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Why Plan B Matters

Executive Summary

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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Forced to Act: Omnitrope and the Battle for an FDA Commissioner

Generic biologics was not a priority for Andrew von Eschenbach when he accepted the job as acting commissioner of FDA. But two events -- a federal court ruling requiring a decision on Sandoz' Omnitrope NDA and the European Union approval of the follow-on biologic -- mean FDA may be pressed to take action on a regulatory pathway. The Omnitrope ruling makes it more important than ever that FDA have a fully confirmed leader in place, but it will also make it harder to get one.

The HPV Vaccine Race

GlaxoSmithKline has some catching up to do in the race for what promises to be the world's biggest dollar-volume vaccine market. The company's human papilloma virus vaccine, Cervarix, is a year behind Merck's Gardasil in clinical development. The outcome of the race is by no means a foregone conclusion, however; development strategies, and how the social-conservative card plays out--will decide the winner in the newest vaccine market.

Texas Justice and the Industry's Image

With its $253 million judgment against Merck & Co. Inc. (reduced to $26.1 million under Texas law), the jury "sent a message" about what it perceived as the pharmaceutical industry's culture of greed. Ironically Merck's liability gives it a rare opportunity to right the ship. But will industry's tarnished image impede the approval and use of Merck's most important upcoming product, the HPV vaccine Gardasil?

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