Lucas,
A new FDA rule could improve safety for thousands of products.
Manufacturers of generic medications — which account for 84% of all prescriptions — cannot update safety labeling unless specifically instructed to do so by the FDA.
That means the companies can do little to warn physicians and patients when new safety risks come to light.
But in response to pressure from Public Citizen, the FDA is proposing to change its rules to allow manufacturers of generics to update labeling, closing the safety gap.
Add your name if you agree that manufacturers of generics should have the same ability as makers of brand-name versions to update labeling with newly discovered risks.
Hundreds of medications exist only in generic form — meaning that if generic manufacturers are not actively monitoring and proposing safety updates, no producer is.
To improve safety, makers of generics should have the same ability as makers of brand-name versions to revise labeling to include the most current safety information.
Public Citizen has been urging the FDA to make this commonsense reform for years.
We need your help to show support for fixing the problem.
Help us urge the FDA to adopt the new rule.
Although safety risks associated with a particular drug often are not discovered until years after it enters the market, generic manufacturers oppose the proposed rule.
The rule would also correct an absurd inconsistency in how producers of brand-names and generics can be held accountable to patients.
Currently, generic manufacturers generally cannot be held accountable to patients for failing to warn of risks posed by their products. Makers of brand-name versions, on the other hand, can be held accountable.
Patients should not have to trade the right to hold a corporation accountable for access to a generic that may be the only treatment available or affordable.
Join Public Citizen in calling on the FDA to allow manufacturers of generics to revise their labeling to warn patients of safety risks.
Thanks for taking action today.
Onward,
Robert Weissman
President, Public Citizen