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FDA Defends Generic Drug Labeling Plan

Kate Traynor

Lawmakers on April 1 called on the chief of FDA's drugs division to defend a proposalExternal Link that would allow makers of generic drugs to unilaterally update safety information in their products' professional labeling.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told members of the health subcommittee of the House Committee on Energy and Commerce that the agency's proposed rule, issued last November, "would provide generic drug makers with the same opportunity as brand drug makers to update their labels when they have new safety information."

If enacted, she said, the proposed rule would result in improved communication about important drug safety information for prescribers and patients.

Ralph Neas, president of the Generic Pharmaceutical Association (GPhA), countered to the committee that FDA's proposal would instead "create substantial confusion for everyone in the health care system."

That confusion, he said, would result from the coexistence of different safety information in the labeling for the same drugs made by different manufacturers. And Neas predicted that the confusion would be magnified by a flood of new labeling with excessive warnings of little or no clinical relevance.

Neas also said that the rule would lead to lawsuits against makers of generic drugs and substantial increases in the prices of the drugs.

FDA's plan. The proposed rule would allow manufacturers of generic drugs to submit "changes being effected" (CBE) supplements to FDA. With a CBE-0 supplement, a drug maker can update its labeling with important safety information and distribute it on FDA's receipt of the supplement without waiting for the agency to review the material. This is in contrast to a CBE-30 supplement, which requires a 30-day interval from FDA receipt of the proposed supplemental labeling information to distribution of updated labeling by the drug maker.

"This is really a procedural rule that allows a procedure that was always available to innovators to be available to generics," Woodcock explained.

Under current FDA regulations, only manufacturers of innovator, or reference, drugs may submit a CBE-0 supplement. When the maker of a generic drug discovers a safety problem, the company must notify FDA and wait for the agency and the maker of the reference drug to negotiate labeling changes before revising the generic drug's labeling.

FDA has not instituted a timeline for these revisions. Instead, FDA advises generic product makers to revise their labeling "at the very earliest time possible."

The proposed rule would establish a 30-day time frame for manufacturers to change their product labeling after FDA approves the safety changes.

The proposal also describes an FDA-maintained Web-based system for logging and tracking labeling changes related to the CBE-0 supplements that would be accessible to all drug manufacturers and the public.

Safety. Subcommittee Chair Joe Pitts of Pennsylvania predicted that FDA's proposal would result in "mass confusion" and safety problems because multiple versions of labeling for the same drug would be in circulation at the same time. In this scenario, he said, "FDA-approved labeling would become just one in a crowd."

But Woodcock countered that Pitts' description better fits the current situation than the remedies in the proposed rule.

"When FDA makes a label change to the innovator, there will be multiple different versions" of the labeling for the corresponding generics, she said. "Some will change their label to conform very rapidly; others may take a year or so. So that is the current situation."

Woodcock said the proposed Web-based tracking system and 30-day time frame for revising labeling "will result in less differences among brand and generic labels in the future, if this rule were to be made final."

She noted that the issue is timely because more than 80% of all prescription drugs dispensed in the United States are generics. For more than 400 drug products, only generic versions are currently marketed, and FDA expects this number to increase.

Woodcock also clarified that FDA has standards in place to prevent drug manufacturers from creating a "laundry list" of potentially irrelevant warnings in product labeling. She said these standards were adopted as part of the 2006 Physician Labeling Rule, which states that manufacturers cannot put speculative information in their product labeling.

Liability. Woodcock acknowledged that the claim made by Neas about the proposed rule leading to product liability lawsuits against makers of generic drugs is likely true.

A 2011 Supreme Court ruling established that makers of generic drugs cannot be subject to failure-to-warn tort claims related to safety labeling when these manufacturers are unable, per FDA regulation, to unilaterally change their products' labeling. Manufacturers of brand-name drugs, in contrast, are not protected from such lawsuits.

If the CBE-0 supplement process is made available to makers of generic drugs, as proposed by FDA, those manufacturers would no longer be shielded from these liability claims, Neas said.

He cited estimates in a report from Matrix Global Advisors, an economic policy consulting firm, that FDA's proposal would lead to $4 billion in new annual health care costs related to product liability concerns.

Allison Zieve, general counsel for the consumer advocacy group Public Citizen, told the subcommittee members that GPhA's concerns over product liability, rather than patient safety concerns, are the group's "real objection" to FDA's proposed rule.

Zieve said Public Citizen strongly supports FDA's proposal and believes that it will improve patient safety.

ASHP, in written comments on the proposed rule, stated its support for FDA's efforts to speed the inclusion of important new safety information in product labeling.

But ASHP also expressed concerns about FDA's ability to effectively implement the system described in the rule. The comments note that FDA has historically "faced challenges maintaining consistent and current prescription drug labeling" and has not been able to enforce its previous directives regarding labeling consistency.

The comments state that existing inconsistencies in labeling and enforcement shortcomings could be magnified if manufacturers of generic drugs are allowed to independently initiate CBE-0 supplements in the way FDA has proposed.

ASHP urged FDA to update and make better use of the agency's DailyMed drug labeling database and use that as the central portal for all labeling-related information instead of creating a new database system for CBE-0 supplements.

ASHP was also 1 of 21 signatories on a March 6 letter to FDA Commissioner Margaret Hamburg expressing concerns about potential adverse economic and patient safety effects of adopting the proposed rule.

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