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Regulatory Focus™ > News Articles > Opponents, Proponents of Generic Drug Labeling Rule Unleash New Arguments and Supporters

Opponents, Proponents of Generic Drug Labeling Rule Unleash New Arguments and Supporters

Posted 06 March 2014 | By Alexander Gaffney, RAC

As legislators prepare to debate the merits of a new proposal by the US Food and Drug Administration (FDA) to change the way generic drug labels are updated to reflect new safety risks, supporters on both sides of the debate are marshalling support for their arguments.


Focus has written extensively about the proposed rule, including its legal background, initial calls by legislators for reform, FDA's early plans for a rule change, the reaction of legal experts to the rule, the reaction of the generic drug industry, FDA's extension of the rule's comment period, the reaction of conservative legislators, the generic drug industry's estimates of the rule's costs, and most recently a proposed House Energy and Commerce Committee hearing on the rule.

In short, FDA's rule would allow generic drug manufacturers to temporarily update the labels on their products if they were made aware of new safety issues that might pose a risk for consumers. Those updates, which would be done through the submission of a Changes Being Effected (CBE) Zero-day (CBE-0) application, would allow the companies to immediately make changes while waiting for FDA and the owner (if they still existed) of the original reference listed drug (RLD) to decide if the change was necessary.

FDA's intent, it said, was to permit differences to exist between the NDA and the ANDA on a "temporary basis."

Against The Rule

As we're written before, the proposed rule has received a massive amount of pushback from members of the pharmaceutical industry, who have argued that the rule is complicated, expensive and in all likelihood illegal.

On 6 March 2013, the generic drug association trade group GPhA unveiled a new coalition comprised of 21 health industry groups opposed to the rule.

While pledging full support for a process that allows generic drug labels to be updated more easily with safety information, the groups contend that the proposed rule as written would have "unintended negative consequences."

"For example, the proposed rule creates the regulatory framework whereby multiple, different labeling, including different warnings, can simultaneously exist in the marketplace for multiple generic versions of a drug," they wrote in a letter to FDA Commissioner Margaret Hamburg. "This would be inconsistent with FDA's longstanding, unwavering emphasis on consistency in drug labeling and potentially confusing for health care professionals."

The groups also cited an earlier report, covered by Focus, that found the rule could cost generic manufacturers as much as $4 billion per year in additional litigation-based costs.

Instead, "simple changes" to the proposed rule would allow FDA to achieve its objectives without imposing the same costs, the letter states, though it does not explain what those "simple changes" are.

For the Rule

But until now, one side has been relatively silent: Those in favor of the rule.

That some legislators supported FDA's plan was known even before the rule existed. In the wake of Mutual v. Bartlett, some legislators had supported legislation that would have required FDA to use the CBE process to allow generic companies to update their labels.

Since the release of the rule, those legislators and other groups who supported the legislation have been relatively quiet.

That silence now seems to be ending. On 5 March 2014, a group of 41 Democratic legislators released the text of a letter they sent to Hamburg expressing their support of the rule. Pledging their "strong support" for the rule, the letter-unusually long by congressional standards-argues that the proposed rule would allow the communication of safety risks more quickly than is currently allowed.

"Often, risks associated with a drug do not become known until after a drug has been on the market for a number of years, including after generic drugs have entered the market and sales of the branded drug have declined," the legislators observed. Given FDA's limited resources to monitor drugs on the market, the input of manufacturers and the CBE process is crucial, they said.

They also noted that in some cases, the generic drug manufacturer is the only manufacturer of the drug left on the market. The current rules do not permit them to update the label unilaterally, they noted.

The legislators also seemed to indicate that opening up generic manufacturers to lawsuits was a feature of the proposed rule, not a flaw. The current disparity of outcomes for consumers injured by generic drugs runs "directly counter to the intent of the Hatch-Waxman Act," they wrote. It is worth noting that Henry Waxman, the retiring author of that bill, is among the signatories to the letter.

The letter also downplays legal concerns about the "sameness" principle under Hatch-Waxman. Legislators wrote that because the change is temporary, the sameness principle would be preserved. The legislators called this an "appropriate balance."

Further, "similar differences in labeling information already occur between the time when a brand name manufacturer submits a CBE Supplement reflecting a labeling change for a specific product, and when the labeling change receives FDA approval and must be implemented by all ANDA-holders for that drug," they argued. In other words, the "sameness" principle already has exemptions.

The legislators' letter was also preceded on 28 February 2014 by Public Citizen, which planned to advocate on the rule's behalf at a House hearing that was ultimately postponed due to inclement weather. In an emailed statement to Focus, Public Citizen mirrored the legislators' arguments, and also cast doubt on a study which found the rule would raise costs for generic manufacturers by $4 billion per year.

"Generic manufactures have argued their cost would be greater if the rule changed, because they would be open to liability for harm to patients if they failed to provide adequate warnings about safety risks associated with their products," they wrote. "However, for all but the last three years, generic manufacturers have faced liability risk; until the U.S. Supreme Court's June 2011 decision in PLIVA v. Mensing, generic companies could be and were sometimes sued for failure to warn of risks posed by their products. So the proposed rule would not create a new cost."


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