Reps. Schiff, Kuster Introduce the Updated Drug Labeling for Patient Safety Act
Washington, DC — This week, Representatives Adam Schiff (D-Calif.) and Ann McLane Kuster (D-N.H.) introduced the Updated Drug Labeling for Patient Safety Act, which would ensure that patients are made aware of all potential risks and side effects of prescription drugs, including generic drugs.
The bill would direct the FDA to establish a process to allow generic drug manufacturers to update drug labeling to include new or updated safety-related information, and issue and implement a final rule with a process for conforming the labeling of brand name and generic drugs.
“Americans must be able to trust that the information they receive about their medications is accurate and up to date,” said Rep. Schiff. “Unfortunately, right now patients can be misled by outdated safety information on generic drugs – which is the most common type of medication prescribed – because generics have to adopt brand name labeling that isn’t always up to date. The Updated Drug Labeling for Patient Safety Act will protect patients by ensuring they have the latest health safety information on their generic drug labels.”
“Over 80% of prescriptions filled in the United States are for generic medications. Patients deserve the confidence that these lower-cost drugs adhere to the highest safety standards,” said Rep. Kuster. “Currently, generic drug manufacturers must use the same labeling on their products as their brand-name counterparts, even if risks or side effects are discovered years after being on the market. I’m proud to introduce legislation to allow generic manufacturers to quickly update labeling if they discover health risks and reassure patients that their prescriptions are safe.”
The potential risks and side effects of many prescription drugs are not discovered until years after the drugs have been on the market. Current law requires generic drug manufacturers to use the same labeling for their products as their brand name counterparts. The FDA allows brand name drug manufacturers to update their labeling but does not allow generic manufacturers to do so independently.
Four out of five prescriptions in the United States are written for generic drugs, which tend to be cheaper. As a result, brand name drug sales often shrink significantly after generics enter the market, and there is little incentive for brand name manufacturers to update their labels. Many Americans might be taking drugs with outdated safety information, and they have limited legal options if those drugs cause them harm.
The Updated Drug Labeling for Patient Safety Act is endorsed by Public Citizen and the American Association for Justice.
“No drug is safe in all situations; a drug is safe when used in accordance with labeling that accurately reflects known risks,” said Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group. “Allowing generic drug companies to make safety updates to their products labeling, as this bill aims to do, would fill a safety gap and better protect public health.”
“There must be consistent rules for all drug manufacturers when it comes to safety information,” said Linda Lipsen, CEO of the American Association for Justice. “Patients who take generic drugs do not have the most recent safety information, unlike those taking brand name medication. This sets up an unfair system that is harmful to patients.”
The full bill text can be found here.
###