Generic Drug Manufacturers Oppose FDA Label Proposal

Generic Drug Manufacturers Oppose FDA Label Proposal

The FDA has proposed label changes that would require generic drug manufacturers to update warning labels when new safety concerns come to light, even if those label changes have not first been made by the original manufacturer of the medication.

The Generic Pharmaceutical Association, a trade group representing generic drug manufacturers, claims the proposed changes would raise the cost of medication and expose off-brand producers to more dangerous medication lawsuits. The FDA claims these changes would create parity by placing equal responsibility on all manufacturers of a medication.

Not Actively Monitoring Safety Concerns

Supporters of the proposed change cite that there is no longer a brand equivalent for approximately 45 percent of the medications currently on the market. Because generic manufacturers are not required to actively monitor safety concerns, that means that around 45 percent of the drugs available today may pose much larger risks than the manufacturers are telling consumers about.

However, because generic manufacturers are not required to update safety information unless it has first been done so by the original manufacturer, victims of these medications are often unable to collect damages following injury. New regulations would make these manufacturers responsible for misleading consumers or failing to provide full information about all of a medication’s potential side-effects.

If you have been injured by a dangerous medication, please contact The Yost Legal Group to schedule a free consultation with one of our Baltimore defective drug attorneys.