Consumerization: Pandora's Pillbox - Pharmaceutical Executive

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Consumerization: Pandora's Pillbox
By going direct-to-consumer, the industry unwittingly unleashed a swarm of opportunities for other players to enter the pharmaceutical fray. And they made the most of it. Now, a decade later, pharma is feeling the fallout in consumer trust and product value. It's time to take back control.


Pharmaceutical Executive


However, according to the Food and Drug Letter, Wellpoint's primary motive was "to save the company about $90 million—$45 million from prescription costs and $45 million for co-pays." Said Fred Weissman, associate dean for academics and clinical affairs at the University of Southern California School of Pharmacy: "Healthcare plans do not want to pay for certain drug categories, which is why they promote the use of some OTCs. When a drug makes the Rx-to-OTC switch, the financial burden is placed on the consumer because OTCs are not covered under the prescription benefit."

Schering-Plough initially opposed the switch because OTC products generally have lower prices and fewer sales. But in 2002, shortly before Claritin was to go off-patent, the firm reversed its position—generic loratadine would soon take a big bite out of its allergy-market share. Moreover, Schering was launching Clarinex, a newer version of Claritin, and did not want a generic to cannibalize the sales of the higher-margin, patent-protected Clarinex.

As a result of the switch, nonprescription Claritin became significantly more expensive for the vast majority of insured patients who previously had been paying low co-pays. "Neither the drug companies nor the insurance companies likely had the best interests of people with allergies in mind...when they pursued the switch to over-the-counter Claritin," stated Vincent Iannelli, MD, associate professor of pediatrics at the University of Texas Southwestern Medical School.

If consumerization is driven by stakeholders in the name of consumers, consumerism, by contrast, is the real thing. A classic illustration of pharmaceutical consumerism occurred when cancer patients and advocates initiated a write-in campaign in the late nineties to prod Novartis to develop STI-571, a promising compound for chronic myelogenous leukemia (CML). At that time, Novartis estimated that CML affected only about 5,000 patients, a too-small market. But the activism proved persuasive—and helped win FDA approval in less than three months for the life-enhancing blockbuster we now know as Gleevec. Novartis CEO Daniel Vasella said, "Normally, it is the company that pushes the most, but in the case of Gleevec, it was the patients who were doing the pushing."

A Stampede of Stakeholders

The sentinel event of consumerization was FDA's landmark 1997 guidance on DTC advertising. This regulatory action—pushed by pharma in order to overcome managed care's increasing restrictions on drug prescribing by physicians—opened a promotional floodgate to consumers. This access enabled the industry to increase sales by enhancing disease awareness and brand identification—and, of course, encouraging viewers to "see your doctor." According to Manhattan Research, more than 80 percent of consumers who (appropriately) requested a specific brand from their physicians received those prescriptions. Industry spending soared from $791 million in 1996 to more than $5 billion today.

But DTC advertising is far from the only way the industry has propelled pharmaceutical consumerization. Several key developments over the past decade were sparked, in part, by the process. The investment in producing "lifestyle drugs" for conditions like erectile dysfunction (ED), hair loss, and facial wrinkles tops the list. Firms have also mastered the art of life cycle management, extending franchises with reformulations, new applications, and even pushing for Rx-to-OTC switches.

Third-party payers were quick to see the cost-controlling potential of consumerization. Insurers, governments, pharmacy benefit managers, and employers have all been busy finding new ways to shift more of the price burden to consumers. Healthcare plans increasingly restrict use of brands that are new or expensive by limiting formulary choices. Even Medicare Part D contains the infamous "doughnut hole" coverage gap. All of these measures favor the increased use of generics and older, cheaper drugs, regardless of patient need.

Consumerization has extended well beyond the stakeholders who are making and selling drugs. Politicians on both sides of the aisle have been ramping up the rhetoric about a host of industry issues. With the recent Democratic takeover of Congress and the upcoming presidential election, politicians are consumerizing pharmaceuticals for campaign platforms and garnering votes by focusing on a Big Pharma laundry list, including pricing, safety, DTC ads, drug importation, and FDA reform.


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