Posted by Michael Wonder on 14 Oct 2019
FDA bid to bolster generic competition and combat shortages isn’t working — yet
14 October 2019 - Although the FDA has maintained that additional generic approvals should promote competition and alleviate shortages, the proportion of approvals for drugs that could address those concerns has actually remained steady, according to a new report.
From July 2016 to December 2018, the total number of generic drug applications approved by the agency gradually increased during most quarters, from 133 to 262.
Of the 1,832 generics approved during that time, 20.4% faced limited competition at the time of the approval, and 39.1% had experienced a shortage in the previous five years.
