Like Angell in The Truth About the Drug Companies, Critser traces the big changes in the drug business back to what he calls "newly loosened and speeded-up regulatory processes" that began with the Bayh-Dole Act of 1980, which "made it easier for the industry to use research discoveries that originated in publicly funded laboratories," and the Hatch-Waxman Act of 1984, which made it easier for cheaper generics to find their way to the market but also made it easier for drug companies to get extensions on their monopolies. As for the Prescription Drug User Fee Act, passed in 1992, Critser says it in effect resulted in "a clientized" Food and Drug Administration, by allowing companies to pay "user fees" to expedite the reviews of new drugs.
In recent years, Critser goes on, the two great buffers between Big Pharma and the public have grown increasingly porous. The government, besieged by pharmaceutical lobbyists, has grown more and more accommodating toward drug companies, while doctors -- coping with growing workloads, demanding patients, and the strictures of managed care -- have started to change their prescription-writing habits. Needless to say, Big Pharma has done everything it can to promote its own interests: Critser estimates that the business spends "between US$8,000 and US$15,000 annually per physician to sell its wares."
At the same time, drug companies have employed a host of other strategies to maximize sales and profits: focusing on the development of drugs for chronic conditions and drugs with large patient populations; enlarging the patient base for existing drugs by selling them as cures for related disorders (Paxil, for instance, eventually won approval for treating depression, panic disorder, obsessive-compulsive disorder, and social anxiety disorder); and promoting drugs like Viagra as "quality of life" products that patients would ask their doctors to prescribe.
"The principal forces that have so deeply pharmaceuticalized American life are hardly likely to abate anytime soon," he writes. "Managed care over the next decades will continue to depend heavily upon pills as a proxy for physician care. Cost-conscious employers and insurers will make sure of that. As will Wall Street -- particularly as baby boomers begin to cash in their retirement funds, which have been floating on that nice, easy cushion of double-digit pharmaceutical company returns."
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