The old saying “March comes in like a lion and goes out like a lamb” might apply to March 2025 as the OGD has issued 34 full-approval actions and 17 tentative-approval actions through March 17th. The biggest day was the first business day of March when the OGD pushed out eleven full- and four tentative-approval actions. A mid-month that starts with a total of 51 approval and tentative-approval actions could lead to a new high thus far in FY 2025—that is, unless the second half of the month becomes more lamblike!
It’s hard to believe that one-third of this fiscal year is almost over. Time really is flying by and the pressure on the OGD is growing as the seemingly everchanging hiring and firing (or downsizing, if you will) of the federal workforce continues at an alarming speed and with highly inconsistent messaging. With new offers of $25,000 cash for employees to leave their positions and the unfolding picture of who is and who is not eligible to take the bounty continues to cloud the CDER (specifically the OGD and OPQ) staffing picture. We have heard that project managers (PMs), apart from Public Health Service Officers, are eligible for this current offer. The potential loss of highly trained PMs raises considerable concern that, while they do not directly review applications at the FDA, they are the “grease for the wheels” of application reviews and are also the main contact points for industry. Without these critical folks, reviewers will have to start taking application status calls, which will take time away from their review activities and, thus, slow the entire operation to perhaps a pre-GDUFA pace. PMs increase the efficiency of reviewers by performing many of the administrative activities that would fall to reviewers without the PMs’ assistance.
While there is no true window (at this time) through which industry and other stakeholders can see how the disruption in process and productivity will manifest itself, the assumptions being made by industry in the midst of this uncertainty are not pretty. Could it be that the OGD will be forced to shut off communications regarding status reports on ANDAs? Will goal dates be missed? How will the new GDUFA negotiations be viewed from the industry’s perspective? Will they be willing to pay more for less? As the expression goes, “May you live in interesting times,” which according to Wikipedia “is an English expression that is claimed to be a translation of a traditional Chinese curse. The expression is ironic: ‘interesting’ times are usually times of trouble.” Let’s hope not, but we won’t know until the dust settles and we see how political actions play out and how those actions impact the drug review and approval process.
