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Schering-Plough's About-Face On OTC Claritin

Executive Summary

Just ten months after telling the FDA that granting Claritin OTC status posed a "major health risk," Schering-Plough--threatened by the genericization of its blockbuster drug and possible OTC competitors on the horizon--has changed its tune and asked the agency to approve the switch. Its a move which may presage a sea change in drug marketing as pressure could mount for other NSAs, as well as medications in other therapeutic categories, to go non-prescription.

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Why Plan B Matters

While Barr's attempt to switch the emergency contraceptive Plan B to over-the-counter status is immaterial to the company, the rest of the drug industry can't afford to ignore the controversy, which could jeopardize the renewal of crucial legislation that supports fast and predictable reviews of all new drugs. Moreover, FDA may be reopening old controversies, like whether third parties can force an OTC switch against a brand company's wishes.

Why Plan B Matters

While Barr's attempt to switch the emergency contraceptive Plan B to over-the-counter status is immaterial to the company, the rest of the drug industry can't afford to ignore the controversy, which could jeopardize the renewal of crucial legislation that supports fast and predictable reviews of all new drugs. Moreover, FDA may be reopening old controversies, like whether third parties can force an OTC switch against a brand company's wishes.

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