It appears as though some drug labels are missing. I just want to know if I'm missing something obvious?

Specifically I cannot find either Kymriah or Yescarta searching by their brand or generic name. Both drugs were approved in 2017. I have downloaded the complete label dataset from https://download.open.fda.gov/drug/label/drug-label-000X-of-0007.json.zip and confirm that neither terms appear in the complete dataset at all.

Example search: https://api.fda.gov/drug/label.json?api_key=XXXX&search=kymriah

edit: I have confirmed that the kymriah label XML files are present on the SPL S3 bucket:

s3://download.open.fda.gov/data/spl/11dc1c28-0cf5-4290-b499-eb5391a232c2 s3://download.open.fda.gov/data/spl/22dc1c28-0cf5-4290-b499-eb5391a232c2 s3://download.open.fda.gov/data/spl/60770743-9a0b-4793-a4c7-8ebcd2d02080

edit after answer:

To expand Denis Krylov's answer.

The SPL processing pipeline uses SPLDocuments.csv as the master list for drugs to process and import into OpenFDA. The file can be retrieved as follows:

aws s3 cp s3://download.open.fda.gov/data/spl/change_log/SPLDocuments.csv .

If we were to execute:

head SPLDocuments.csv

We would get something like the following:

"Document Id","Document Type","Load Time" 7b8f583f-8df4-4aea-bec8-206598ecfefe,"HUMAN PRESCRIPTION DRUG LABEL",20180402100037 bac17f46-9dfa-4e00-a047-02067e450f84,"Indexing - Substance",20170928145900

The SPL processing pipeline only takes items that contain 'human' in the second column (document type). As of today, there are 18 products which contain "cellular therapy" as the document type. These are currently ignored by openfda, although its not clear if this is by design or not.

  • Yes, this is by design. We'd have to inquiry within the FDA to see if the design can be changed. – Denis Krylov Jul 2 '18 at 18:21

Cell therapy drugs aren't indexed by openFDA. Please see the relevant code here: https://github.com/FDA/openfda/blob/master/openfda/spl/pipeline.py#L90


Please send your inquiry regarding this subject to open@fda.hhs.gov. Thank you.

openFDA team

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