FDA / Trump ...en genéricos.

“Our work is not done. 

We’ll continue taking additional steps 

to help ensure patients have access 

to the drugs they need 

by making generic drug approval 

more efficient and predictable. 

We are doing this by continuing 

to streamline the generic drug review process 

to get more competitors on the market. 

We have found 
that having three or more generic competitors

 brings prices down more sharply

 than with only one or two generic competitors.”

Scott Gottlieb FDA Commissioner

 

PWC Study on Faster Approval of Generic Drugs 



The FDA has substantial new authority, resources and resolve to make it easier for generics to come to market, viewing competition as a key way to bring down drug prices. These efforts likely will succeed in bringing new generics to the market more quickly and predictably, but significant competitive hurdles may limit their impact on drug pricing or competition without complementary efforts to address the biologics market. Already, the FDA is setting records for the number and speed of its generic drug approvals. The FDA fully approved 763 generic drugs in fiscal year 2017, according to an analysis by PwC’s Health Research Institute (HRI). That is 86.5 percent more than in fiscal year 2014, the first full year the Generic Drug User Fee Act was in effect, when it approved 409 (see Figure 1). And the agency is approving these drugs faster than it was even a few years ago. 

For some generics, approvals are coming in as few as eight months instead of the previous standard of 15 months in fiscal year 2016. (Más)