With more power comes more responsibility. And generics makers know it. If the FDA follows through on a new rule allowing them the authority to update their own labels, then they'll be on the hook if they fail to.
Generics makers have successfully argued in court that they're not liable for failing to warn about safety problems that may then injure patients. After all, they aren't allowed to change the FDA-approved labeling on their products. That labeling has to conform to the version approved for their branded counterparts--no exceptions, and no questions asked.
In fact, the U.S. Supreme Court itself validated that argument in a 2011 ruling in the Pliva v. Mensing case. Patient lawsuits over generic drugs aren't valid because of those labeling rules. That's a shield generics makers would like to keep.
Friday, the FDA proposed to change all that. Under a proposal now open for public comment, the agency would allow generics manufacturers to update product labeling independently as new safety information arises--and without prior review by the FDA. It's the same power as that granted to branded drugmakers. The agency said the new power would make sure generics makers have an incentive to adequately monitor the safety of their products--an incentive that's now missing in light of Pliva v. Mensing, The New York Times reports.
After a labeling change under the new regulation, the FDA would review it, decide whether it's justified, and then determine whether the change should be applied to other versions of the same product, branded and otherwise. Generics makers would be required to alert branded companies about their label changes as well.
"This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "More than 80% 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 Generic Pharmaceutical Association (GPhA) has a few objections, however. One, the GPhA questions whether the FDA actually has the authority to change the rules this way. Two, if the rule does change, then won't that create a lot of confusion in the marketplace? "GPhA is very concerned that multiple versions of critical safety information would lead to unnecessary confusion and uncertainty for prescribers and other healthcare professionals, with harmful consequences for patients," GPhA President Ralph Neas said in a statement, adding that the association plans to "address" this concern in its comments to the FDA about the change.
The U.S. Chamber of Commerce went a bit further, adding the explicit warning that the FDA rule change could expose drugmakers to lawsuits and, in turn, push up the costs of prescription drugs by billions of dollars. "The FDA's proposal writes a prescription for mega lawsuits against generic drug makers by plaintiffs' lawyers alleging that generic labels are somehow inadequate," said Lisa Rickard, president of the chamber's Institute for Legal Reform, in a statement.
Consumer advocates, however, have been fighting for this change for awhile--and so they're full of praise for the agency's move. Public Citizen, which petitioned the FDA to change the no-updates rule, said it's "extremely pleased" about the proposal. The group believes patients will benefit from the "added protection" the new rule would provide. "Many potential hazards are not discovered until years after drugs have been on the market," the group said in a statement. "[G]eneric drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk. The new rule should remedy this public health problem."
- see the release from the FDA
- read the Chamber's statement
Special Report: 10 Largest Settlements and Judgments