading and does not give a professionally-accurate picture of the benefits and contraindications of a drug. However, the FDA strictly requires that advertising must follow the FDA-approved labeling that states the risks and the benefits. If the advertising is misleading, the FDA has a tough set of rules that it may use to sanction false advertising. Also, some doctors want to be the sole purveyors of prescription drug information. Finally, some in the AMA claim that DTC advertising is leading to higher prescription drug costs. As we note below, we do not think that such a claim is accurate.
Q: Do you think a ban on DTC pharmaceutical advertising would help to curb pharmaceutical costs?
Jaffe: We do not believe prescription drug advertising is a driver of increased drug or medical costs in the U.S. Prescription drug advertising facilitates competition in the marketplace that should help mitigate price increases. Also, by providing consumers information about new treatments for various potentially serious or life-threatening diseases, it helps to provide consumers with the ability to avoid major and costly harms that would impose substantial and avoidable societal costs.
Q: At present, the U.S. and New Zealand are the only nations that allow DTC pharmaceutical advertising. Could you describe some of the history behind this?
Jaffe: We cannot speak for other countries, but in the U.S., the First Amendment, as interpreted for the past forty years by the U.S. Supreme Court, specifically protects the right to advertise products so long as the advertising is truthful and not misleading. A number of Supreme Court cases have specifically upheld the First Amendment rights of DTC prescription drug advertising. The ban adopted by the AMA House of Delegates, if enacted by the congress, would almost certainly be struck down by a federal court.
Q: Since the AMA, at present, is calling for a ban on DTC pharmaceutical advertising—what’s next? If they were able to achieve this ban, how soon would that go into effect? How would it affect pharmaceutical companies in the U.S.?
Jaffe: To reiterate, proposals similar to the ban called for by the AMA likely will never be enacted by the congress. These types of restrictions and bans have been proposed in the past in both the U.S. Senate and House and have been soundly defeated. If Congress were to enact such a ban, it would not survive a First Amendment challenge.
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