The agency today established a public docket in the Federal Register in response to drugmakers’ fears of rival companies scooping their planned names while their drugs are still in development.
Since 2008, the FDA has judged drug names as part of the drug labelling approval process, and therefore does not finalise this authorisation until the final marketing application is approved.
Until then, proprietary name review “is limited to a tentative acceptance of that name,” said the FDA. “It is possible that a name judged tentatively acceptable may later be found unacceptable for a number of reasons, including, for example, the intervening entry into the US market of another product with a confusingly similar name, changes in the product’s characteristics during review, or new information about the likelihood of error arising from post-marketing data about another product.”
Confidentiality
Drug companies have expressed concern about the uncertainty of the process up until approval of the whole product application, said the FDA, particularly at the possibility their drug names may be rejected if “another drug whose application was pending, but not public, at the same time as their own” is approved in the meantime.
The FDA said it will not disclose confidential data during the review process “but will communicate with the applicant to the extent permitted by law” information about whether a name is already being considered by the FDA after submission by another company.
“In such situations, FDA generally notifies applicants that their proposed proprietary name could result in medication errors due to confusion with another product that is also under review and informs the applicant that acceptability of a proposed proprietary name may be affected by prior approval of the other product.”
The proposed change, allowing reservation of names in advance, is part of several FDA goals which arose from the 2007 reauthorization of the Prescription Drug User Fee Amendments Act (PDUFA IV) aimed at reducing medication error. This is the first time the Agency has agreed to a process and timelines for notifying applicants of the acceptance or rejection of a proposed proprietary name.
The deadline for comments in the Federal Register is October 27, 2014.