Amidst the emotional appeals to end direct-to-consumer (DTC) advertising of prescription medicines, we should not lose sight of a few harsh realities.
Prescription medicine is one of the most highly regulated industries in the United States--as it should be. As part of this process, the marketing of those drugs is closely monitored and governed by a set of rules, regulations and practices that have evolved over the years, and that have been tested time and again in the courts.
DTC advertising is now a $4.5 billion communications category that brings valuable health product information to millions of Americans. The length of time it takes to get a drug through the FDA approval process and onto the market averages 8.5 years. Given that the health and safety of millions of people are at stake, that appears to be a reasonably safe period of time. Once the drug is approved by the FDA, drug manufacturers should remain free to market their products, but only subject to well-defined procedures.
One such practice--voluntary submission of commercials to the FDA before they are aired or published--insures that the ads pass FDA muster before going public. FDA statistics indicate that well over 90 percent of commercials are submitted by agencies and advertisers in advance, and receive prior approval before appearing in the media.
Now accepted as a customary prerequisite and industry orthodoxy, voluntary advance submission of drug ads effectively gives the government--not the advertiser--final control over the marketing messages that are communicated to American consumers. While this makes perfect pragmatic sense, the long-term legal effect of this practice is that advertisers of prescription drugs have surrendered their constitutional right to speech without advance government censorship--often referred to as prior restraint of speech.
In the hustle and bustle of writing ad copy, producing commercials, obtaining client approvals, and ultimately satisfying the FDA, advertisers probably give little thought to the constitutional implications of the last step in the process. But let's be clear: it is not insignificant.
Some would say this concession is a small price to pay for getting the product to market or keeping the regulators at bay. Others suggest that it is merely the cost of doing business. But we should not lose sight of the irony. If, somehow, Congress or the FDA were to legislate or regulate mandatory prior review of all drug advertising, it is likely the courts would strike it down. This would result in the status quo. The burden, once again, would fall to advertisers to find ways to communicate their products in a responsible manner. Voluntary advance submission, if nothing else, meets that burden
Hard-line critics calling for the abolition of prescription drug advertising tend to gloss over these realities. They pooh-pooh industry self-regulation as public relations puffery. And they rarely acknowledge the complexity and legal give-and-take inherent in the creative process that produces the commercials and print ads everybody criticizes.
We can stipulate that there is no perfect system that will achieve every public policy objective, and the current system has its flaws. In the aftermath of Vioxx both regulators and industry have been chastened on the matter of drug safety.
But Vioxx notwithstanding, disallowing the widespread communication about safe, FDA-approved drugs that stand to benefit millions of people is not prudent public policy.
In giving short shrift to current industry efforts and practices, those who call for the demise of DTC advertising have lost sight of the reality that medicines save lives, and information empowers people.
© 2005, Adonis Hoffman
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