For the third time, the FDA has delayed a rule requiring generic-drug companies to update product labels if they receive new safety information.
To the dismay of patient advocates and the pleasure of generic-drug makers, the agency is now projecting the final rule won't be published until April 2017. The draft regulations were issued in 2013, and the final rule was widely expected to arrive this spring.
The regulations were crafted in the wake of the Supreme Court's 2011 decision in Pliva v. Mensing. The court ruled that generic-drug companies cannot be held liable for failing to warn patients about the risks of their products because the companies had no control over what the warning labels said.
Unlike brand-name manufacturers, generic-drug makers aren't allowed to make changes to a drug's label without FDA approval unless the maker of the brand-name product does first. Generic-drug makers, meanwhile, would rather wait for the FDA to direct them to change their label.
The FDA said in a statement that projected dates that it provides regarding regulatory schedules aren't definitive and "may be adjusted to reflect ongoing work on specific rules.”
Consumer groups say delaying the rulemaking process puts patients at risk. Michael Carome, director of Public Citizen's Health Research Group, said his organization is now worried about the FDA's commitment to finalizing the rule.
“The FDA is plainly bowing to industry pressure and, in the process, prioritizing industry profits over patient health and safety,” Carome said.
But the Generic Pharmaceutical Association, the industry's trade group, said in a statement that it was pleased with the delay, which “reflects widespread recognition of public health concerns impacting patients and providers.”
“The FDA clearly appreciates the strong concerns articulated by a majority of healthcare experts, particularly those closest to patient prescribing. As drafted, the FDA proposed rule opens the door to avoidable public health risks and carries significant cost consequences that would reverberate through our health system,” GPhA President Chip Davis said in the statement.
Under current rules, a generic drug's label content must be identical to its branded counterpart. Generic-drug makers say the new rule could create the possibility of “different and potentially conflicting” safety information among different generic versions of the same drug and between the generics and their branded counterpart.
A private advisory firm hired by GPhA estimates the rule would increase costs by at least $4 billion a year for patients and payers. GPhA has instead called for an expedited review process.