Washington Editor

WASHINGTON - As efforts to limit drug advertising reach a growing number of listeners, opponents to such restrictions also are making their voices heard, and those in the latter camp don't foresee any sweeping changes in the near term.

"It provides valuable information that can help save lives," said Adonis Hoffman, the senior vice president and counsel at the American Association of Advertising Agencies, emphasizing that direct-to-consumer (DTC) advertising heightens consumer awareness.

Speaking as part of a discussion hosted by the Washington Legal Foundation last month, he noted that a number of public opinion studies, some of which were conducted by the FDA, indicate that the practice is largely welcomed among consumers, and "millions more Americans are being treated for previously undiagnosed diseases since the FDA allowed DTC advertising in 1997."

Hoffman's conclusions were drawn partly from a pair of surveys - one conducted in 2002 by the FDA and another put together two years later by Prevention Magazine - which suggested that direct-to-consumer advertising prompted 23 million to 30 million Americans to talk to their doctors about a new or previously untreated condition.

Hoffman added that lawmakers on Capitol Hill and regulators at the FDA, who are considering restrictions on drug advertising, instead should be guided by such data that point to this consumer value, saying that "regulation light is probably the best order of the day."

In November, the FDA held a public hearing on direct-to-consumer drug advertising to consider potential limitations, though no new guidelines have come forth from the meeting.

One common proposal would allow the FDA to screen advertisements before a product receives approval, but Richard Samp, the Washington Legal Foundation's chief counsel, said it wouldn't gain traction because the agency would never waive its right to regulate ads after that pre-clearance and drug companies wouldn't move forward with the idea without such a concession.

A few bills being pondered by Congress these days also could curtail drug promotion, proposed measures spawned of late because of the growing belief that such advertising can be linked to product safety issues and rising drug costs. But opponents of such legislation, such as those at the Washington Legal Foundation, call such efforts unconstitutional and view them as infringements on free speech rights.

The organization is so wrapped up in the issue that it monitors and responds to every FDA letter that challenges drug makers' advertising practices, charging that the agency's Division of Drug Marketing, Advertising, and Communications (DDMAC) ignores First Amendment limits on its regulatory authority.

The Washington Legal Foundation also is fighting government regulators' use of the so-called "false claims act" to go after drug companies that allegedly are wrongly promoting the off-label use of their products.

That was the tactic used against Serono SA, which settled for $704 million in the face of charges that it illegally promoted the AIDS wasting drug Serostim [somatropin (rDNA origin) for injection].

In that case, the Geneva company's U.S. affiliate recently entered a guilty plea to formally conclude its settlement of the government investigation led by the U.S. Attorney's office in Massachusetts.

But Samp noted that "the claims are made, generally, by health care providers," not drug makers. Still, government regulators have succeeded in linking off-label promotion to reimbursement claims submitted by providers, suggesting that drug makers "are causing others to make false claims."

More than 100 such cases still are pending, he said, though they remain under seal so there is no way of knowing specifics about them. But Samp said most rarely go to court and instead are settled, as companies that lose a court case would not only deal with the monetary penalties incurred even in settlements, but also face the possibility of being excluded from participating in government programs, a potentially heavy price to pay for drug companies. "We think what's going on here is wrong," he said.

In addition, settlements often include corporate integrity agreements that allow the FDA to more closely monitor companies' marketing efforts and "police [them] in much greater detail," said David Bloch, a partner at Reed Smith LLP. He attributed such heavy oversight as a reaction to a growing public skepticism of drug companies.

Bloch told BioWorld Today that this kind of wariness is "obviously a big concern for the industry," and later added that drug companies should improve their communications to overcome such troubles. "They need to make the message clearer so the public understands how hard it is to make drugs," he said, "and how much it costs to make drugs."

Hoffman added that drug companies should work harder to dispel myths that are tied to their advertising practices, such as the belief that promotional spending drives drug costs.

He also said that naysayers should understand that advertising encourages greater patient compliance, and that the proper use of drugs keeps people healthy and working rather than in hospitals and nursing homes.

"In fact," he said, "increased drug spending often leads to reduced spending on other more invasive and expensive health care treatments."

In the end, he and his colleagues cast their lots in favor of self-regulation, part of a broad proposal released earlier this year by the Pharmaceutical Research and Manufacturers of America.

"Self-regulation, in many instances, is much more effective than anything the government can do," Hoffman said. "We hope that this view prevails."