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The pressures that shape FDA decisions

Congress publicly frets about how quickly or slowly the Food and Drug Administration approves prescription drugs.

''Inside the FDA," by veteran healthcare writer Fran Hawthorne, is a meandering tome about the undercurrent of business and politics that shapes the regulatory agency's decisions. The book is at its best when it reveals true ''insider" nuggets such as when drug companies tap members of Congress to lobby the FDA commissioner for a specific drug's quicker approval.

That's what Bill Vodra, an attorney who once represented the FDA and now works for the drug industry, says in the book.

''The Washington representatives of drug companies have told me, 'We've got So-and-So (member of Congress) primed to call (the FDA) if we need him,' " he says. The lawmaker's tack: ''This company is in my district, you've had the application for 90 days; is this some sort of bureaucratic hustle?"

FDA superiors say pressure from folks who approve their budget rarely forces their hand. But truth has many faces. Steve Koepke, a former FDA drug reviewer, three times in nine years was called to the commissioner's office for a conference call with a congressional aide.

The tease has the reader coughing through smoke but never ultimately finding a fire. Neither Koepke nor the FDA commissioner at the time, Michael Friedman, would name a drug, company, or member of Congress responsible for the behind-the-scenes pressure.

The book is ambitious in attempting to cover the first 100 years of the FDA's history and in pointing to challenges in the upcoming century for an agency that regulates $1 trillion in products each year. It's a carefully researched primer that arrives as Congress is poised to bolster the FDA's ability to ensure drug safety.

But the narrative feels disjointed. Chapters explaining how the FDA reviews drug applications, how persnickety it is about detail, the powerful pharmaceutical industry, and whether FDA scientists are savvy enough to handle the next generation of drugs could be puzzle pieces. Once the author has them all on the table, they could reveal a larger, comprehensive picture. Instead, each chapter feels like an island with no bridge linking it to the next.

Still, the book is worth reading for raising the curtain on skirmishes for such blockbuster drugs as Lipitor.

How did the company coax the FDA to give it a speedy review when four similar drugs were on the market?

The company sent a persuasive army of 10 to vie with the FDA's army of 10. They faced off for nearly two hours. FDA's bottom line: ''Better doesn't get you faster. It has to be significantly different," said Dr. Irwin Martin, then vice president of regulatory affairs at the Parke-Davis research division of Warner-Lambert.

The company had a plan. Ten children in South Africa with a rare genetic defect leaving them unable to clear cholesterol had bad cholesterol lowered by up to 40 percent by Lipitor. Only 100 American children had such genuine medical need for the drug. But the company revised its application to include them in a clinical trial.

''That was a bit of a stretch," Martin admitted.

Still, Lipitor got its priority review.

Diedtra Henderson can be reached at

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