Updating Generic Drug Labeling in the US: It’s Not As Easy As It Looks

SCRIP Regulatory Affairs
June 2014
Author: Darshan Bhatt, Sciformix Corporation

The large number of blockbuster branded drugs coming off patent has resulted in significant growth and decentralization within the pharmaceutical industry. In response to the resulting economic pressures, the global pharmaceutical industry is focusing on new growth opportunities in emerging markets and moving towards a mixed portfolio of innovative and generic products.

Pharmaceutical product labeling is a highly regulated and complex process that is an integral part of a company’s overall quality system, and is one process which has grown increasingly complex as the industry has grown and decentralized. The product label includes all the vital information related to the specific product; including its name, manufacturer’s name, identification code, lot number, active and inactive ingredients, usage information, safety information, storage conditions, product quantity, indications and an expiration date. A product with a wide geographical footprint requires the labels in each country/region to comply with the requirements of the local regulatory agencies; increasing the risk of having inconsistent information across labels of the same product.

Ensuring labeling processes are standardized and updated in accordance with regulatory updates is a challenge for both generic and innovator drug manufacturers. This issue has been a talking point within regulatory affairs, and was highlighted last November in the proposed rule by the US Food and Drug Administration to allow generic drug manufacturers to update their label independently.

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