I remember being locked in for protection at the Parklawn Building at the FDA in the face of protests outside centering on the AIDS crisis and lack of speed in the approval of antivirals as the first time that I felt as though the FDA was really under attack.  Obviously, the FDA came through in the end, and now just think about last time you read an article about AIDS in the U.S. that does anything besides tout the Agency’s accomplishments with respect to speedy approvals of products that keep the virus at such a low level that it cannot be detected in many individuals.

While the FDA has no doubt made some controversial decisions over the years, the FDA is still considered by most to be the gold standard in the world for the approval of safe and effective drug products.  The Agency has clearly butted heads with politicians over the years; however, it has, for the most part, remained an objective arbiter of scientific issues.

This morning, as I did my daily search of news articles for material for blog posts of interest to the industry, it really hit me that the FDA is bracing to face potential political fallout unlike at any other time in history.  Here are just a few of the headlines in today’s trade press:

FDA is still struggling with a lack of Inspectors, but doesn’t have a plan, watchdog finds (by Ed Silverman at STAT) summarizes issues at the FDA, such as staff retention, the backlog of domestic and foreign inspections, and the pressure on inspectors who are away from home 35% to 60% of the time, creating a life-work balance concerns, among other issues that are covered in a recent United States Government Accountability Office (GAO) report here.  (I want to acknowledge that the struggle to maintain a work-life balance and reluctance to travel extensively, as noted above, is not limited or unique to the FDA.)

Trump’s Planned Ramaswamy-Musk Commission Stokes Fears Of Major FDA Cuts (by Jessica Karins, InsideHealthPolicy), raising “concerns about potential rollbacks of rules and major staff cuts at FDA and other health agencies.”

Three Ways Trump Could Disrupt The US FDA (by Michael McCaughan, Pink Sheet, subscription required) asks, “The question is will the FDA be significantly disrupted this time around?”

As a former FDAer, I am sincerely worried for our colleagues at the FDA as no one really knows what is going to happen, but certainly uncertainty is a frightening emotion when your livelihood may be at stake.  Having been a member of the United States Public Health Service for 20+ years, there were various times in the past when it appeared that the administration was planning to do away with the PHS Commissioned Corps, and I can tell you that even the rumor was very unsettling as I worried how I was going to put food on the table if it happened.  In addition to the uncertainty of what will actually happen at the FDA, the pharmaceutical Industry is currently experiencing a series of significant layoffs and contractions that are impacting the pharmaceutical job market.

We do live in uncertain times and with the rhetoric swirling around and directed at the FDA and other health agencies, like “get ready to pack your bags,” I further worry that it will have a negative impact on morale at the Agency and may adversely affect retention of highly qualified FDA staff, leading to a “brain drain.”  However, history also tells us that many dedicated FDA career staffers will remain or try to remain in place as they are highly committed to protecting public health, independent of political pressures.  Hold onto your hats as the rollercoaster ride begins.