May 2, 2022 Labeling

Generics – Labeling content management

While brand name drug refers to the name giving by the producing company, generic drug refers to a drug produced after the active ingredient of the brand name drug. Generic drugs will, however, be sold under different brand names, but will contain the same active ingredients as the brand-name drug.

Generic-drug manufacturers must submit an Abbreviated New Drug Application (ANDA) in order to obtain FDA approval of a generic medication. The ANDA contains information supporting the bioequivalence of a generic drug to the corresponding brand-name medication or reference listed drug (RLD) and ensures that they are the same in regard to active ingredient, dosage form, route of administration, strength, labeling, and indication. In addition, generic-drug manufacturing sites must meet the same requirements for quality and practice as brand-drug manufacturers. Both brand- and generic-drug manufacturers must also conduct post-marketing surveillance, evaluation, and reporting of adverse events to the FDA. However, only brand-drug manufacturers are able to update their drug labeling to reflect newly obtained safety information prior to FDA approval of the change. With a large percentage of dispensed medications being generic and the discontinuation of many brand-name medications following approval of a generic counterpart, the FDA now wants to provide generic-drug manufacturers with the ability to update their product labeling to reflect new safety-related changes even though this will result in temporary differences between the generic and corresponding brand labeling.

Current FDA guidelines require both brand- and generic-drug manufacturers to monitor and review drug safety information and expedite reports of new updates requiring changes to the product labeling. Under these regulations, generic-drug manufacturers may update safety information in their product labeling only after the FDA approves the update for the RLD. Brand-drug manufacturers, however, are authorized to promptly update and communicate new safety information through submission of a changes being effected (CBE-0) supplement to the FDA.

Current Challenges in Generic Label Content Update

1. Different Label Content template – there are no common guidelines for core label, their structure is dependent on the pharmaceutical company’s discretion.

2. Reference Label – Since originators may market their products in multiple countries, it becomes difficult for generic pharmaceutical companies to consider which       national label is available in the public domain to consider for generic label update.

3. Process Variations – The process and conventions for updating the core labels differ between pharmaceutical companies, as no harmonized guideline needs to be       followed and companies also follow their convention when updating the core label.

4. Different Local Label Regulatory Requirements – A comparison of the structure of the EU SmPC and the USPI demonstrates the complexity involved in                  uniting information derived from two major markets and represent overall safety and efficacy information.

5. Company Position on Core Safety and Compliance – The basic goal of continuous label maintenance is to make sure that the product updates will swiftly   reach end users for better decision making on product use. However, safety data management and management of reference safety information is a common area of non-compliance for many companies.

The challenges in the field of core safety maintenance process for generic medicines are complex and an end-to-end solution covering all aspects is the need of hour. The creation of data exchange platforms creates a widely accepted solution to address challenges in core safety maintenance and to create high-quality documents across the industry that improves patient health.

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