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June 19, 2014

Senate Should Resist Calls to Block FDA Rulemaking on Generic Drug Labels

Proposed Rule Is Low-Cost and Critical to Patient Safety

WASHINGTON, D.C. – As Congress considers fiscal year 2015 funding for the U.S. Department of Agriculture, U.S. Food and Drug Administration (FDA) and other agencies, it should avoid taking any actions that could inhibit the FDA from finalizing an important regulation that will promote drug safety, Public Citizen said today.

The proposed regulation would give generic drug manufacturers the option to update labeling to provide warnings about newly discovered risks to patient safety without obtaining advanced approval from the FDA, much as brand-name manufacturers have been able to do for nearly 30 years. Despite the proposed regulation’s strong safety benefits, the House Appropriations Committee recently issued a report on the appropriations bill that criticizes the rulemaking.

The FDA’s proposed regulation, which was issued in response to a Public Citizen petition, reflects the reality that information about serious risks often comes to light after generic versions of a drug are on the market. Generic manufacturers are not permitted under current rules to update warnings to reflect new safety information without awaiting FDA approval.

By contrast, under a longstanding FDA rule, brand-name manufacturers are permitted to make safety updates without prior FDA approval. Although that rule is intended to ensure that updated warnings reach the public as soon as possible, brand-name manufacturers lack incentives to update their labeling after generic versions of a drug are widely available. Further, brand-name manufacturers often cease making a drug for which there is a generic version and, at that point, are not monitoring the product or considering labeling updates.

Meanwhile, generic manufacturers, which continue to market the drug and have access to current information about adverse reactions, are unable to make timely updates to provide new warnings. The FDA’s proposed rule will promote patient safety by eliminating that restriction.

“Criticisms of the proposed regulation in the House Appropriations Committee report are uninformed and evince fundamental misunderstandings of the facts,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The Senate should reject those criticisms.”

Specifically, the House committee report’s criticisms of the FDA’s well-crafted proposal to remedy the disparities created by the existing rules miss the mark in the following ways:

  • The House committee states that it is unaware of a need to change the existing regulation. Public Citizen’s June 2013 report on generic drug labeling and the FDA’s notice of proposed rulemaking provide abundant information on dangers posed by inadequate generic drug labeling, which this proposed rule would address.
  • The House committee suggests that the proposed rule will promote a lack of uniformity between labels for the same drug. But the existing rules already allow for differences among labels, especially when a brand-name manufacturer changes a label unilaterally while the generic manufacturer may not do so. The FDA’s proposed rule will, if anything, reduce the time when there may be material differences among labels.
  • The committee urges that the FDA maintain a system where labels are grounded in scientific evidence. The proposed rule will do so. The rule will allow generic manufacturers to update labeling based on the best evidence available and will continue to require that changes ultimately be approved by the FDA – just as FDA regulations have long allowed brand-name manufacturers to do.
  • The committee expresses concerns about the costs of the rule. But the rule is likely to lower overall health care costs by reducing avoidable injuries to patients. The industry study predicting excessive costs to manufacturers has been criticized for making unsupported assumptions. And concerns that generic manufacturers will face liability costs if they are able to warn consumers and fail to do so overlook that generic manufacturers were already exposed to liability for failure to warn until a 2011 U.S. Supreme Court decision, with no apparent adverse effects on the growth of the industry or the willingness of manufacturers to make generic versions of drugs available.

The benefits of the proposed rule, and the lack of factual support for criticisms of it, are fully explained in Public Citizen’s petition for rulemaking, which led to the proposal; Public Citizen’s comments in support of the proposed rule; and the organization’s testimony supporting it.

“Congress should allow the rulemaking to proceed without interference to enhance patient safety and promote a more rational system of prescription drug regulation,” said Allison Zieve, director of the Public Citizen Litigation Group.

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