Don’t Forget Your FDA Valentine

In addition to reauthorizing various user fee programs, the FDA Reauthorization Act of 2017 (FDARA), which was enacted last summer, added a one-time marketing status reporting requirement for holders of new drug applications (NDAs) and holders of abbreviated new drug applications (ANDAs). Specifically, new section 506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 356i) provides, among other things, that all NDA and ANDA holders must submit a one-time report to FDA stating whether the holder’s drugs listed in the active section of the publication, Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) are available for sale. Additionally, approved application holders must provide a list of any NDAs or ANDAs that are currently listed in the active section of the Orange Book that have been withdrawn from sale or have never been available for sale.

The report is due to FDA by Wednesday, February 14, 2018 (180 days after enactment of FDARA). FDA has provided guidance on its website on how to submit the information at OneTimeReport.

AGG Observations 

  • Recently approved drugs that are scheduled to come on the market sometime after February 14th are to be reported as “never been available for sale.” FDA directs sponsors to include the date on which the drug will be made available for sale, however. Presumably, this means that FDA won’t move recently approved applications for drugs not yet on the market to the Orange Book’s Discontinued List provided a scheduled date for availability is included. 
  • FDA also states that sponsors who have multiple approved applications may submit a single listing of all to each of their NDA and ANDA files. A separate notice need not be prepared for submission to each file. Each NDA and ANDA file does need a submission, but “the same report could be submitted to each applicable NDA and ANDA file.”