March 18, 2014
FRANKFORT – Attorney General Jack Conway, along with 29 other state and territorial attorneys general, sent a letter last week to the U.S. Food and Drug Administration (FDA) supporting a proposed rule that calls for an update to generic drug labeling requirements. The proposed rule would allow generic drug manufacturers to independently update their safety labeling information as soon as they become aware of a new safety risk. General Conway co-sponsored the letter with Indiana Attorney General Greg Zoeller.
“The FDA’s proposed rule would allow a generic drug company to update its drug label using the same process that brand name drug companies currently use,” General Conway said. “As a result, the proposed rule would greatly improve medication safety by ensuring that generic pharmaceutical companies are more closely monitoring their products and diligently alerting their consumers of any new health risks associated with those products.”
Under current regulation, generic drug makers are prohibited from updating safety information on their labels without such changes first being made by the product’s original developer. In their letter, the bipartisan coalition of attorneys general wrote that all consumers deserve adequate drug safety label warnings, especially when the risks are known.
“The proposed rule enables generic drug manufacturers to utilize an already known process; minimizing their learning curve and also allowing them to initiate safety labeling changes that improve public health, ensuring consumers remain appropriately informed of their products’ risks and benefits,” the letter states.
Additionally, the FDA’s proposed rule would protect state generic substitution laws, and it would prevent medical costs from shifting to state tax payers by allowing consumers to take legal action if they are injured by taking a generic drug. Following a 2011 U.S. Supreme Court decision, consumers currently cannot hold generic manufacturers accountable in court if they are harmed by a generic drug. As a result, consumers increasingly turn to Medicaid to fund their necessary health care expenses.
Attorneys general across the country have a vested interest in protecting the health and well-being of their citizens and ensuring that state taxpayers are not forced to bear the burden of medical costs caused by defective generic drugs through the funding of state-based health programs.