AMA - Drug Name Development Timeline and USAN Review Procedure

Drug Name Development Timeline and USAN Review Procedure

Drug studies conducted in vitro and in animal models
Planned trade names may be filed, if known, with the United States Patent and Trademark Office (USPTO) and other trademark offices
Data about the mechanism of action and potential safety problems that could derail marketing are gathered

Firm obtains permission to conduct clinical studies in the United States (US) from the FDA and receives an IND number

Small-scale safety studies conducted in healthy volunteers
Earliest time that US firms may request a United States Adopted Name (USAN), or non-US firms may request an International Nonproprietary Name (INN)

Small-scale efficacy studies in patients
Typical time for US firms to apply for a USAN
Ballots sent to USAN Council (USANC) for review
When firm and USANC reach consensus, USAN Program files to obtain an INN on behalf of the firm
Planned trade names may be filed for review by FDA, along with supporting documentation

Large-scale efficacy and safety studies in humans
Many firms publish results of earlier clinical and preclinical studies and want the USAN at this time
USAN usually adopted and published
Non-US firms with an INN obtain USAN status for this name

Firm requests clearance from the FDA to market the drug
USAN required for packaging and labeling negotiations, promotional materials
USP adds nomenclature information pertaining to dosage forms and delivery methods
Firm receives final approval of trade name from the FDA

USAN required to market the drug in the US
Continued safety data on the drug and names are collected
Changes to generic or trade name require large-scale education of health care professionals, approval from the FDA
USP publishes monographs determining drug standards, titled with the USAN

Firm gathers required supporting information, including documentation of a search to verify proposed names are free of trademark and generic name conflicts
Pharmaceutical manufacturer or sponsor submits a completed application
USAN Program staff verifies chemistry, searches databases for drug information
Staff determines how the drug may be classified using the nomenclature scheme and whether the proposed names appropriately reflect its action
Staff reviews names for conflicts with generic or proprietary names
Staff prepares a ballot with the firm's proposed names and alternative suggestions, if any
Conflicts with generic or trade names are noted for the USANC

USANC members review names and make selections
Scientists and physicians on the USANC represent the American Medical Association (AMA), American Pharmacists Association (APhA), United States Pharmacopeia (USP) and the FDA
Review criteria include absence of conflicts with trade or generic names, appropriate use of the nomenclature scheme, usefulness of the proposed names to the health care providers
Names too similar to existing generic or trade names are rejected
FDA opinion on the proposed name(s) is sought through the FDA representative to the USANC
When consensus is reached, staff forwards the name selection to the firm

Firm reviews the USANC's selection and accepts or rejects it
Suggested name is posted for public comment online
If the firm accepts the name, it proceeds through international review before adoption as a USAN
Firms rejecting a name must supply alternatives and the rationale for rejection, with supporting documentation
Rejection leads to another round of review by USAN Program staff and the USANC

To ensure international harmonization, USAN Program staff requests an INN
The INN Experts review and accept the proposed name, or suggest an alternative
INN review criteria include conflicts with non-US trademarks or generic names, connotations in languages other than English, and comformity to international nomenclature schemes
INN Expert Group comprised of scientists and regulatory experts from around the world

Firm and USANC notified of the INN Expert Group's decision by the USAN Program staff
Firm and USANC may accept or reject the INN Expert Group's alternative suggestions, if any

Occurs after the USANC, firm and INN Experts reach a consensus
Adopted USAN are published online and forwarded to Chemical Abstracts Service (CAS) and the USP
Internationally, names are published twice, as proposed INN and recommended INN