PhRMA Guidelines: New DTC advertising rules alter drug-sales landscape

To remedy waning consumer trust, the pharma industry's trade group is prescribing that companies shift the focus of marketing from sales to education.

To remedy waning consumer trust, the pharma industry's trade group is prescribing that companies shift the focus of marketing from sales to education.

The Pharmaceutical Research and Manufacturers Association (PhRMA) is calling for more serious, more educational, and more balanced marketing communications.

This month, the group released voluntary "guiding principles" for direct-to-consumer (DTC) advertising that respond to many of the criticisms hurled at the industry in recent years.

They are likely to impact not only industry advertising, but also the entire philosophy behind how pharmaceutical companies communicate.

The guidelines call on companies to submit all advertising material to the Food and Drug Administration before launches, do away with so-called "reminder" ads, present a balanced view of risks and benefits, and spend "an appropriate time" educating doctors about new products ahead of the consumer push.

In addition, the guidelines emphasize more time spent on disease awareness - rather than just on promoting a specific product - and fostering relationships between doctors and patients.

"That's exactly what PR does best," says Michael Durand, global healthcare practice director at Porter Novelli. "The impact [of the guidelines] on the PR industry will be subtle."

New direction for comms

The overarching principles behind the new guidelines have changed the tone of all types of outreach. As surveys indicate low levels of trust and confidence in the pharma industry, companies have been more cautious in how they present themselves and their products.

"We're being a bit more conservative," Durand says. "There has been less naivete about what PR can and cannot do, and the appropriateness of communicating risk."

He notes that, in the same way that companies are encouraged to submit advertising material to the FDA for review, many will also choose to submit their video news releases for pre-approval.

In addition, many companies have nixed celebrities as central spokespeople - unless they have a personal connection with the affliction in question - and are putting more resources into grassroots outreach, ally development, and web-based forums. "It's not replacing advertising; it's adding to it," says Julianna Richter, SVP at Edelman. "We sort of look at it as closing the promotion-education gap."

Michal Fishman, director of US pharmaceutical public affairs at Pfizer, describes the changes in marketing communications as an "evolution" or a gradual shift.

"The whole organization is going through changes," she says. "We haven't had a specific conversation with our agencies as of yet, but ... there is an understanding across the company that consumers [seek] clearer information on risks and benefits."

The recall of Merck's painkiller Vioxx, and subsequent questions about the entire class of cox-2 inhibitors, spurred consumers to scrutinize the credibility of the sources delivering risk information. TV spots are typically ranked among the least trustworthy for delivering a balanced view of risks and benefits.

"I am seeing companies take a long, hard look at DTC advertising from an ROI perspective, as well as from a risk communications perspective," says Nancy Bacher Long, president of Dorland Global Public Relations. "PR used to be seen as adjunctive to advertising. The reality is, we have to look at different ways to get people's attention."

She notes that more clients are opting to hold DTC events, such as disease screening clinics where companies partner with physicians and advocacy groups.

"You're doing an outreach program to broaden disease awareness and, in turn, broaden product awareness," she says, adding that the guidelines could encourage a greater convergence of marketing disciplines.

Peter Pitts, SVP of global health affairs at MS&L, notes that it's "inevitable" that more attention - and perhaps, by extension, a greater share of the budget - will be put into non-advertising outreach.

"We're moving from hard sell ... to educational sell," he says. "PR is extraordinarily well-positioned because it's what we do now. Advertising ... might not be the most potent or precise medium to do that."

But there is disagreement about whether the guidelines will change how marketing budgets are sliced and diced. "PR works best in tandem with advertising, not as a substitute," Durand says.

Andy Izquierdo, federal government PR manager at AstraZeneca, also notes that the goal is to create more effective DTC advertising, not curtail it.

"I don't know about replacing ads; we view DTC as a place to begin that dialogue between patients and doctors," he says. "It's about finding the right patients and matching them with the right medicine at the right time."

Pitts, a former associate commissioner for external communications at the FDA, notes that the most significant components of the PhRMA principles are the recommendations that companies stop using "reminder" ads, as well as a move from what he describes as "sell, sell, sell" to "sell, sell, and educate."

Reminder ads encourage patients to talk to their doctors about a specific drug, but do not mention the condition that the product is intended to treat.

"Reminder ads are potent marketing tools, but they don't have a public health benefit," he says, adding that companies will need to stop thinking of product communications from a quarter-to-quarter perspective.

"Clients and advertising and PR agencies need longer-term strategies," he says. "The ROI is a longer-term ROI."

Reaching physicians

After the release of the PhRMA DTC principles, dozens of companies put out releases stating their intention to adopt them. AstraZeneca, for one, is using the guidelines as an opportunity to let the public know that it has listened to its concerns and is addressing them.

The company had already released its own internal advertising guidelines in the early spring after discussions with politicians and third-party groups. But this month it put out a statement about how its new Crestor and Nexium campaigns reflect both its own ad code, as well as the PhRMA principles.

"Everything that AstraZeneca does is done in a responsible manner," Izquierdo says, adding that the company was also the first to put information about patient assistance programs in its product ads. "We're proud of that. Our goal is to be seen [as a company that is] all about patient health."

Izquierdo notes that if the new ads are designed to encourage conversations between doctors and patients, companies must make sure they are educating physicians at the same speed as consumers.

And Durand agrees that companies are beginning to rethink not just DTC, but also direct-to-physician communication.

"It's going to put a lot more emphasis on reaching physicians quickly and efficiently," he says, adding that communicators are looking at new technologies (such as e-mail or PDAs) to send information out directly to doctors. "That will help defuse this issue that patients know about new developments before doctors do."

The issue of the last-to-know physician has been the leading message from critics of the drug industry's marketing tactics. Sen. Bill Frist (R-TN), citing that concern, last month asked the industry to instate a voluntary two- year moratorium on ads for new products. Bristol-Myers Squibb in June became the first company to self-impose a one-year moratorium.

But Durand notes that an ad restriction "doesn't guarantee that a doctor is more aware of a treatment," and adds that companies will need to find new ways of reaching the medical community beyond trade media and sales representatives.

PhRMA's guidelines similarly stop short of calling for moratoria on advertising. And it remains to be seen whether the new guidelines - and the DTC changes they spur - will go far enough to restore trust in the drug industry.

Richter notes that - in the short term, at least - if the industry hadn't acted on the concerns of its critics, Congress would have eventually decided to step in.

"Activists in Congress will never be happy with self-regulation," Durand says. But the guidelines give companies "a level playing field on which to communicate with the public."

"The issues that surround the pieces of the trust puzzle go far beyond DTC concerns," Long says.

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