Legal News

FDA Acts On Generic Drug Safety

July 25, 2018

The U.S Food and Drug Administration (FDA) has finally agreed to look at the huge safety discrepancy between generic and brand named drugs. The FDA signaled the move by notifying the Office of Management and Budget of its plans to publish a proposed new rule that would make create similar requirements for generic and brand-name drug makers with respect to how they update their warning labels.
Currently, only brand drug makers can legally update their warning labels if they learn of new or undisclosed risks. This means generic drug makers effectively have no responsibility to monitor the drugs they sell for safety, because the company has no responsibility to warn about new risks.
Public Citizen first raised the issue with the FDA in a Citizen Petition back in August, 2011 after the U.S. Supreme Court ruled that generic drug makers cannot be held responsible for their drugs’ safety because the company is only making a “copy” of a brand drug.
Finally the FDA has agreed to tackle the issue. While this will not bring relief to the hundreds of victims injured by generic drugs’ dangerous side-effects, it will help make generic drugs safer for all consumers in the future because generic drug makers will now have the responsibility to disclose new safety risks and not rely on the brand maker to do so.
Every corporation should have a responsibility to make sure their product is safe and properly warn about their products’ dangers. Safety should not be a matter of brand or generic.

By |2018-09-03T07:31:58+00:00July 25th, 2018|General|

About the Author: