Pharmacyclics, The FDA And The Deadly Dilemma

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richard-miller.jpgFor the past year, Richard Miller has waged a public relations campaign to force the FDA to change its ways. As the ceo of Pharmacyclics, he is particularly frustrated that his little company’s cancer med was shot down last winter. Miller has refiled an application, but meanwhile, has latched on to an emotional issue for patients - and many investors - who want the FDA to view experimental meds differently than treatments for chronic illnesses.

This view is shared by former FDA commish David Kessler, although a federal appeals court last summer ruled that dying patients don’t have a right to experimental meds not yet approved by the agency. As Miller sees it, though, the FDA has now errs too often on the side of caution, given the safety controversies of the past few years, a refrain heard increasingly by every big pharma ceo. Several times, he’s been given space in the op-ed pages of The Wall Street Journal to press his case and this morning was on CNBC. (Here’s the video).

“The FDA seems to be using a one-size-fits-all approach and seems to be regulating drugs that are intended for serious disease, life-threatening diseases, the same way they might regulate a drug that’s used to treat a headache,” says Miller, who wants the FDA to fast-track more drugs. Miller, by the way, is getting help from Robinson, Lerer & Montgomery, a public relations firm known for crisis management and hard-nosed campaigns. Linda Robinson’s husband, by the way, is Jim Robinson, chairman of Bristol-Myers Squibb.

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