The US Food and Drug Administration (FDA) has stated it plans to permit generic drug companies to update the safety information on their products independently.
The new rule would also mean that all manufacturers of the same drug would have to change their warning labels if the FDA approved safety changes for one manufacturer.
The FDA is planning to publish further details about its proposal in September, after which it will be open for public comment.
Currently, generic companies are not allowed to make additions to their safety labels without FDA orders or unless a brand-name manufacturer has already done so.
Brand-name drug companies can update their safety information without FDA approval if they discover a new potential issue.
This new rule would make generic and brand-name drugmakers equal when it came to updating warning labels.
In an online statement Public Citizen’s Health Research Group founder and senior adviser Dr Sidney Wolfe said: "We are extremely pleased to see that the Food and Drug Administration (FDA) today announced its plan to issue a proposed rule to revise FDA regulations about prescription drug labeling.
"When finalised, the revisions will fill a regulatory gap that poses a risk to patient safety."
In 2011 the group submitted a citizen petition to the FDA for them to allow generic companies to address possible dangers they may discover.
In the same year, the US Supreme Court, in a five to four decision, ruled that generic drug makers cannot be sued for not warning patients about side effects as long as they copy the exact safety information listed on the brand-name product.
The Public Citizen’s Health Research Group argued that the public face a possible threat if the generic drug company were to find a potential risk but had to wait for the brand-name drug company to update its information before making changes to its own packaging.
The Generic Pharmaceutical Association has said they believe warning labels should not be the responsibility of individual companies, but the FDA alone.
"Decisions on safety and efficacy of prescription drugs should rest in the hands of the FDA, the only body with the scientific knowledge, regulatory experience and complete data that is needed to make these decisions," Ralph Neas, president of the GPA, told USA Today.
Image: This new rule would make generic and brand-name drugmakers equal when it came to updating warning labels. Photo: courtesy of Mateusz Atroszko.
