FDA Considers Changes to Generic Drug Labeling Regulations
The U.S. Food & Drug Administration (FDA) is considering a proposed rule change that would allow generic drug makers to update their products’ labels whenever new health risks are discovered. According to a report published last month by The New York Times, generic manufacturers are currently not allowed to make such updates unless ordered to do so by the FDA.
Under the current regulations, companies that manufacturer name-brand medications are able to change their labels as they discover new risks. The FDA’s later approval of those changes is what prompts updates to generic labels.
Generic Drug Lawsuits
Consumer advocates have been pushing the FDA to change its generic drug labeling rules since 2011, after the U.S. Supreme Court barred consumers from bringing state law failure-to-warn claims against generic drug manufacturers in a case called Pliva vs. Mensing. The Court’s majority reasoned that such claims were preempted because generic drug makers had no control over their products’ labels.
Because of the Court’s ruling, an individual allegedly injured by Risperdal can pursue state failure-to-warn claims against Johnson & Johnson and its Janssen Pharmaceuticals unit. However, those legal avenues are closed if the identical injury occurred due to generic versions of the medication.
In 2013, the FDA proposed new regulations that would allow generic manufacturers to make changes to their drugs’ labels when they become aware of new information about potential risks associated with their products. But according to The New York Times, the industry is pushing back aggressively against those proposals, and in what the newspaper characterized as an “unusual move,” the FDA re-opened the period for public comments on the matter until April 27th. On March 27th, the agency also convened a public meeting that was attended by both consumers and representatives from the pharmaceutical industry.
Petition Launched Urging FDA to Adopt Proposed Generic Drug Rules
Last month, Take Justice Back, a grassroots campaign launched by the American Association of Justice, posted a petition on Change.org so that consumers can urge the FDA to adopt the proposed rules and ensure generic drug makers can be held accountable. Take Justice Back and its allies argue that legal accountability is a key incentive to ensure drug companies monitor and adequately warn patients about safety risks.
Bernstein Liebhard LLP represents individuals allegedly harmed by Risperdal and other medications, and the Firm supports efforts to protect consumers’ rights and hold the pharmaceutical industry accountable. If you suffered side effects due to a prescription medication, please contact our office today by calling 1-877-779-1414 for a free legal consultation.