From Generics to Brands: Barr's Women's Health Franchise
Executive Summary
Barr remains committed to building a leading women's health franchise even as it encounters setbacks, big and small, most recently in the FDA's rejection of its application for over-the-counter status for its emergency contraceptive, Plan B. Even more problematic is the ongoing turmoil in the hormone replacement therapy markets. It recently launched its first proprietary product, indicating its skill in getting an NDA drug through the FDA and newly acquired marketing savvy.
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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.
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.