Facing increased scrutiny of drug ads, companies announce voluntary measures.

After being warned about ads for Zyrtec, Pfizer is changing the way it promotes its drugs. Credit: US Food and Drug Administration

In an attempt to deflect Congressional regulation, the pharmaceutical industry has announced voluntary measures that would temper the tone of consumer-directed drug advertisements. The move comes amidst growing public distrust of the ads, and tighter regulatory scrutiny.

The US Food and Drug Administration (FDA) has recently doubled the number of warning letters it sends to pharmaceutical companies about false or misleading ads. The agency also announced in August that it intends to conduct a comprehensive review of its advertising regulations for the first time in a decade.

The guidelines, detailed 2 August by the Pharmaceutical Research and Manufacturers of America (PhRMA), ask the group's member companies to more accurately convey drug benefits and risks in their direct-to-consumer ads.

As long as there is no one out there cracking the whip on drug companies, you will have these dangerous, misleading ads. Sidney Wolfe, Public Citizen

Two companies also made independent decisions to rein in their drug ads. Bristol-Myers Squibb on 13 June announced that it would not launch consumer ads for one year after a medicine is introduced, allowing the company time to first educate physicians. Pfizer said on 11 August that it would improve its ads to better communicate risks and reinforce the doctor-patient relationship. It also promised to invest as much in a campaign addressing important public health issues as it typically spends on ads for a branded drug.

The industry is responding to a backlash against a flood of print and broadcast advertising prompted by a loosening of FDA regulations in 1997. Spending on ads grew from $965 million that year to $4.1 billion in 2004, according to IMS Health, a market research firm.

As the number of ads has grown, so has the public's distrust of them. According to a February poll by the Kaiser Family Foundation, 18% of respondents said they could trust ads “most of the time,” compared with 33% in 1997.

In an effort to improve the ads' public image, the PhRMA guidelines call on manufacturers to cease 'reminder' ads—which name drugs but not their uses or risks—and to target ads to appropriate audiences, for instance by not airing television ads for erectile dysfunction drugs until children are asleep. They also suggest that companies should educate doctors about new drugs before launching consumer ads.

Critics assailed these steps as inadequate and insisted that more government power is needed to regulate the ads. “As long as there is no one out there cracking the whip on drug companies, you will have these dangerous, misleading ads going out and people taking drugs that are more dangerous and less effective than they seem to be,” says Sidney Wolfe of Public Citizen, a liberal watchdog group.

Wolfe says the FDA should be given the power to impose large fines on companies that make false or misleading commercials, rather than the letters it now sends, demanding that they immediately pull offending ads. As of 31 July, the agency had sent 27 warning letters this year, up from 24 in all of 2004.

But Jack Calfee, a resident scholar at the conservative American Enterprise Institute in Washington, says the ads provide patients with important information that neither the government nor physicians are equipped to disseminate.

Republican Senator Charles Grassley, who chairs the Senate Finance Committee, has introduced legislation that would require ads for new drugs to be vetted by the FDA during the first two years they are on the market. By contrast, Grassley noted, the PhRMA guidelines provide “not a single guarantee for consumers.”