Coronavirus, Pandemic Preparedness, and Beyond

One of the surprises of the Alliance’s Hill Day on March 18 was that Hill staff were so willing to focus on topics other than coronavirus. We often started with some discussion of adjustments in work locations and how well calls were replacing what would have been meetings. Once that was dispensed with, we had no problems shifting to FDA’s broad mission and growing responsibilities. This was summarized in a short slide deck (here) that we sent afterwards to Hill staffers as part of our thank-you notes.Of course, coronavirus did play a role in our calls. Every staffer with whom we spoke was already attuned to the importance of the FDA in (1) assuring the health and safety of the American people and (2) its pivotal role in both encouraging innovation and serving as a gatekeeper of the resulting products. Even some of the less well-known parts of FDA’s work were newly meaningful to Congressional staff.Reflecting on those Hill meetings and how different the world looks less than 10 days later, the Alliance needs to focus on three aspects of FDA responsibilities that need Congressional attention and FY 21 funding.First, is the agency’s pivotal role in fighting the pandemic. It is FDA’s public health and regulatory expertise that will assure Americans that only safe and effective products are being used. While public discussion tends to focus on diagnostics, therapeutics, and vaccines, the agency has a similar role with the medical devices that are ubiquitous in the current efforts. Just a few examples of the latter: cotton swabs, medical gloves, and surgical masks are all part of FDA’s responsibilities.Second, the Alliance and the stakeholder community must focus Congress on the resources that FDA needs to anticipate, prepare, ameliorate, or prevent the next large-magnitude, highly-consequential event. Because we are in the midst of a global viral pandemic, we tend to think in terms of “what should be done differently for the next viral outbreak.” However, an FDA resourced to prepare for the unexpected needs to be ready for food supply interruptions, agro- and bio-terrorism, breakdown of both medical and food product supply chains, natural disasters, and so on.Third, but hardly least, we can’t let the immediate focus on coronavirus and future crises distract from ensuring FDA has the resources needed to carry out its entire set of responsibilities. To name a few -- safe food, the advancement of cell and gene therapies, cybersecurity, and the agency’s worldwide inspection network -- don’t lose their importance just because our immediate focus is on the pandemic. If these, and many other parts of FDA’s mission, are short-changed in the FY 21 budget, then there are consequences that undermine the health and safety of the American public.As always, the Alliance welcomes your questions and is eager to work with you to advance the case for a well-resourced FDA.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.