We have posted several blogs about the uncertainty regarding how the FDA staff cuts could impact business as usual with the FDA (see posts here, here, and here).  Kurt Karst, Director at Hyman, Phelps & McNamara, posted a blog today (here) that dives into the “eradication” of the Division of Policy Development in the Office of Generic Drug Policy (OGDP) in the Office of Generic Drugs (OGD).  In his blog, Kurt writes that “there’s a lot that happens before FDA can take action on an ANDA.  And DPD [Division of Policy Development] was a significant piece of that puzzle.”

The DPD was one of three Divisions that fell under the OGDP and many of the things that this Division did to support the scientific, legal, regulatory, and statutory obligations of the Generic Drug Program are outlined in his post.  Kurt details the impact that the DPD had in the assurance of propriety of the OGD’s actions for consistency and policy considerations.  His post goes into detail on many of the following responsibilities of the DPD as well as the significance of how each of these functions contributed to the smooth functioning of the OGD.  Some of the functions identified include:

  • Facilitating the development, clearance, and publication of Product-Specific Guidances (PSGs)
  • Leading the FDA’s implementation of the Drug Competition Action Plan (DCAP)
  • Publishing virtually every GDUFA guidance and MAPP since 2014 in order to fulfill the FDA’s GDUFA commitments
  • Processing voluntary ANDA withdrawals under 21 C.F.R. § 314.150(c)
  • Managing the process of issuing Covered Product Authorizations (CPAs) under the CREATES Act
  • Leading the FDA’s policy implementation of the MODERN Labeling Act, the statutory authority allowing the FDA to make certain generic drug labeling updates
  • Overseeing the development, clearance, and issuance of every policy document that the FDA issued on generic drugs

His post is definitely worth a read.  Thanks to Kurt for his succinct description of the functions and the importance of this Division’s work in the ANDA review and approval process.  Kurt notes, “How these functions critical to the development and approval of generic drugs will now be handled (and by whom) is unclear.”  This weighs on the mind of all of us in the generic industry.