The U.S. Food and Drug Administration is seeking to to end restrictions on labeling revisions by generic drugmakers, a move that consumer advocates say would close a gap that threatens patient health and safety and make companies more accountable.
The FDA spelled out its intent in a posting on the Federal Office of Management and Budget’s web site July 3. The changes would allow generic drugmakers to make changes to drug labels when they become aware of new safety risks related to a product. The agency is also expected to require all manufacturers of the same drug submit conforming labeling revisions after the FDA has approved a revision by one manufacturer of that drug. Currently, generic drugmakers are required by law to carry the same label used on the branded equivalent of a product.
The effort comes two years after the consumer advocacy group Public Citizen petitioned the agency to revise generic drug labeling rules to ensure that drug labels provide adequate warnings to reflect new information that becomes available after a drug is approved for marketing. It also follows the recent U.S. Supreme Court ruling that echoed an earlier decision that insulates generic drugmakers from design defect claims brought under state laws because federal law preempts them.
“Many potential hazards are not discovered until years after drugs have been on the market, as documented in a recent Public Citizen report, yet, currently, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk,” says Sidney Wolfe, founder and senior adviser for Public Citizen’s Health Research Group.
The FDA is expected to have a proposed rule as early as September. “When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs,” says Wolfe.
Nearly 80 percent of prescriptions in the United States are filled with generic drugs. Yet, despite the dominance of generics in the marketplace, said Public Citizen in a June report, the regulatory system has left a potential hazardous gap by not permitting a generic drugmaker to alter a label other than to match a change in the label of a brand-name equivalent. Adding to the problem is the fact that in many cases, brand-name manufacturers stop making their products and leave only generic versions on the market with no one charged with ensuring labeling is adequate, the report noted. It identified 434 drugs on the market with no brand-name equivalents remaining on the market.
Compounding the problem for patients is the insulation from liability the courts have provided generic drugmakers by ruling that federal rules that prevent them from making label changes to their products also preempt state laws. “This release from liability diminishes the incentive to be vigilant about product hazards and eliminates the incentive to request labeling changes in response to new evidence,” the report says.
Bernstein Liebhard, a New York-based law firm that represents plaintiffs in defective drug and device claims, says the planned rule could open the way for victims of generic drug side effects to file product liability lawsuits against generic drug manufacturers.
“This is wonderful news for future victims of generic drug side effects, as the new rule could finally eliminate the current preemption on failure-to-warn claims against generic-drug manufacturers,” the firms says.
The Generic Pharmaceutical Association declined to discuss the changes since the agency has yet to issue a proposal, but said it has a long history of working closely with the FDA to ensuring access to “safe, affordable” generic drugs and will do so on this issue as well.
July 11, 2013