WELCOME TO MEDSHADOW. WE'VE UPDATED OUR LOOK!

FDA Again Delays Rule on New Safety Warnings for Generic Labels

drugs past their expiration date? Clean your medicine cabinet

In a blow to patient safety, the FDA has yet again delayed issuing a rule that would allow generic drugmakers to update the labeling of medications on their own to reflect new safety warnings. This is the third time the agency has punted since it first proposed the rule back in 2013.

The FDA is now eyeing a release in April 2017, according to a notice posted by the White House Office of Information and Regulatory Affairs.

The rule would mark a significant change in how labeling changes for generic drugs are made since currently, such changes can only be made first by the brand drugmaker that originally developed and sold the drug. The brand pharmaceutical company is obligated to make such changes when new information about a medication’s safety comes to light.

The FDA’s proposed rule follows a 2011 Supreme Court decision that found generic manufacturers could not be held liable for failing to inform consumers about risks associated with their drugs since they had no control over any changes on the products’ labeling.

Not surprisingly, the generics industry lobbying group, the Generic Pharmaceutical Association (GPhA), has not been a fan of the proposed rule. After all, it could leave their member companies open to lawsuits. In addition, they say the rule as written could create problems as potentially, the same drug could carry different warnings on its label depending on if it is the brand or generic version.

Instead, GPhA and the Pharmaceutical Research and Manufacturers of America (PhRMA), the brand drug industry trade group, concocted an alternative plan in late 2014. Their proposal would make the FDA responsible for making labeling changes for both brand and generic versions of a drug since, the groups argue, they possess all the clinical trial data on products, as well as adverse event reports.

However, consumer groups have mostly shunned this idea as they fear with the sparse resources the FDA is operating under, they wouldn’t be able to make changes in a timely fashion.

DISCLAIMER: MedShadow provides information and resources related to medications, their effects, and potential side effects. However, it is important to note that we are not a substitute for professional medical advice, diagnosis, or treatment. The content on our site is intended for educational and informational purposes only. Individuals dealing with medical conditions or symptoms should seek guidance from a licensed healthcare professional, such as a physician or pharmacist, who can provide personalized medical advice tailored to their specific circumstances.

While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual's medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.

Was This Article Helpful?

Show Comments (0)
0 0 votes
Article Rating
Subscribe
Notify of
guest
0 Comments
Inline Feedbacks
View all comments
0
Would love your thoughts, please comment.x