After a snowed FDA announced plans to add fees on top of fees--by asking industry to partially cover review costs for television ads, in addition to those it's already required to pay as part of the Prescription Drug User Fee Act (PDUFA)--consumers were less enthusiastic than industry hoped they would be.

Patient advocates still don't believe that the changes go far enough to address their concerns. They want the funds to come from government--not industry--in order to keep an uncompromised distance between the two. And Consumers Union stressed that while speedier reviews might catch offenders in earlier stages of their campaigns, they don't keep the offending ads off the airwaves during the review process.

Still, industry leaders seemed pleased with the change, implemented to help FDA keep up with the mountain of drug-advertising material it needs to check each year. Flashy DTC ads have been blamed for creating mass-market demand for expensive or risky drugs that might be appropriate only for a small segment of the population--and drug company reputations have suffered as a result. PhRMA, which has tried to address the criticism by issuing a voluntary marketing code for the industry, trumpeted the additional fees as "an important new step."

The agency is asking for an extra $6.2 million in user fees from companies that want to advertise their drugs on television. The funds will support the addition of 27 more staff members to help FDA sort through a volume of marketing material that roughly doubled between 2002 and 2005.

There are limits to what the fees can accomplish, noted Peter Pitts, a former associate commissioner for external relations at FDA. "Right now, any review of promotional material is strictly optional," he said. "All it does is allow FDA to review ads with greater with alacrity."

Moreover, the fees don't address a larger issue for industry: a single standard for how the agency rules on ads. Pitts noted that some of the ads that receive warning letters are initially OK-ed by the agency. "There's no bright line; there's no consistency," he said. "It's not hard science; it's social science. DDMAC is soft on social science."

Although word of the new fee has been making its way through the rumor mill over the past several months, its official introduction comes just weeks after the Government Accountability Office (GAO) chastised FDA for oversight efforts that are slow and clumsy. The critical GAO report found that FDA is sending out fewer warning letters to rule breakers and taking longer to do so--so long, in fact, that about half of the inappropriate ads are out of circulation by the time marketers receive a warning.

FDA is still struggling with how to put more teeth into its warnings. A 2002 policy change required its Office of Chief Counsel to approve all warning letters--hoping to put the fear of legal action into marketers' hearts--but the change just slowed down the review process.

Articles

Consumers still aren't happy, but industry calls FDA's addition to PDUFA 'an important new step.'

You Can't Please Everyone

A company needs to be bold to launch a product in the hypertension market, a crowded category under pressure from generics and poor patient compliance. Undeterred, Novartis is gearing up to launch its newest combination therapy complete with a multi-brand marketing blitz boasting community outreach, disease awareness, and a celebrity spokesperson.

The Swiss drug giant is banking on its tentatively approved drug Exforge to pump up the sluggish high-blood-pressure market. The approval is tentative because Novartis must wait to launch the product until September, when key ingredient amlodipine (currently marketed by Pfizer as Norvasc) goes off patent. Exforge combines Norvasc with Novartis' own Diovan (valsartan), the two best-selling drugs in their categories. Taking the two drugs together not only has an additive effect but reduces the common side effect of edema, according to Mark Iwicki, vice president of the cardiovascular metabolic brand team.

Agencies Deutsch and Integrated Communications are teaming up with Novartis to kick off the Exforge campaign after the product debuts in the fourth quarter of this year. The company intends to keep busy until launch time introducing the drug to doctors at medical meetings.

The hypertension market grew by just 4.3 percent in 2005, and five-year forecasts aren't much brighter--mostly due to the intense generic competition and a lack of new R&D targets, according to market research firm Datamonitor. "Most of these products have run their course," said Laura Greenwood, an associate analyst. "You might say the hypertension market is reaching the end of its cycle. There's no unmet need."

As a result, companies are turning to combination therapies, one of the market's fastest-growing segments. With Exforge, Novartis is hoping to target the 70 percent of hypertensive patients who need at least two medications to control their blood pressure, according to Iwicki.

But compliance may be a higher hurdle than efficacy. While a two-in-one pill is a significant advance in convenience, no combo can alter the fact that without telltale hypertensive aches and pains interrupting their lives, many patients tend to skip doses or worse, especially when side effects show up. "It's quite common that they stop taking their products," Greenwood said.

The compliance conundrum is something Novartis has been addressing across its blood-pressure portfolio. Its BP Success Zone, which spans brands, is a campaign to raise awareness about hypertension--with NFL Hall of Famer Joe Montana as its celebrity persona. Patients on a Novartis' hypertension drug receive customized educational information each month. "We'd expect to do something similar with Exforge," Iwicki said.

Novartis in November also designed 3-D graphics illustrating the havoc that uncontrolled high pressure can wreak on the body; dubbed "Dialogues," these visual aids are meant to help doctors drive home the point about why it's important for patients to adhere to therapy. A Novartis-commissioned survey found, for instance, that while 85 percent of doctors believe they are fully explaining the risks of hypertension, only 50 percent of patients are taking their medications correctly.

Greenwood was conservative about Exforge's market potential. "We have forecasted that Exforge will be a popular drug but may not be a blockbuster," she said, noting that a Datamonitor analysis of Novartis' pipeline shows a recent shift away from the cardio market toward more lucrative fields, particularly oncology, where it can expect a greater return on investment.Iwicki disagreed with the projections. "This is a really robust market," he said. "We're in this for the long run."

Novartis' upcoming anti-hypertension combo and campaign target noncompliance.

Teaching an Old Market New Tricks

Pharma's reputation woes are a danger to its bottom line--and industry leaders aren't even aware of the size of the problem, according to a study released by PricewaterhouseCoopers. The nationwide survey of 500 consumers and 150 executives found that the two groups have vastly different perceptions of drug companies' trustworthiness, honesty, goodwill, and financial motivations.

It's no surprise that consumers don't think too highly of pharma. Nor is it news that company heads express confidence in industry values. What's surprising is how little the two points of view have in common. According to the report, 45 percent of consumers believe companies are more interested in developing "me too" and lifestyle drugs than innovative products, 62 percent believe they manipulate clinical data, and 94 percent believe they're too aggressive in promoting drugs off-label. By contrast, 91 percent of pharma executives say they are developing drugs for unmet health needs, 80 percent believe in the sanctity of clinical data, and 53 percent believes the industry abides by off-label promotion rules.

Consumers often don't understand what makes a follow-on drug unique from its competitors, said Brian Riewerts, a partner in PWC's pharmaceutical and life sciences advisory-services group. "That goes to the heart of the definition of innovation."

Whether accurate or not, public perception seems to be a growing force in the consumer-directed healthcare model--with a direct impact on a company's revenues. The survey's most important finding may be that corporate brands matter as much to consumers as product brands--with 78 percent of consumers saying that when given a choice, they consider a company's reputation before taking a drug. A 5 percent positive change in corporate reputation can translate into a 3 to 5 percent change in market capitalization, the PWC report found, citing data from the Research Institute, an independent organization. And yet the study found that two-thirds of execs remain convinced of the conventional wisdom that corporate reputation is not a factor in drug selection, with most leaders still skeptical that consumers even knew which companies produce which products.

"This is a bell that's ringing that we need to pay attention to," Riewerts said. He predicted that consumers will become even more savvy about who the players are in the drug industry as they begin to pay more of their own healthcare bills.

Under the leadership of Billy Tauzin, PhRMA has launched a series of campaigns to improve the reputation of the drug industry. Where the trade group was once considered something of a black hole among reporters, PhRMA now boasts TV, radio, and at least two educational Web sites that promote disease awareness, patient assistance programs, and the investments that are being made in R&D. And then there's Montel Williams--the drug industry's celebrity champion. Companies such as GlaxoSmithKline, Bayer, and Merck have also undertaken their own corporate-image initiatives to highlight their science-based mission.

Whether these efforts will succeed in restoring consumer confidence while drug safety and pricing remain hot-button issues is uncertain. "The challenge for many of our clients is that consumers are still concerned about issues that industry has tried to address," said Riewerts, noting that changes to DTC marketing--like doing away with "reminder" ads and imposing six-month "quiet periods" before new DTC campaigns--haven't stemmed criticism of the practice.

Consumers also underestimate the cost of bringing drugs to market by more than 50 percent.

Trust in healthcare, and especially pharma, has been in steady decline over the past 10 years, according to a separate report from Ernst & Young. That study found that trust is higher in countries with blanket drug coverage--suggesting that anxiety over cost and access still very much color how the public views the industry, and may have to be resolved before reputations improve.

Consumers say no, and they're watching which companies are naughty or nice.

Pharmaceutical Executive-01-17-2007

You Can't Please Everyone

Teaching an Old Market New Tricks

In Pharma We Trust?