The release of CDER’s OPQ 2022 Annual Report is a grand opportunity for an “Agency and industry” calibration to ensure alignment of performance and strategy.  In any journey, it is prudent to check your compass, map, and progress to date to ensure your trip stays on course.  The report efficiently states the strategic priorities, performance to date, and intended direction for 2023.

Industry could be well-served by checking its own strategy against the report and asking itself, “Are we aligned?”  As we all emerge post-COVID, misalignment is a real risk.  A sampling of items that Lachman has reported on during the year and that merit continued focus are:

  • Supply Chain Management
  • Quality Management Maturity

Supply chain weaknesses were evident prior to COVID, but the pandemic was a catalyst for continued failures.  This was well-documented in the FDA report “Drug Shortages: Root Causes and Potential Solutions” (here).  However, there seem to be challenges in implementing the mitigations outlined in this report.  A draft guidance, “Risk Management Plans to Mitigate the Potential for Drug Shortages,” was published in May 2022, but the link to the CARES Act and the material change to the Federal Food, Drug, and Cosmetic Act (FD&C Act) in section 506C(j) seemingly get lost in the attention that this draft guidance demands.  Meanwhile, the FDA actively works to manage and reduce drug shortages on an ongoing basis; however, maturation of this guidance could drastically increase the indicators and signals for proactive interventions.

Quality Management Maturity (QMM) is also increasing in its visibility and progression, as described in the report.  The program is another of the Agency’s mitigation plans for drug-shortage root causes.  The fundamental difference in this program is the new initiative to create incentives for industry.  However, these incentives are not just focused on manufacturing, but also on payers, which is key, especially for the U.S. market.  The program was unanimously endorsed in November (see here).  Questions persist surrounding the concept of “incentives,” but this is an opportune time for industry to take the lead and create the “pull” and demand that could accelerate these activities.