Plans to Slash Medical Costs in America Run Into Generic Drug Concerns
- FDA generics push comes amid quality enforcement woes in India
- Agency struggles to keep up with lapses as records destroyed
Photographer: Dhiraj Singh/Bloomberg
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As U.S. regulators push hundreds of new generic drugs to market in an effort to drive down prices, the industry is facing a continuing problem in India, where many copycat medicines are manufactured.
The Food and Drug Administration approved a record 763 generic drugs in the year ending in September 2017. It expects to sign off on even more rivals for branded drugs in 2018. FDA Commissioner Scott Gottlieb has vowed to tackle a lack of competition he has said is “a root cause of high drug prices.”