Not Exactly Spare Change - Assessing FDA in a New Era

It is an understatement to say that there has been a tidal wave of change with the inauguration of a new administration and with incoming changes in agency leadership at FDA. There have been freezes on communications and meetings and hiring. High profile staffers have departed from important roles. Early retirement has been offered for federal employees. Tariffs have been threatened and some put into effect. Court cases seeking to stem the extent of change have been brought with undetermined effects. The result is the potential for impact that is both broad and deep on the way medicines are approved and regulated in the United States. In fact, it is much more than a single blog posting should cover, so here are a few of the key essentials to consider.

1. Approvals - In the near term, the most significant potential impact is on the timing of new approvals, due to multiple factors.

   1. AdComms - Firstly media reports that there one scheduled FDA Advisory Committee meeting has been postponed and another cancelled. No new ones have been announced and in fact, FDA has not published any notice at all in the Federal Register for weeks. Given the scope of change, one could speculate that ultimately the role, function and makeup of advisory committees may be under review with new leadership. That process would likely take time, impacting not only the number of AdComms held in the coming months, but would have a subsequent effect on meeting PDUFA dates (see below) as well as potentially impact the way the meetings are conducted. In other words, relying on past AdComms to help prepare for upcoming AdComms may get complicated.

   2. Staffing - FDA is awaiting not only a new commissioner, but a new head of the Center for Drug Evaluation and Research (CDER). In one interview, the former Commissioner stated that a number of staff were leaving the agency while others were in "wait and see" mode which could mean that there are a number of staff who have departed but are the part of the iceberg below the water line. In addition, there is an offer from the executive branch to federal employees to take early retirement. The fact that there may be fewer staff as well as new staff who may be unaccustomed to their role could result in a potential delays in the consideration and approval of new drugs. In addition to the staffing issues, the incoming HHS Secretary indicated there would be some investigations after his confirmation which could serve as a distraction to the status quo.

   3. PDUFA Dates - It is not known whether or not any potential staffing issues could impact the ability to meet PDUFA dates on a timely basis. But it may be more than staffing that will have an impact. If there is a systemic review of the way that FDA reviews and approves drugs overall, it could slow down the upcoming schedule. So far, the agency has been meeting several dates that had been in place. But this week, one company announced after its PDUFA date had passed that it had received a communication from the agency stating that it would be delayed though there were no outstanding items that needed to be addressed with regard to the application, without further reason being given and apparently without any new date set.

2. Enforcement - In the mid-term, a change in leadership could also bring about new scrutiny on policies related to the role of Direct-to-Consumer (DTC) advertising. The policy debate alone could result in a potential chilling effect on DTC. But moreover it could also jumpstart what has been a very diminished pace of enforcement over the past several years from the Office of Prescription Drug Promotion to put an enhanced spotlight on industry communications while the issue is up for debate.

Meanwhile, FDA communications appears to still be in some degree of stasis, with only two press releases issued since January 17. No new FDA Roundups have come out.

In short, his is only a small part of what could become a developing narrative on how change is impacting FDA. From a review of Accelerated Approval approaches to an examination of the relationship between industry and FDA and how they interact to an altered approach to off-label communications. And much, much more. There is the potential for a good deal of change in the coming weeks and months.