Notice to Certain Orphan-Drug Designation Holders:
The Food and Drug Administration (FDA) publishes the generic name and/or trade name of a drug on our website at www.fda.gov/orphan after we designate a drug as an orphan drug.It has come to our attention that a small subset of drugs that have received orphan designation were published on our public database using a non-informative code.After careful consideration of this matter, we have concluded that the Orphan Drug Act mandates that the FDA identify to the public products that have received orphan-drug designation.We typically provide this required notice by publishing a generic or trade name of an orphan-designated drug.If, as is the case for some products, there is no generic or trade name, publishing a non-informative code does not meet the statutory disclosure requirement because the public would not be able to identify the drug that has received orphan designation. Therefore, for the small subset of drugs that were published on our public database using a non-informative code, we have replaced each such code with an informative identifier.
Below is a copy of the letter that we mailed to all affected sponsors at their last known address.This letter informed sponsors that, on our website, we had removed the non-informative code for their product and replaced it with an informative identifier.We asked that these sponsors notify us within 20 days of the date of the letter if they believed that the identifier that we had chosen did not accurately identify their product.
Despite reasonable efforts, we were unable to notify a small proportion of affected sponsors.It appears that some sponsors may have gone out of business or may have transferred ownership of or beneficial interest in orphan-drug designation without informing FDA.(We remind sponsors of their obligations to notify us of any change in ownership of orphan-drug designation, under 21 CFR 316.27, and to submit brief progress reports to us on an annual basis, under 21 CFR 316.30.)
Through this notice, FDA seeks to inform sponsors whom we have been otherwise unable to notify that, pursuant to the Orphan Drug Act's disclosure requirements, all non-informative codes in our public orphan drug designations database have been replaced with corresponding informative identifiers. If you believe this notice applies to you, please visit our website at www.fda.gov/orphan.Under “Resources for You," click on the “Search for Orphan Drug Designations and Approvals” and enter your product.If you believe that your product’s current identifier does not accurately identify your product to the public, please promptly contact the Office of Orphan Products Development - Jeffrey Fritsch, R.Ph., at 301-796-8682 or Jeff.Fritsch@fda.hhs.gov.
We appreciate your attention to this matter.If you have any questions, please contact Jeffrey Fritsch, R.Ph., using the above contact information.
The Office of Orphan Products Development, FDA