Newspaper Article

THE PHARMACEUTICAL INDUSTRY, For consumers, a bitter pill to swallow, How did it become so easy for the drug companies to market their goods? Ask the courts, then the FDA

GREG CRITSER. Greg Critser, author of "Fat Land: How Americans Became the Fattest People in the World" is writing a book about the pharmaceutical industry. This is from the Los Angeles Times

2004

Overview

Liberals and consumer activists might be surprised to learn that a series of court cases initiated by Ralph Nader in the 1970s gave rise to today's reigning legal notions about commercial speech, which supply the legal framework for such things as off-label promotion of drugs (the marketing to doctors of medications for uses other than those approved by the FDA) and direct-to-consumer advertising of prescription drugs. Should a drug company be able to distribute, via highly trained and restrained medical affairs people, studies showing that a drug approved for one purpose also \"seems\" to help kids with, say, end- stage brain cancer, an unapproved use? The average consumer would probably say yes. But the waters quickly get muddier. Should a drug company be allowed, as has been the case with antidepressants, to dispatch tens of thousands of young, barely trained sales reps to give general practitioners studies that \"suggest\" that adult antidepressants \"might\" help kids with depression? The FDA's traditional response was to come down hard on the latter but not on the former, and most of us would be likely to agree with that inclination. The FDA's tolerance of drug company product promotion reached new heights under Bush appointee Mark McClellan, until March the agency's chief. McClellan made clear to the pharmaceutical industry immediately after his appointment that he intended to change the FDA's image. Under him, that image morphed from one of a tough, independent-minded regulatory body to a partner in nurturing pharmaceutical innovation. In Medical Marketing & Media, McClellan could be found with Peter Pitts, his then-new public affairs director, alongside the headline, \"We won't bite.\"

• Publisher: Newsday LLC