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How Obama’s FDA Keeps Generic Drugs Off the Market

 

By Dr. Scott Gottlieb (original source The Wall Street Journal) 

“One of the biggest factors fueling the angst over drug prices in the U.S. is that some older medicines that should be sold cheaply as generics are still priced very high, often owing to a dwindling number of generic competitors and the rising cost of producing these drugs.Bernie Sanders and Hillary Clinton like to blame generic-company mergers and greedy drugmakers. But a closer look reveals that a series of regulatory policy blunders is at fault.

The modern generic-drug industry emerged after the 1984 Drug Price Competition and Patent Term Restoration Act, better known as Hatch-Waxman. The law created a cheaper and faster path for bringing generic copies of branded drugs to the market. By keeping regulatory barriers low, Hatch-Waxman enabled vigorous competition from multiple firms, each one vying to sell drugs for close to the cost of manufacturing.”

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