FDA to speed safety info on generic drugs

The Food and Drug Administration (FDA) wants to cut down the time it takes patients and doctors to get new safety information about generic drugs.

The FDA’s draft regulation, unveiled on Friday, would address a discrepancy in drug labeling rules that lawmakers and safety advocates have warned could be putting patients at risk.


Under the agency’s proposed regulation, generic pharmaceutical manufacturers would be able to update safety labels on their own, without FDA review.

Currently, they need to wait until the corresponding brand name drug gets approval first. Brand name drugs, however, can update their labels on their own, and get FDA approval after the changes are already made. 

“This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use,” Janet Woodcock, director of the FDA’s drug evaluation and research center, said in a statement. “More than 80 percent of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date.”

The current process has led to delays in updating the safety labels, which consumer advocates say has forced patients to rely on outdated safety labels. Many potential drug hazards aren’t discovered until years after the drugs are released.

The current rules have also been problematic for generic drugs for which the brand name counterpart no longer exists. There are at least 434 such drugs, according to a June study from the consumer interest group Public Citizen. 

In a statement on Friday, Allison Zieve, the head of Public Citizen's litigation group, and Sidney Wolfe, the founder of its health research group, said that the proposal would close a “regulatory gap that poses a risk to patient safety.”

“When finalized after public comments, the rule will provide added protection to the tens of millions of people who regularly use generic drugs,” they added.

Under the new draft regulation, generic drug makers would have to let the brand name manufacturer know when they change their safety labels. Those changes will also be posted on an FDA website.

“Faster safety updates and easier access to this information should be a win–win for all involved,” Woodcock added in a blog post on Friday. 

The U.S. Chamber of Commerce denounced the proposed policy change.

Lisa Rickard, the head of the business lobby’s Institute for Legal Reform said that the proposal could confuse patients, expose drug companies to lawsuits and lead to higher prescription drug costs.   

“It is unfortunate that the FDA is considering a change that could drive up the cost of generic drugs, perhaps by billions of dollars,” she said in a statement.

-- This story was updated at 3:36 p.m.