The Food and Drug Administration approved or tentatively approved a record 126 generic drugs in July, the agency reported Thursday, an indication that Republicans are getting the faster approvals they have sought.
The agency approved 96 generic drugs and gave a tentative approval to 30 more in July, according to monthly data. Greater generic competition with pricier brand-name drugs is often thought to be a critical factor in improving drug prices.
FDA Commissioner Scott Gottlieb tweeted on Thursday that the total was the highest monthly amount ever in the history of the generic drug program.
[Previous coverage: FDA to call out brand name drug companies that block generics]
GENERIC DRUG NEWS: #FDA beat another record. July saw the highest number of approval actions in the history of the generic drugs program in a single month with 126 total approvals (96 full approvals + 30 tentative approvals) https://t.co/vaSzgrHkyJ pic.twitter.com/t9AUXoicat
— Scott Gottlieb, M.D. (@SGottliebFDA) August 9, 2018
The Trump administration and congressional Republicans often argue that greater generic competition will lower prescription drug prices.
[Also read: Trump teases announcement that will lower prescription drug prices]
Generic approval times have lowered in recent years in part due to the installation of a user fee program through which generic drug companies pay the FDA every time they submit a new application for approval. The FDA in turn uses that money to hire new staff and improve the drug approval process.
The FDA has a goal to review all generic drug applications within 10 months of submission to the agency. Before the first user fee program was implemented in 2012, the agency previously had a backlog of more than 10,000 applications awaiting approval.
