FDA Issues Rare Quadruple Warning to Kidney Drug Maker; Next Up, Double-Secret Probation

(MoneyWatch)  It's considered serious when the FDA sends one of its "warning letters" to a drug company. The event can be used in litigation against the firm, or depress its stock. Companies generally comply quickly with the FDA's rockets, which tend to outline one or two ways in which a company has pushed the envelope in its marketing.

But Shire (SHPGY), maker of a treatment for end-stage kidney failure, received an unusual quadruple warning from the FDA over its mismarketing of the drug. The letter was sent last year but was disclosed today.

Call it the drug world's equivalent of turning it up to 11: In a single brochure that Shire gave to its kidney patients about Fosrenol, the FDA said the company committed four separate fouls:

• It left out the risk warnings, which include Crohn's disease and bowel obstruction.
• It said Fosrenol was safer and more effective than other drugs, when the FDA believes there's not enough evidence for that.
• It said Fosrenol could prevent "bone disease, heart disease or death," when there's no evidence for that.
• And it said Shire broadened the approved uses of the drug outside end-stage renal failure.

The only major infraction Shire didn't seem to commit was marketing the drug without FDA approval (something Bayer managed in 2008).

Perhaps the FDA should now put Shire on double-secret probation, the multi-level punishment favored by the Dean of Faber College.

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