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Abuses of FDA Regulatory Procedures - The Case of Suboxone.

Haffajee RL, Frank RG.

N Engl J Med. 2020 Feb 6;382(6):496-498. doi: 10.1056/NEJMp1906680. 

The manufacturer of brand-name buprenorphine products exploited various FDA regulatory procedures to impede market entry of generic competitors and to maintain high prices. This case provides an example of the kinds of abuses that are common in prescription-drug markets.