Sicko Regulations

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This piece first appeared on July 25, 2007 on

In his new documentary Sicko, which calls for nationalized health care, Michael Moore shows a montage of ads urging the viewer to "ask your doctor" about various medications, implying the ads are responsible for over-medicating society. Lucky for patients, not everyone in Congress agrees with him. At least not yet.

Congressional leaders say they want to make drugs safer for the American consumer by limiting direct-to-consumer (DTC) advertising of newer drugs. But the measure under debate in the House will interfere with getting out information vital to consumers, and further impede the ability of the FDA to approve beneficial drugs.

Regulation, Then Legislaton

Last month the Senate, after intense debate, passed their version of a new Food and Drug Administration (FDA) bill that contained several important changes aimed at dealing with drug safety issues. In the process, an onerous requirement to pre-review all DTC drug ads for the first two years after marketing approval was deleted, allowing near-unanimous passage.

This month, the House Health Subcommittee will debate their version. All the leading congressmen supporting the proposed bill are Democrats, and all are vigorous supporters of stringent "safety" restrictions on pharmaceutical marketing. For example, the House bill calls not for a two-year but a three-year "cooling off" period, during which time the FDA will require pre-screening of DTC ads for new drugs. It also calls for mandated warning labels and detailed post-marketing monitoring for all new drugs.

Restricting Speech Without Enhancing Safety

Will such restrictions make our drugs safer? Not likely. In any case, the proposed measures are almost surely a violation of the protections of commercial speech emanating from the First Amendment. If these bans are upheld, what next? What about automobile ads? Auto accidents kill approximately 40,000 Americans annually. Why not limit or ban car ads on TV -- at least for those cars that are not among the "top 10" safest (but according to whom?). And what about cigarette ads? While the format and reach of cigarette ads has been limited since the Master Settlement of 1998 and cigarette ads were voluntarily withdrawn from TV in 1970 (in an arrangement that prevented potent counter-ads from having their effect), cigarette makers still find ways to get their sales pitch out, even to vulnerable teens -- with less supervision than the proposed House bill imposes on drug-makers.

The restrictions would do nothing to enhance drug safety but rather would interfere with consumer education on drug indications and side effects. Patients would remain unaware of remedies -- and in some cases even remain unaware that they were showing symptoms -- of treatable diseases. Surveys have shown consistently and clearly that the public benefits from these ads.

What happened to the doctor-patient relationship? Those behind the measure must assume that each time viewers see a DTC ad, they rush to get prescriptions from their doctors, who, sheeplike, comply with the request. This is not how the real world works. Doctors and patients need to discuss the risks and benefits of prescribed drugs, and the protections offered by physician prescription and FDA approval are substantial, even though no drug is guaranteed to be completely safe for everyone.

All drugs have possible side effects, ones not entirely predictable when the drugs are being taken by hundreds of thousands of people. Public and private insurance databases should be mined for signals of unexpected toxicity, as called for in the Senate bill and agreed to by the pharmaceutical companies. Big fines for misleading ads are also appropriate, as is the case with other ads monitored by the Federal Trade Commission. But banning DTC ads would help no one.

See also: ACSH's report and brochure on the benefits and risks of medications.