43% of generic drugs FDA-approved in the last year — aren’t offered to Americans


Getty/Ute Grabowsky

❝ Of the more than 1,600 generic drugs approved by the Food and Drug Administration since January of 2017, more than 700—or 43 percent—are not for sale in the US, according to a new analysis by Kaiser Health News.

The finding means that many pricy, brand-name drugs are not facing the competition that could help drive down soaring prices. Among the drugs missing in action are generic versions of the expensive blood thinner Brilinta and the HIV medication Truvada. Moreover, of the approved drugs that would offer a brand-name drug its first competition, 36 percent are being held off the market, the analysis found…

Whatever the reason, keeping approved generics from the market is “a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb said…

Generic approvals at the FDA have ramped up in recent years, and the agency is cracking down on anti-competitive tactics, Gottlieb said…

Even when generics grow to play a significant role in market pricing the usual result is a one-third price cut. Experience tells me whatever price cut a national-class company makes – that’s often only half of how much they can afford.

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