How Does The FDA Review Proposed Drug Names?

162017_132140396847214_292624_nThe FDA’s Center for Drug Evaluation and Research (“CDER”) has received about 126,000 reports of medication errors from 2000 to 2009. Some of the medication errors were due to similarly sounding drugs or similarly appearing drug names. The CDER evaluates the potential for a proposed brand name (proprietary name) to cause or contribute to medication errors. CDER’s Division of Medication Error Prevention and Analysis (“DMEPA”) completes over 500 brand name reviews each year.

The FDA recognizes that “…. healthcare practitioners rely on a product’s name as a critical identifier of the appropriate therapy in a market of thousands of products. Therefore, product names that look or sound-alike can lead to medication errors and, potentially, to patient harm by increasing the risk of a healthcare practitioner’s misprescribing or misinterpreting the correct product name, dispensing and/or administering the wrong product, or dispensing it incorrectly.”

During the CDER’s review of proprietary drug names, consideration is given to both the safety and the promotional aspects of a name. If the CDER determines that a proposed name is promotional or may be a source of medication error, the proposed name is rejected.

The CDER’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) evaluates proposed brand names to determine if they are overly fanciful so as to misleadingly imply unique effectiveness or composition, and the DDMAC assesses whether the proposed brand names contribute to overstatement of product efficacy, minimization of risk, broadening of product indications, or making of unsubstantiated superiority claims.

The CDER’s Division of Medication Error Prevention and Analysis (“DMEPA”) performs a safety review of a proprietary (brand) name that involves generating a list of names that could be confused with the proposed proprietary name as well as testing the likelihood of confusion between these names and the proposed proprietary name. DMEPA considers the spelling of the name, pronunciation of the name when spoken, and the appearance of the name when scripted throughout the medication use system (prescribing, dispensing, and administering).

The spelling of the proposed proprietary name is compared with the proprietary and established names of existing and proposed drug products because similarly spelled names may have greater likelihood to sound similar to one another when spoken, or look similar to one another when scripted. DMEPA also considers the hand-written appearance of the proposed name using a number of different legible handwriting samples to address product name confusion that often leads to medication errors. The pronunciation of the proposed proprietary name is also compared with the pronunciation of other product names that may lead to medication mistakes.

The CDER does not review established drug names (non-brand names or generic drug names) – the United States Adopted Names Council (“USANC”) selects a United States Adopted Name (“USAN”) for the drugs marketed in the U.S.  Established names have a common simple word element (called a “stem”) incorporated in the names of all members of a group of related drugs (brand names do not).


For much more detailed information regarding the FDA’s CDER and the Office of Surveillance and Epidemiology (“OSE”) — what they do and how they do it — click here.

If you or a loved one have been injured as a result of a drug error or drug mistake in the United States, you should promptly consult with a medical malpractice lawyer (drug claim lawyer) in your state who may investigate your drug claim for you and represent you in a medication malpractice case, if appropriate.

Click here to visit our website or telephone us toll-free at 800-295-3959 to be connected with drug claim lawyers in your state who may assist you with your medication error claim.

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This entry was posted on Tuesday, November 5th, 2013 at 9:35 am. Both comments and pings are currently closed.


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