The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

The FDA Reduction-in-Force (Termination)—or “RIF(T)”—announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIF’d.  As the dust begins to settle and we all assess what this means for the future of FDA and the public health, generally, this blogger wanted to call out one particular division in the Office of Generic Drugs (OGD), funded by user fees under the Generic Drug User Fee Amendments (GDUFA), that was eradicated and what that might mean for the immediate future of generic drugs in America: the Division of Policy Development in the Office of Generic Drug Policy (OGDP), which was created in late 2013/early 2014 in part to implement the first iteration of GDUFA.

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD).  As folks steeped in the world of generic drugs and Hatch-Waxman know, there’s a lot that happens before FDA can take action on an ANDA.  And DPD was a significant piece of that puzzle.

Among other things, DPD’s functions included:

• Facilitating the development, clearance, and publication of Product-Specific Guidances (PSGs). This included ensuring FDA consensus on the recommendations in the PSGs and working with the Office of the Commissioner to ensure their timely publication, either in “quarterly batches” of PSGs or as a “stand-alone” PSG when ANDA bioequivalence recommendations may be the subject of a pending Citizen Petition.  Indeed, since 2014, DPD facilitated the publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents (g., the ICH M13A batch), totaling more than 3,000 PSGs (including PSG revisions).  About one third of these PSGs are for complex products and many reflect what OGD and DPD learned about the science of equivalence from GDUFA-funded regulatory science research.
• Leading FDA’s implementation of the Drug Competition Action Plan (DCAP). The DCAP was an initiative launched in 2017 to remove barriers to generic drug development, approval, and market entry (see our previous post here).  Under DCAP, DPD published dozens of guidance documents and Manual of Policies and Procedures (MAPPs), and completed many other initiatives in support of increased drug competition (g., facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List).

• Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDA’s GDUFA commitments. Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.  DPD met all of the GDUFA commitments to publish policy documents (Section IX of the GDUFA III Commitment Letter) and published many others the Division determined would provide clarity to the generic drug industry.

• Processing voluntary ANDA withdrawals under 21 C.F.R. § 314.150(c). These Federal Register notices help generic drug sponsors clean up their ANDA portfolios and sometimes lower their GDUFA program fees.  Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers.

• Managing the process of issuing Covered Product Authorizations (CPAs) under the CREATES Act. This facilitated generic manufacturer’s access to samples of brand-name drugs not readily available through normal market channels for generic drug development.  Since the inception of the program, DPD reportedly met every GDUFA goal date for timely issuance of a CPA.

• Leading FDA’s policy implementation of the MODERN Labeling Act, the statutory authority allowing FDA to make certain generic drug labeling updates.

• Providing significant policy support to the annual update of the Orange Book Preface.

• Overseeing the development, clearance, and issuance of every policy document FDA issued on generic drugs. And, as you can see from FDA’s 2025 CDER Guidance Agenda, DPD was working on guidance documents from 180-day generic drug exclusivity, 3-year exclusivity, 30-month stays, pediatric exclusivity, comparative analyses for drug-device combination products, and many other guidance documents on generic drug “sameness” (including, we understand, a  revised version of the May 2021 guidance, titled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin” that  would have provided scientific and regulatory clarity for the development of ANDAs for generic versions of brand-name GLP-1 drugs.)

DPD also did quite a bit of additional behind-the-scenes work to support and facilitate ANDAs and OGD generally.  For example, DPD worked with subject matter experts from across FDA to clarify the scientific and regulatory pathway for the transition of generic metered-dose inhalers to different propellants, and presented publicly on this topic in December 2024.  But that’s all in the past now.  How these functions critical to the development and approval of generic drugs will now be handled (and by whom) is unclear.  But what seems quite clear is this: generic drug access, availability, and affordability will suffer without DPD.  We can only hope that the powers that be will promptly reconsider this move.