For the second time, the Food and Drug Administration has delayed a controversial rule for updating generic drug labeling that would allow generic drug makers to independently update safety warnings, something only brand-name drug makers can currently do before receiving regulatory permission.
In a notice published in the Federal Register, the agency said the rule will be published in July 2016. The FDA originally planned to publish its rule late last year, but then delayed publication until this fall. The delay came amid push-back from the pharmaceutical industry, as well as some congressional lawmakers who questioned whether the agency has the authority to issue such a rule.
The agency first proposed its rule two years ago following a 2011 US Supreme Court decision that federal law does not permit generic drug makers to make changes to their warning labels independently. Consequently, the court ruled that generic drug makers should not be held accountable for a failure to warn against a safety risk.
The decision prompted fierce criticism from consumer groups that said generic labeling does not warn patients sufficiently about the risks of numerous medications. Many patients use generic drugs instead of brand-name medications, and currently about 88 percent of prescriptions filled in the United States are for generics, according to the IMS Institute for Health Informatics, a research firm.
By proposing the rule, FDA said it wants to “create parity” between brand-name and generic drug makers. Since the passage of the 1984 Hatch-Waxman Act, generic drug makers have not been required to run tests to prove their medicines are the same as brand- name drugs and, therefore, have not had to upgrade labels with safety information.
One consumer group is livid over the delay. Public Citizen, which petitioned the FDA to issue a rule, argued the delay creates a “safety gap” for millions of patients and is worried that the agency may be succumbing to industry pressure. Earlier this year, the trade groups for both generic and brand-name drug makers offered their own proposal for labeling changes.
“The agency should resist pressure from the pharmaceutical industry and finalize a rule that will protect patients,” Dr. Michael Carome, who heads the Public Citizen Health Research Group, said in a statement. “The agency should move expeditiously to finalize its proposed rule, which will better protect patients by ensuring they have timely access to updated safety information.”
For its part, brand-name and generic drug makers maintain its suggestions would speed the process by giving the FDA responsibility for making changes. However, the generic trade group has argued the FDA rule could add $4 billion to the nation’s health care bill because regulatory requirements and litigation costs would eventually force manufacturers to raise prices.
We asked the trade groups for the brand-name and generic drug makers for comment and will update you accordingly.