Proposed FDA Rule Will Make Generic Drug Makers More Accountable to Consuming Public

What many are calling a “safety loophole” involving generic drugs has consumers concerned, and the FDA proposing regulation changes.

People old and young take prescription drugs to treat chronic disease or acute illness. In fact, 80% of the drugs we take are generic versions of brand name drugs. People frequently choose generic drugs because they are the same chemical composition as brand name drugs, but they cost less and we assume are just as safe.

But what happens when a generic drug is unsafe, and ends up injuring or killing someone? The safety of the drugs we take, and our resulting personal safety, may be unnecessarily threatened because of a loophole in FDA regulations.

Under current FDA rules, only brand-name drug manufacturers are responsible for safety warnings, also called “labeling”.  Brand name drug makers are supposed to monitor their drugs after they go to market, and are required to report adverse reactions and drug safety problems to the FDA.

Brand name drug makers can independently announce revised safety warnings, or labeling changes, without prior FDA approval and must also promptly communicate adverse reactions and safety issues to the public. The glitch in the system arises because generic drug manufacturers cannot communicate revised safety information directly to the public, but must first submit that to the FDA for review and approval.

Under FDA regulations, generic drugs must contain the exact same safety warning provided by the brand name drug manufacturer. If generic drug makers discover safety issues with the drug, they have no independent duty to communicate directly to the public but must first submit safety data to the FDA for review and approval. The time delay can end up costing someone his or her life.

Because they have no control over a drug’s safety warning, and no duty to communicate urgent drug safety warnings the public, generic drug makers also have no legal liability if a drug is unsafe and harms or kills someone.

Consumer watchdog groups are understandably concerned that because they have no legal liability, generic drug makers have no incentive to monitor the safety of their products, or to communicate drug safety problems at all.

Generic drug makers contend that they are concerned with drug safety despite their legal immunity, but that requiring them to provide safety data to brand name manufacturers, and to submit updated drug safety warnings is an unnecessary burden that will only create confusion and drive up the cost of generic drugs.

In an effort to close this dangerous public safety gap, the FDA recently suggested regulation changes in an effort to enhance the communication of generic drug safety issues. The FDA proposes that generic drug makers can and should quickly provide updated drug safety information directly to the consuming public without prior FDA approval, and to share safety data with its brand name counterparts.

The FDA rule would also require brand name manufacturers to be aware of the safety data of generic drug makers when considering their own drug labeling modifications.

Finally, to enhance public awareness, the FDA further announced that it will provide drug safety information updates concerning brand name and generic drugs on its website at

We applaud the FDA’s effort to address this critical drug safety issue. This regulation change will enhance a generic drug makers’ ability to quickly provide consumers with vital generic drug safety information, and is also a legal basis by which generic drug makers will be held legally accountable for the safety of their drugs and that’s a good thing for the consuming public.

Until these new FDA changes are enacted, we recommend talking with your doctor and your pharmacist before taking another generic medication. By not doing so, you may not only endanger your life, but also unknowingly waive your Constitutional right to pursue legal action against a generic drug maker if an unsafe generic drug injures you.

A partner with pharmaceutical liability and personal injury firm Bubalo Law PLC, explained,

“It is absolutely horrifying that generic drug manufacturers have no legal duty and no incentive to provide consumers and their physicians with up-to-date safety information. Equally appalling is that consumers have no recourse against a generic drug maker if they are injured or killed by the drug. If these drug makers are permitted to hide behind this loophole, and we’ve seen that they certainly do, none of us are safe.”