Sanofi Raises Public Health Questions on Use of Nonsense Suffixes With New Vaccines

Regulatory NewsRegulatory News
| 04 February 2019 | By Zachary Brennan 

A lot of ink has been spilled on the controversial random suffixes that the US Food and Drug Administration (FDA) is now tagging on the end of the nonproprietary names of biologics and biosimilars.

Back in January 2017, FDA finalized a guidance document spelling out how this four-letter, FDA-designated meaningless suffix would be attached at the end of biologics’ and biosimilars’ nonproprietary names. Later in 2017 and 2018, companies began to realize FDA was only using the suffixes for a select group of biosimilars and a few biologics.

And now Sanofi is joining the chorus against the four-letter suffixes, saying it will not submit suffixes for two of its vaccines and claiming the addition of suffixes to vaccine labels could cause confusion among health care providers and negatively impact public health.

“Part of the problem is that some vaccines will have the random suffixes while others will not,” Sanofi said in a recent comment to FDA. “HCPs [health care providers] have never seen these suffixes on vaccines before, and there will be a lot of questions that arise from HCPs especially if a broad communication and training is not disseminated before this Guidance is implemented. HCPs will wonder if the letters have meaning and try to discern if it relates to some kind of product information or safety information. HCPs will also need to know why some vaccines have these suffixes and some do not until all vaccines on the market are caught up.”

FDA has said it will go back and add the meaningless suffixes to all previously approved biologics (all biosimilars currently have suffixes), though the agency has yet to begin this process.

Sanofi also points to the approval of two vaccines since the issuance of the guidance that did not include any suffixes -- GlaxoSmithKline’s Shingrix and Dynavax’s Heplisav-B.

“We were wondering what objective criteria was used by the Agency as the Guidance does not seem to allow such exceptions on the part of CBER,” Sanofi said.

Also, the company notes that there is limited space on a vaccine carton and that the addition of four letters may make all the lettering on the package smaller, “making vaccine labels less readable and less user-friendly.”

In addition, health care providers have struggled with the rapid adoption of electronic health records (EHRs), Sanofi notes, which track NDC codes, lot numbers and expiration dates. “The suffix designation is not an established EHR criterion that may render the suffix unhelpful.”

What’s more is the company notes that the Office of Management and Budget (OMB) currently reports that FDA's request for approval of an information collection related to the suffix guidance was withdrawn in July 2018.

“We are not aware of any further action on the request, or any publication by FDA of an OMB decision to approve the request. In the absence of OMB approval, and the lack of a pending request for approval, we believe it is not appropriate for sponsors to be submitting proposed suffixes for vaccine product candidates,” Sanofi said, referring to pending requests for proposed four-letter suffixes to be added to the proper names of its dengue and combination pediatric vaccine product candidates.


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