USFDA PUBLISHES GUIDELINES FOR MANUFACTURERS NAMING NEW MEDICINES
February 22, 2021
The US Food and Drug Administration (FDA) has just published new guidelines for manufacturers regarding the choice of names for their medicines. The guide focuses on how the trust and distinction of other existing medication may be transmitted to end-users, that is, to patients.
The new guide starts with the recommendation that manufacturers undertake fundamental research to avoid the mistakes below, which may lead the patient or even the medical professionals to error:
MISTAKES TO BE AVOIDED
1. Obvious similarities in the spelling and pronunciation of proprietary names of third parties;
2. Reference to inert or inactive ingredients;
3. Lack of all the names of the active ingredients;
4. Make owner's names available from the United States Adopted Names (USAN). [The USAN Council is responsible for selecting simple, informative, and unique names for non-proprietary (generic) drugs. The board and the team meet twice a year to discuss pending negotiations, new items of interest, and political issues];
5. Brand extension in one of the following situations: a. The proprietary name "X" is already associated with a marketed product that contains a specific active ingredient or active portion, and the company uses the same proprietary name "X," with or without a modifier, to present a new product that does not contain the same active ingredient or active portion and b. A company uses a part of the brand already associated with a marketed drug (for example, the use of a prefix string shared with a modified suffix letter string, where the prefix letter string evokes the proprietary name already associated with a marketed drug), with or without a modifier, to present a new product that does not contain the same active ingredient or active portion.
6. Reuse of proprietary names that are no longer commercialized; and
7. Use of letters and numbers that cannot be pronounced as a word, appearing in the proprietary name.
The new guide subsequently lists what it identifies as additional good practices for evaluating a proposed proprietary name:
ADDITIONAL GOOD PRACTICES
1. Avoid names that include references to specific product attributes, involving, for example, manufacturing characteristics (e.g., NameLyophilized), dosage form (e.g., Nametabs), and route of administration (e.g., Nameoral);
2. Avoid medical abbreviations, symbols, or dosage designations in the proprietary name;
ADDITIONAL GOOD PRACTICES
3. Avoid using modifiers as components of a proprietary name, such as Name ODT (orally disintegrating tablet), Name XR (extended-release formulation), etc ...;
4. Use of different proprietary names, as an alternative, for drugs with the same active ingredient but different dosage and dosage for other indications;
5. Avoid proprietary names of medicines identical to names of other medications marketed abroad with other active ingredients; and
6. Avoid incorporating the company name in the proprietary name of the medicine, causing confusion over the use of that company's various drugs.
The guide then focuses on the discussion of proprietary names, in whole or in part, that intentionally mislead, such as, for example, a medicine that has the word cure, in its name, when its effect is only palliative. Such non-conformities include confusion caused by the pronunciation of one or more words.
After that, the guide begins to assess the recommended methods for assessing risks arising from medication errors due to the similarity of a proprietary name in relation to other names, suggesting the following:
RISK ASSESSMENT METHODS TO AVOID MEDICATION ERRORS
1. Name simulation studies evaluating the health professional's response to the proposed names;
2. Obtain medication error data for names that are already associated with commercialized drugs;
3. Computational method to identify names with spelling, pronunciation, and phonetic similarities; and
4. Determination of the safety of names with spelling, pronunciation, and phonetic similarities.
Finally, in addition to a glossary, the guide ends with very interesting and useful attachments: (i) Appendix A - Examples of previously used modifiers and their 205 commonly understood meanings, (ii) Appendix B - Methodology of research to conduct a review of inappropriate adoption of trademarks, (iii) Annex C - Considerations on research methodology for conducting name simulation studies, (iv) Annex D - Checklist of highly similar name pairs, (v ) Annex E - Checklist of moderately similar name pairs and (vi) Annex F - Low similarity name pairs.
The US Food and Drug Administration (FDA) has just published new guidelines for manufacturers regarding the choice of names for their medicines. The guide focuses on how the trust and distinction of other existing medication may be transmitted to end-users, that is, to patients.
The new guide starts with the recommendation that manufacturers undertake fundamental research to avoid the mistakes below, which may lead the patient or even the medical professionals to error:
MISTAKES TO BE AVOIDED
1. Obvious similarities in the spelling and pronunciation of proprietary names of third parties;
2. Reference to inert or inactive ingredients;
3. Lack of all the names of the active ingredients;
4. Make owner's names available from the United States Adopted Names (USAN). [The USAN Council is responsible for selecting simple, informative, and unique names for non-proprietary (generic) drugs. The board and the team meet twice a year to discuss pending negotiations, new items of interest, and political issues];
5. Brand extension in one of the following situations: a. The proprietary name "X" is already associated with a marketed product that contains a specific active ingredient or active portion, and the company uses the same proprietary name "X," with or without a modifier, to present a new product that does not contain the same active ingredient or active portion and b. A company uses a part of the brand already associated with a marketed drug (for example, the use of a prefix string shared with a modified suffix letter string, where the prefix letter string evokes the proprietary name already associated with a marketed drug), with or without a modifier, to present a new product that does not contain the same active ingredient or active portion.
6. Reuse of proprietary names that are no longer commercialized; and
7. Use of letters and numbers that cannot be pronounced as a word, appearing in the proprietary name.
The new guide subsequently lists what it identifies as additional good practices for evaluating a proposed proprietary name:
ADDITIONAL GOOD PRACTICES
1. Avoid names that include references to specific product attributes, involving, for example, manufacturing characteristics (e.g., NameLyophilized), dosage form (e.g., Nametabs), and route of administration (e.g., Nameoral);
2. Avoid medical abbreviations, symbols, or dosage designations in the proprietary name;
ADDITIONAL GOOD PRACTICES
3. Avoid using modifiers as components of a proprietary name, such as Name ODT (orally disintegrating tablet), Name XR (extended-release formulation), etc ...;
4. Use of different proprietary names, as an alternative, for drugs with the same active ingredient but different dosage and dosage for other indications;
5. Avoid proprietary names of medicines identical to names of other medications marketed abroad with other active ingredients; and
6. Avoid incorporating the company name in the proprietary name of the medicine, causing confusion over the use of that company's various drugs.
The guide then focuses on the discussion of proprietary names, in whole or in part, that intentionally mislead, such as, for example, a medicine that has the word cure, in its name, when its effect is only palliative. Such non-conformities include confusion caused by the pronunciation of one or more words.
After that, the guide begins to assess the recommended methods for assessing risks arising from medication errors due to the similarity of a proprietary name in relation to other names, suggesting the following:
RISK ASSESSMENT METHODS TO AVOID MEDICATION ERRORS
1. Name simulation studies evaluating the health professional's response to the proposed names;
2. Obtain medication error data for names that are already associated with commercialized drugs;
3. Computational method to identify names with spelling, pronunciation, and phonetic similarities; and
4. Determination of the safety of names with spelling, pronunciation, and phonetic similarities.
Finally, in addition to a glossary, the guide ends with very interesting and useful attachments: (i) Appendix A - Examples of previously used modifiers and their 205 commonly understood meanings, (ii) Appendix B - Methodology of research to conduct a review of inappropriate adoption of trademarks, (iii) Annex C - Considerations on research methodology for conducting name simulation studies, (iv) Annex D - Checklist of highly similar name pairs, (v ) Annex E - Checklist of moderately similar name pairs and (vi) Annex F - Low similarity name pairs.
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Licks Attorneys Compliance’s Blog provides regular and insightful updates about Ethic and Compliance. The posts are authored by Alexandre Dalmasso, our partner. Licks Attorneys is a top tier Brazilian law firm, specialized in Intellectual Property and recognized for its success handling large and strategic projects in the country.
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O blog Licks Attorneys Compliance fornece atualizações regulares e esclarecedoras sobre Ética e Compliance. As postagens são de autoria de Alexandre Dalmasso, sócio do escritório. O Licks Attorneys é um escritório de advocacia brasileiro renomado, especializado em Propriedade Intelectual e reconhecido por seu sucesso em lidar com grandes e estratégicos cases no país.
