Marketing status notifications: FDA fills in details in final guidance

Regulatory NewsRegulatory News | 10 August 2020 |  By 

The US Food and Drug Administration (FDA) on Monday finalized its guidance on marketing status notifications for new and generic drugs, clarifying its expectations for application holders required to submit marketing status notifications when their products are withdrawn from sale or are not available for sale.
Under the FDA Reauthorization Act of 2017 (FDARA), drugmakers are required to notify FDA regarding the marketing status of their approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) when those products are withdrawn or will not be available for sale.
The final guidance comes a year and a half after the agency issued the draft version for comment and no longer includes a section on the one-time updates required under FDARA, as the due date for the updates has passed and FDA says it has completed its review and updated the Orange Book accordingly. (RELATED: Marketing status notifications: FDA drafts guidance, Regulatory Focus 30 January 2019).
Final guidance
In the final guidance, FDA clarifies that it will use the information available to it, including annual reports, to determine whether a drug is unavailable and notes that, “A drug is considered withdrawn from sale when the application holder ceases its own distribution, even if the application holder eventually plans to return to the market,” except when due to a routine or temporary supply interruption.
When a drug is withdrawn from the market, drugmakers are required to notify FDA 180 days prior to the withdrawal or “as soon as practicable but not later than the date of withdrawal.” FDA clarifies that it anticipates “that it would be practicable for an application holder to notify FDA immediately after it decides to withdraw [a] product from sale.”
FDA also explains that it will notify application holders electronically in a monthly update before moving a product to the discontinued section of the Orange Book in the event the application holder fails to submit a marketing status notification to the agency.
The final guidance addresses questions concerning products marketed under multiple national drug codes (NDCs). FDA says that application holders, “Should only submit notification that the drug product is withdrawn from sale when the application holder has ceased marketing the product under all relevant NDs.” A similar expectation applies to NDA holders that market a branded and authorized generic version of the same drug product.
When determining the date a drug product is expected to no longer be available for sale, FDA says it is reasonable for this date “to be the date on which the application holder will or did cease its own distribution of the drug product,” and notes that application holders should provide an “actual date” to fulfill the notification requirement.
Additionally, FDA says sponsors should provide the last date of manufacturing, the last date of distribution and lot expiration dates, if known, and explains that notifications should not be submitted more than 180 days prior to withdrawing a product from sale.
The final guidance also expands the section on submitting notification when a drug is not available for sale to include examples of reasons that have been provided to the agency so far, including: “A lack of demand; an interruption in the supply of drug product components; or issues related to production for a commercial launch at day 180.”
In cases where an application holder notified FDA that a product would not be available for sale but now intends to market the drug, FDA says the company should notify it 30-60 days before launch and not later than the date it begins marketing the product.


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