Bloomberg Law
March 7, 2018, 10:36 PM UTC

‘Rigged’ System Blocks Lower-Cost Drugs, Head of FDA Says

Anna Edney

• Gottlieb blames PBM rebate tactics for weak biosimilar market

FDA has approved nine biosimilars, only three for sale in U.S.

A “rigged payment scheme” between drug plans, insurers and pharmaceutical companies has blocked access to less-expensive versions of some of the most costly drugs in the U.S., the head of the Food and Drug Administration said Wednesday.

FDA Commissioner Scott Gottlieb aimed particular criticism at giant pharmacy benefit managers that contract with health plans to administer coverage of drugs, saying the industry’s tactics have stymied cheaper copies of expensive biotechnology drugs. Known as PBMs, the companies include Express Scripts Holding Co., CVS Health Corp. ...

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