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Proposed Labeling Rule Has Serious Implications for Generics Industry

The FDA has recently proposed new labeling requirements for generic pharmaceutical companies. Current regulations do not allow generics companies to independently modify product labeling information; they can only update safety information that has already been submitted by their brand counterpart, and approved by the FDA. This uniformity ensures a consistent process for initiating and applying label updates.

The proposed rule will allow generics manufacturers to temporarily update product labels while FDA approval is pending, effectively creating multiple versions of critical safety information between generics and branded drugs. If the proposed rule goes into effect, the changes will likely lead to confusion for both patients and prescribers. To mitigate the confusion, the FDA’s proposal states that labeling differences would be “managed via a website that would place all updates for a given drug in one place.” Even so, assuming that patients and prescribers will habitually, or even periodically, check the website for updates is questionable.

The Supreme Court has repeatedly upheld the ruling that generic pharmaceutical manufacturers must duplicate the language of branded product labels, and cannot make independent changes to a label without FDA approval. This has historically limited the authority – and the liability – of generics manufacturers. The rule will not only increase accountability, it will add a layer of complexity and cost to companies that typically aim for low overhead, and subsequently lower product costs for consumers. Unfortunately, the proposed FDA website won’t address the monitoring, workflow, and system integration adjustments that may be necessary in order for generics companies to comply. Implementing processes and systems to manage an approved label change is quite different from researching and initiating label changes. The latter is much more complex, especially for companies that market and distribute their products globally.

The proposed rule is open for public comment for approximately 60 days. Both the FDA and the generics industry have the opportunity, and the responsibility, to make sure that the business and cost implications are recognized and understood. Ultimately, underestimating the impact of the proposed regulation could have significant consequences for patients, prescribers, and generics manufacturers.

Tags: Strategy & Compliance