Can Pharma Survive DTC Ad Restrictions?

(MoneyWatch)  The rise of the modern pharmaceutical industry is closely intertwined with the advent of "direct-to-consumer" advertising -- those ubiquitous TV and magazine ads for antidepressants, sleep aids, erectile-dysfunction drugs and a whole slew of other treatments.

In fact, it's hard to imagine how the industry could ever have grown to its current size without them, given the major role such ads have played in motivating anxious patients to demand new prescriptions from their doctors. (Or, if you believe the industry, the role they've played in providing consumers with information they otherwise wouldn't have come across.) DTC ads are almost uniquely American -- the only other country that even allows them is New Zealand -- and while their effectiveness is hard to measure directly, it's clear that pharma thinks they work, since drugmakers dumped roughly $3.5 billion into DTC last year.

But the freewheeling days of pharma's DTC ads may be drawing to a close. Measures intended to give the Food and Drug Administration new powers to regulate drug ads dropped out of a major FDA-reform bill last year, but Congress is again making noises about curbing drugmakers' freedom to run ads that tout benefits of their drugs while minimizing their possible dangers. Last Thursday, for instance, Rep. Bart Stupak, a Michigan Democrat who heads a key congressional oversight panel, fired this shot across the bow of the industry at a hearing focused on DTC abuses:

"It appears that we need to enforce significant restrictions on DTC (direct-to-consumer) ads to protect American consumers from manipulative commercials designed to mislead and deceive for the profit of pharmaceutical companies," said Stupak, head of the U.S. House of Representatives Energy and Commerce investigative panel.

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"Pharmaceutical companies should consider it a privilege to be allowed to air DTC ads in this country," he said. "We should make sure that pharmaceuticals companies conduct themselves responsibly."

The FDA is looking at its own potential reforms, especially the possibility of requiring drugmakers to prominently display a toll-free number at which consumers could report side effects in TV ads (they're already required in print). Not that the agency is exactly moving at warp speed. At an FDA advisory-panel meeting last Friday, the assembled experts discussed ways to design a study that might determine the best way to add such a number to TV ads:

FDA spokeswoman Rita Chappelle said the agency would look at the panel's recommendations and incorporate them into the design of a study to determine the best way to include a toll-free number in TV ads. After the study is done, the next step would be to issue regulations and get Congressional approval before they could take effect, she said.

"It could take some time," Chappelle said. "It could take a couple of years."

Chappelle noted that because television is a different medium from print, the best way to put a toll-free number on television ads needs to be studied. Among the factors that require consideration are the best place to put the number and how long it should stay on the screen, she said.

But of course --it wouldn't do for the FDA to act too hastily. (Apparently the idea of conducting such a study in parallel with new rules is alien to the FDA's bureaucratic -- or political -- masters.)

Don't expect industry to accept new restrictions on DTC without a fight, even if its pull with Congress and the administration isn't what it used to be. Although the latest evidence of how that influence may played out in the past is pretty interesting. Via Gooznews comes a revealing look at how the FDA's legal office, then headed by a political appointee who now represents Johnson & Johnson in private practice, nixed an effort to yank misleading DTC ads for J&J's anemia drug Procrit. While it's not clear that the former official, Dan Troy, played a personal role in the decision, the situation presents some uncomfortable parallels to other cases in which politics has played a role in FDA decisions, such as the agency's long delay in approving over-the-counter sales of the emergency contraceptive Plan B.

Bonus round: The next DTC battleground may well involve medical devices. Writing in the New England Journal of Medicine, two cardiologists sharply criticize DTC ads for J&J's Cypher stent as misleading and potentially dangerous. Given that implanting a stent requires an invasive procedure that carries substantial risks, "the notion that television viewers, inspired by such an ad, would go to their physicians and request not only a stent but a specific brand and model of stent is frightening, if not utterly absurd," the doctors wrote.

Photo by Flickr user Brett L., CC 2.0