What To Watch As FDA Begins To Fight Rising Drug Prices

By Sapna Palla and Kristyn Hansen (August 4, 2017, 11:30 AM EDT) -- With the enactment of the Hatch-Waxman Act, Congress spurred generic competitors to enter the market and lower the cost of expensive, brand-name pharmaceuticals. At the same time, to incentivize new drug development, the act provides limited regulatory exclusivity periods for drug innovators.[1] As a product's market exclusivity period wanes, drug innovators may use creative and sometimes controversial means to maintain dominance in the market and keep products free from generic competition. These anti-competitive tactics trigger the involvement of the Federal Trade Commission, but until now, the issue has not similarly stirred the U.S. Food and Drug Administration to action....

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