Once again, the US Food and Drug Administration is delaying the debut of a controversial rule for updating generic drug labeling. The rule would allow generic drug makers to independently update safety warnings, something that only brand-name drug makers can currently do before receiving FDA permission.
The agency never set a specific introduction date, but the rule was widely expected to be introduced this spring. But on Wednesday, a notice indicated the publication date was extended until April 2017. In fact, this marks the third time since the FDA proposed its rule in 2013 that the rule has been delayed amid opposition from the pharmaceutical industry and some lawmakers.
The delay comes one month after the House Appropriations Committee proposed a spending bill that would prevent the FDA from using its funding to enact the rule as early as this summer. At the same time, more than a dozen companies and organizations urged the FDA not to proceed over concerns a potpourri of labels would result. Among them were CVS (CVS) and trade groups representing health insurers, pharmacists, and pharmaceutical wholesalers.
To some, this chain of events raises questions about whether the rule will ever, in fact, become reality.
“We’ve always been given reason to think it would happen,” said Allison Zieve, who heads the litigation group at Public Citizen, which had petitioned the FDA to revise its generic labeling rules. “Now, they’re saying they’ll finalize it next April. We interpret that to mean that it’s done. They just keep delaying it.”
We asked the FDA for comment and will update you accordingly. [UPDATE: An FDA spokeswoman told us that the change reflects “ongoing work,” but could not be more specific.]
As we have noted previously, the FDA proposed the rule following a 2011 US Supreme Court decision that federal law does not permit generic drug makers to independently make changes to their product labels and, therefore, the companies should not be held accountable for failing to warn against a safety risk.
But the court ruling sparked an outcry that generic labeling would be insufficient to warn patients about the risks associated with numerous medications. The concern reflects growing use of generics, which now account for an estimated 88 percent of all prescriptions that are filled in the US, according to the IMS Institute for Healthcare Informatics.
When the FDA proposed its rule, agency officials explained they wanted to “create parity” between brand-name and generic drug makers. Since the Hatch-Waxman Act was passed in 1984, generic drug makers have not been required to run tests to prove their medicines are essentially the same as brand-name drugs. And so, these companies do not have to upgrade product labels with new safety data.
For their part, generic drug makers have lobbied hard to thwart the rule.
Their opposition reflects concern that the rule will motivate lawyers to find ways to make the companies appear negligent if they do not move quickly enough to add newly learned safety information to labels. At one point, the Generic Pharmaceutical Association, an industry trade group, underwrote a white paper claiming the cost of added litigation could add $4 billion to the nation’s health care bill.
Early last year, brand-name and generic drug makers made a joint proposal — brand-name manufacturers would remain responsible for updating product labeling when they learn about new risks. But this would only apply when there are no generic versions available. Otherwise, the FDA would be responsible for mandating label changes for all drugs, including generics.
To what extent the FDA considered this proposal was never clear, although consumer advocates expressed concern the agency would not be likely to act quickly enough on new information, given its limited resources.
[UPDATE: The Generic Pharmaceutical Association later sent us this statement: “The FDA clearly appreciates the strong concerns articulated by a majority of health care experts, particularly those closest to patient prescribing,” said Chip Davis, the trade group’s president. “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.”
[UPDATE: We should note the comment period has not been extended until April 2017, as previously indicated].