DISPATCHES FROM AAPS 2006

Excipient database: all systems go as US FDA clears backlog

By Dan Stanton contact

- Last updated on GMT

Image: iStock/maxkabakov
Image: iStock/maxkabakov

Related tags: Pharmacology

The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy.

The IID​ is intended to be a definitive searchable catalogue of every excipient that has ever been used in a US Food and Drug Administration (FDA) approved drug. The database can be cited by drugmakers to help reduce the length of review for a new product which contains a catalogued excipient.

But from around 2005, FDA resource constraints meant that the IID was not being updated with new excipient listings, potentially extending review times or even leading to applications being refused. This has led to criticism from industry such as IPEC.

The Agency began addressing an accumulation of around 4,000 absent formulations towards the end of 2014, and during the AAPS meeting in Denver, Colorado it said the backlog is now practically eliminated.

“IID improvements over the past year have included having staff dedicated to chipping away [at the backlog of 4,000 formulations] and they are almost done,”​ said Susan Zuk, acting branch chief of the Regulations, Guidance and Standards Division within the FDA’s Office of Pharmaceutical Quality.

She added the extra staff had also corrected numerous errors and addressed standardisation in potency measurements across different dosage forms - a task involving sifting through historic NDAs and ANDAs - within the database.

Crowdsourcing quality

Zuk said the FDA is encouraging industry to help monitor the IDD and contact the Agency by email with comments and corrections.

“Our IID mailbox is an enormous help in making corrections. It went live in September 2015 and we had an awful lot of mail from industry informing us on inaccuracies or asking questions about specific entries.”

She described the dialogue as “crowdsourcing quality”​ for the database, with companies correcting excipient naming and potency errors, and adding missing ingredients. The process also helps the FDA understands industry’s needs going forward, she added.

“We encourage you to write to us – you can help to make the system better!”

And if you want to contact the FDA regarding the IID, details are below:

-          Corrections and questions about the IID: VVQHcqngr@sqn.uuf.tbv" target="_self">VVQHcqngr@sqn.uuf.tbv

-          Corrections and questions about preferred names: fda-srs@fda.hhs.gov

-           Questions about excipients in development of generic products: TrarevpQehtf@sqn.uuf.tbv" target="_self">TrarevpQehtf@sqn.uuf.tbv

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