FDA's not-so-secret weapon

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Pity Nancy Ostrove. as chief of the government branch that oversees direct-to-consumer prescription drug advertising, she's had two of her favorite entertainment options--TV and pop songs-lose some of their luster. * With the post-1997 boom in DTC broadcast ads, Ms. Ostrove says, maybe only half-jokingly, she can no longer tune in to prime-time TV and forget about her workday. It's tough for anyone to watch TV these days without seeing spots for drugs from Allegra to Zocor. But for Ms. Ostrove, that comes after spending her days at the Food & Drug Administration dissecting and debating the finer points of those ads: every side effect listed, every claim made.

"Oh, can't I just get away from my job?" she'll say as another commercial plays during a favorite show.

Then, there's the question of some of her favorite songs. Every time a pharmaceutical company turns to a pop tune for a DTC ad jingle-Schering-Plough Corp. alone has used at least three for Claritin: "Blue Skies," "Walking on Sunshine" and "After Midnight"--Ms. Ostrove just shakes her head.

"We've been disillusioned," she says, tongue-in-cheek. "They've taken all of our favorite songs and ruined them."

If the stereotype of a government regulator is no-nonsense, staid and all-buttoned-up, the 51-year-old Ms. Ostrove and her wry sense of humor offer contraindications. She's even been known to poke a little fun at the federal bureaucracy, beginning one talk to industry executives with: "I'm from the government and I'm here to help."

Ms. Ostrove also has a more serious side, where she's a stickler for detail and passionate about enforcing the regulations for DTC ads. In that role, Ms. Ostrove has gained considerable influence in the advertising world.

Her title-chief of the FDA's research and review branch of its Division of Drug Marketing, Advertising & Communications-makes her the principal government gatekeeper on DTC advertising. Her scope includes all DTC advertising including Internet marketing efforts.

Drug marketers voluntarily submit prospective ads to her office looking to gain the FDA's blessing before they launch a campaign, and her office can effectively yank an effort out of circulation once it takes flight. Since the FDA oversees just about every aspect of the pharmaceutical business-most importantly which drugs are put on the market-pharmaceutical companies are wary of provoking the FDA at any level. That gives Ms. Ostrove tremendous sway.

"The pharmaceutical firms regard her views as being exceedingly and overwhelmingly important," says Jack Calfee, a former Federal Trade Commission official and the author of "Prices, Markets & the Pharmaceutical Revolution."

"The FDA has far more influence than the FTC [a broader government overseer of deceptive ads] has ever had on anything that it looks at," Mr. Calfee says. "If there's something about ads that she and her staff don't like, they're going to change the ads."

As a result, Ms. Ostrove and her staff have considerable impact on the profit levels of the blue-chip pharmaceutical companies, which are increasingly citing DTC as a revenue driver. A delay in a critical campaign-either during the voluntary pre-clearance process or if an ad is forced out of circulation-can slow a drug's sales growth.

The FDA's reach also stretches deep into the advertising agency world, where government objections to ad content may force creative staff members to edit and re-edit copy many times over.

Though Ms. Ostrove has been with the FDA since 1989, it is only in the last four years that she has emerged as such an important player in drug marketing. It started in 1997 when she laid the groundwork for the FDA's landmark decision to loosen its rules for broadcast "product claim" ads-where a brand is touted as a treatment for a specific condition. That opened the door for a Claritin ad to go beyond mentioning only the brand name, but identify the product as an allergy drug.

Ms. Ostrove says the decision was made because the FDA saw a public benefit in increased information to consumers. Also, the FDA may have felt pressure to try to assert some control over the inevitable. Increasingly, the FDA saw marketing-focused drug companies-most notably then Hoechst Marion Roussel (now Aventis) with an ad for Allegra-push the boundaries with so-called "reminder" ads, which are prohibited from making claims for drugs. Thus, the FDA wanted to lay out some ground rules.

"I think Hoechst should be given some credit for contributing to this," Ms. Ostrove says.

Largely a gift to marketers, the 1997 ruling gave them a new avenue to plug their products and led to the flurry of DTC TV commercials.

"We knew it would open the floodgates," Ms. Ostrove says.

It also increased her workload. Last year, her department reviewed 443 TV spots, most before they went on the air. Marketers, looking to avoid public relations problems or launching a campaign and having it scuttled, or both, took advantage of the FDA's pre-clearance process where the agency will review ads and work with a drug company to reach a point where the FDA gives its imprimatur on the content.

The 1997 rules, though, were technically only preliminary, and in 1999, Ms. Ostrove helped the FDA bring them to final form. No significant changes were made, leading to a sigh of relief from contented marketers. But later this year, attention will again shift to Ms. Ostrove as the FDA collects data and issues its evaluation of how the rules are working. That could lead to some changes if the FDA finds the ads are having a negative impact on consumers.

"The data that are out there now don't seem to suggest that the public health is being harmed," she says. But she also suggests the FDA isn't entirely pleased with what has unfolded over the last four years.


"I'm not satisfied with what has resulted," she says in an interview at FDA headquarters-a building that looks and feels like a hospital-in Rockville, Md. "I think the drug companies have been unbelievably selfish."

Specifically, Ms. Ostrove says she feels marketers have overly touted a drug's benefits in product-claim ads while trying to diminish the potential side effects. Broadcast advertising making a claim about what a drug might do must mention a drug's major risks.

"They try to overstate-overpromise-the efficacy of a product, while at the same time [trying] to minimize the risk, though they're doing less of that now," she says. "But this overstatement of efficacy is getting to be a big problem as far as I'm concerned." Further, she says, drug companies are misusing two other kinds of ads: reminder and help-seeking spots.

Since reminder ads only plug a brand name and don't mention what a drug treats, they are exempt from the side-effect listing policy. Help-seeking ads don't mention a brand name at all but attempt to prompt people to visit a doctor for treatment for a particular condition.

Ms. Ostrove says drug companies are increasingly airing a reminder and a help-seeking ad-which often share images and tones as part of a campaign-during the same commercial break, hoping consumers will make the connection between the brand name and the condition it treats. She says legally the FDA cannot prohibit it, but the reminder and help-seeking ads were intended to be distinct from one another.


"They're really pushing the envelope on both reminders and help-seeking advertisements because . . . they don't want to talk about the side effects," she says.

FDA officials see themselves as guardians of the public health, leading to an inherent conflict with marketers looking to sell products. This clash has taken on new dimensions in recent years as the quality of DTC ads has improved and the pharmaceutical companies have added marketing strategies such as celebrity endorsers and catchy pop-song-derived jingles.

"There's always going to be tension between the two forces," says Bob Ehrlich, a former Warner-Lambert Co. executive who's now CEO at DTC consultancy Rx Insight.

Ad agency executives who declined to speak for attribution say they've had to alter prospective ads for reasons such as a cast that appeared too good-looking or too happy according to the FDA.

"The FDA steps over the line when they get into issues of truly creative commentary as opposed to just what the spot is communicating," one executive says.

"They look at things the FDA is not really qualified to review," says Sandi Dennis, an attorney at the Washington law firm of Morgan, Lewis & Bockius who advises clients on advertising approval. "I think they're really projecting when they do things like say that use of a male voice vs. a female voice presents a different message."

Ms. Ostrove says the FDA is wary of its image and wants to avoid being viewed as overzealous but has obligations to ensure consumers aren't getting an outsized message.

"We're concerned that we don't undermine our credibility," she says. "We sometimes talk about not wanting to be too pointy-headed, which is our way of saying that we're focusing on unimportant things."


Personally, Ms. Ostrove, who holds a Ph.D in social psychology, gets high marks for being even-handed from DTC executives.

"She has a very good sense of balance," says Michael Shaw, executive director of EthicAd, a non-profit group that tries to promote DTC as a public health communications medium. "She tries very hard to understand industry's position, and she's in tune with their needs. But she's also very savvy. She understands when agencies are trying to push the envelope or are trying to sneak things through with artistic devices."

Since 1997, ad agency executives say they have gained a general understanding of what the FDA will approve and what it won't-though they say there are inconsistencies. Figures from the FDA show the number of letters forcing marketers to alter broadcast product-claim ads has gone down from 13 in 1998, the first full year of the new regulations, to four in 1999, though the total went back up to eight in 2000. But letters on reminder ads have risen from none in 1998 and two in 1999 to seven in 2000.

"We've tried to be very consistent on broadcast ads," Ms. Ostrove says. "It's impossible to be completely consistent. They'll look at things, and they'll interpret them one way, and we'll look at it and interpret it another way. That's not a lack of consistency as far as we're concerned."

One agency executive says, however, the FDA may hold drug companies that have shown a tendency to take risks to a different standard.

"If it's a company that has tried to push the envelope before and has been perceived by the FDA folks as not complying or trying to push the envelope too far, they might scrutinize an ad more than they would for people who have generally complied," the executive says.

Speed is another issue where Ms. Ostrove says the FDA has made an effort to be consistent. The agency tries to provide comment to marketers on prereleased ads within 20 days and tries to do the same once marketers have revised the content.

"They've gotten much faster," an agency executive says, though she adds there are fluctuations.

Despite the inescapable tug of war, some agency executives and Ms. Ostrove say the two sides have found some common ground.


"They clearly are trying to protect the public's interest and the physician's interest in terms of drugs not overstating efficacy and not underplaying side effects," one executive says. "As much as they make me nuts sometimes, I think overall they do the right thing. Sometimes within that, just like any judicial process, rulings are too harsh and sometimes they're too lenient."

Allowing her sense of humor to resurface, Ms. Ostrove says she's happiest when there's some discontent.

"As soon as you're seen as being too open to the industry, that means a lot of people will interpret that as meaning you're not for the consumer," she says. "There tend to be these real dichotomous ways of looking at you. In a joking fashion, I say I generally know we're going in the right direction when everyone is angry with us."

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