The Drug Price Competition and Patent Term Restoration Act of 1984 requires the FDA to publish a notice of all approved products and their marketing status. The FDA satisfies this requirement by publication of the drug products in the Orange Book; the FDA will publish information in the active section (if the product is currently being marketed) or the discontinued section (if it not being marketed for other than safety or efficacy reasons).
“The FDA Reauthorization Act of 2017 (FDARA) added Section 506I to the FD&C Act, which imposes additional marketing status reporting requirements as follows:
- Notification of withdrawal from sale— requires NDA and ANDA holders to provide a written notification to the FDA 180 days prior to withdrawing an approved drug from sale
- Notification of drug not available for sale— requires NDA and ANDA holders to provide a written notification to the FDA within 180 days of the date of approval of a drug if that drug will not be available for sale within 180 days of the date of approval
- One-time report on marketing status — required NDA and ANDA holders to provide a written notification to the FDA within 180 days of enactment of FDARA stating whether the NDA and ANDA holder’s drug(s) in the active section of the Orange Book were available for sale or whether one or more of the NDA or ANDA holder’s drugs in the active section had been withdrawn from sale or had never been available for sale.”
The draft guidance (here) provides applicants direction on when, how, and what information needs to be provided to the Agency. Applicants should be aware of the timelines necessary for these notices to ensure that they are in compliance with the statute and regulations.