FDA Pulls Generic Drug Labeling Safety Update Rule
FDA says it is withdrawing its 2013 proposed rule on supplemental applications proposing labeling changes for approved drugs and biological products that would have allowed generic drug makers to independently update and distribute new safety information in drug labels. A statement from FDA commissioner Scott Gottlieb and CDER director Janet Woodcock says the agency heard many pro and con stakeholder comments on the proposal, and ultimately decided that the proposed rule’s challenges outweigh its benefits.
As part of the decision to withdraw the rule, FDA says it is “taking important steps to update the labels on certain generic cancer drugs with modern safety and efficacy information. This effort will help make sure that prescribers and patients have the most up-to-date information to guide treatment decisions and will broaden patient access to generic medicines.”
A Federal Register notice says FDA is withdrawing the proposal “in light of concerns expressed by commenters and considerations regarding agency resources. FDA is continuing to consider ways to improve the communication of important, new acquired drug safety information to healthcare providers and the public and to facilitate efforts to keep drug product labeling up to date throughout the product lifecycle.”
The notice says the agency held a 3/27/15 public meeting at which stakeholders had the opportunity to present or comment on the proposed rule or any alternative proposals to improve communication of drug safety information. “Several comments supported finalizing the rule as originally proposed,” FDA says. “Other comments supported the goal of the proposed rule but expressed concern that temporary labeling differences between generic drugs and the corresponding brand drug could complicate healthcare decision making. Comments in support of the proposed rule maintained that it would enhance drug safety by making healthcare practitioners and the public aware of new safety-related information about a drug more quickly….Comments opposed to the proposed rule raised policy, legal, and cost considerations.”
In their statement, Gottlieb and Woodcock said, “We’ve carefully considered all of the feedback we received from the various stakeholders — both in favor of and against the proposed rule. We’ve evaluated whether there are more effective and efficient ways of keeping generic drug labels up-to-date with the latest safety information and helping to ensure that generic companies continue to engage in an appropriate level of post-market safety surveillance. Fundamentally, we believe that the withdrawal of the proposed rule is in the best interest of the public and that other steps we’re pursuing can achieve our goals.”
Commenting on the FDA decision, Washington Legal Foundation (WLF) chief counsel Richard Samp said the “decision to abandon [the] controversial labeling rule is a major victory for American consumers. The rule’s only purpose was to empower the plaintiffs’ bar, and it posed major health and safety risks.” In comments to the agency since 2013, WLF contended that alternative procedures could ensure that new safety information about FDA-approved drugs would reach doctors and consumers more quickly than under the proposed rule. The legal group said the chief result of the FDA proposal would be consumer confusion brought on because different versions of the same drug would hear conflicting safety warnings.