Upcoming US FDA Marketing Status Reporting Deadline for NDA and ANDA Holders

Holders of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) should be aware of an upcoming deadline that requires an affirmative submission from all holders of approved NDAs and ANDAs. Section 804 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA), enacted on August 18, 2017, amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding new section 506I titled "Prompt Reports of Marketing Status". Subsection 506I(c) requires all holders of approved NDAs and ANDAs to review the Food and Drug Administration's (FDA's) Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book) and notify FDA in writing in a "one-time" Marketing Status Report that (i) all of the application holder's drugs in the active section of the Orange Book are available for sale; or (ii) one or more of the application holder's drugs in the active section of the Orange Book have been withdrawn for sale or have never been available sale.

Section 506I(c) requires that NDA and ANDA holders submit the one-time Marketing Status Report within 180 days of August 18, 2017, which is the date on which FDARA was enacted. The 180 day submission deadline falls on Wednesday, February 14, 2018. Thus, all NDA and ANDA holders must submit the required one-time Marketing Status Report by February 14, 2018.Under subsection 506I(d), a failure to submit the one-time Marketing Status Report could result in FDA moving an NDA or ANDA holder's approved drug(s) from the active section of the Orange Book to the discontinued section of the Orange Book.

The procedures for submitting the required one-time report are described on FDA's website on a webpage titled "One-Time Report on Marketing Status Required by FDARA".¹ As explained on that webpage, NDA or ANDA holders can submit the Marketing Status Report to FDA by letter to each applicable NDA or ANDA file (i.e., each NDA or ANDA listed in the active section of the Orange Book that is covered by such one-time report) through the electronic submissions gateway as part of a single grouped submission. The submission should be identified as "MARKETING STATUS REPORT/ONE-TIME UPDATE".

Consistent with what is required under section 506I, the FDA webpage directs approved application holders to indicate in the Marketing Status Report whether all of the NDA or ANDA holder's drugs in the active section of the Orange Book are available for sale, or one or more of the NDA or ANDA holder's drugs in the active section of the Orange Book have been withdrawn from sale or have never been available for sale. If all of the NDA or ANDA holder's drugs in the active section of the Orange Book are available for sale, FDA explains that the application holder should include in the Marketing Status Report letter a statement confirming that the application holder has reviewed the information published in the Orange Book and that all of the application holder's drug products in the active section of the Orange Book are available for sale.

For drugs that have been withdrawn, application holders must include in the Marketing Status Report letter the National Drug Code number for the drug, the identity of the drug (established name, and, if applicable, proprietary name), the NDA or ANDA number, the strength of the drug, the date on which the drug is expected to no longer be available for sale or was no longer available for sale, and the reason for withdrawal of the drug. For drugs that were never marketed, the Marketing Status Report letter must include the identity of the drug, the NDA or ANDA number, the strength of the drug, the date on which the drug will be available for sale (if known), and the reason for not marketing the drug after approval.

In addition to submission of the one-time Marketing Status Report, section 506I also requires holders of approved NDAs and ANDAs to notify FDA in writing 180 days prior to withdrawing an approved drug from sale. If providing notice 180 days prior to withdrawal is "not practicable", the required notification must be made as soon as practicable but no later than the date of withdrawal of the drug. NDA and ANDA holders are also required to notify FDA within 180 calendar days of the date of approval of a drug that will not be available for sale within 180 calendar days of such date of approval. As with failure to submit the required one-time Marketing Status Report, failure to submit timely notice of withdrawal of a drug or notice that a newly approved drug will not be available for sale could result in the drug being moved to the discontinued drug products section of the Orange Book.

If you have any questions regarding these requirements, please do not hesitate to contact us.

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