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FDA In Brief: FDA Provides Guidances On Proprietary Naming for Drugs, Changes to Naming Analysis Program

December 8, 2020

Media Inquiries

  Jeremy Kahn
  (301) 796-8671

The following quote is attributed to FDA Principal Deputy Commissioner Amy P. Abernethy, M.D.:

“Millions of Americans take multiple medications daily to improve their health and way of life. The safety of these medicines and their safe usage is of the highest priorities for the FDA. It’s essential that consumers, patients, caregivers, physicians, pharmacists and other health care professionals are provided clear and accurate information to ensure these products are prescribed, dispensed and taken as safely and accurately as possible. Proprietary names of drug products are commonly used by physicians and other health care professionals to prescribe or discuss a drug, and for this reason, accurate identification of these products is essential."

"As part of our ongoing efforts to exploring new and updated drug development approaches, today, we’re providing updated information for drug developers through two best practice guidances to help ensure that drug names can be properly distinguished and not confused with drugs whose names could sound and appear to be similar. These documents will assist developers in choosing names that minimize the risk that end users receive the wrong product, which could be harmful to their health. Furthermore, recently we took related steps to modernize the FDA’s Phonetic and Orthographic Computer Analysis (POCA) program, a tech tool that the FDA uses to determine the similarity between two drug names, to address concerns we have received. The modernized version of the POCA application eliminates the complex download processes and ultimately enhance the software experience."

"We are continuously seeking new methods for improving drug development processes and the guidances and updates provided today are vital parts of the FDA’s efforts to protect the American public and ensure the products they take do not cause them harm.”

Additional Information:

  • Today, the U.S. Food and Drug Administration is issuing two guidances on proprietary naming: Best Practices in Developing Proprietary Names for Human Prescription Drug Products, Final Guidance and Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products, Draft Guidance. These documents provide guidance to sponsors on the development of proposed proprietary names. They describe best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. The documents describe the framework the FDA uses in evaluating proposed proprietary names that the sponsors can use, if they choose to, prior to submitting names for the FDA’s review.
  • Relatedly, in September, the agency announced changes to its Phonetic and Orthographic Computer Analysis (POCA) program. POCA is a software tool that uses an advanced algorithm to determine the orthographic and phonetic similarity between two drug names. The program can compare a drug name against multiple drug names found in several different data sources contained in the software. The modernized version of the POCA application, which is cloud-based, provides the public with a search capability similar to the current public version of POCA. This cloud-based version eliminates the complex download processes required in the existing POCA public version of the application. This new system eliminates the need for users to request access to the program and related software from the FDA.
  • The FDA has opened the docket to receive comments on the Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products Draft Guidance. The comment period is open for 60 days after publication .

Related Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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