No Need for a Crystal Ball in Some Scenarios

FDA -- along with NIH, CDC, and other front-line public health agencies -- is caught up in the urgent COVID-19 efforts. Appropriately, enormous resources are being devoted to fighting the pandemic and more funding will come, if needed. At the same time, we are getting positive reports on the FDA’s efforts to carry out the rest of its mission. The agency is still assuring that our food is safe and that we have access to medical products that are both safe and effective.Beneath all of this is another interesting and important story. Science and technology are advancing so rapidly that the FDA’s workload is certain to significantly increase in 2021, independent of the agency’s pandemic fighting activities. Failure to anticipate the acceleration of science and technology and provide additional funding to FDA will result in delayed milestones and missed opportunities to improve the public health in the United States.The most immediate example is the past failure to provide enough resources to match the rapid growth of products being developed using cell and gene therapy. CBER has over 900 active INDs and is accruing more than 200 new cell and gene therapy INDs each year. Prior planning anticipated a much lower number of INDs and a much slower growth in the resources needed. In its advocacy, the Alliance has stressed that this needs to be addressed in FDA’s FY 21 appropriation.However, a crystal ball is not required to anticipate some of next year’s expanded needs. The clues are in the here and now.For example, there will be a renaissance in vaccine development, probably starting later this year. Billions of dollars are being spent on developing a COVID-19 vaccine. New data and new insights from that effort will speed up the identification, development, and manufacture of vaccines for other diseases. FDA will need more staff to handle this.There is even an interesting potential for crossover between FDA’s two core missions. As reflected in a Food Safety News story this week (here), a vaccine is needed to prevent norovirus infections that cause viral gastroenteritis and are often transmitted through food. Success in this regard might “prevent 109,000 hospital admissions, 465,000 emergency room visits, and 2.27 million urgent care visits.”Finding a vaccine against coronavirus will turn out to be more than just developing a new vaccine for our current emergency. If we don’t anticipate this and fund FDA’s broader vaccine programs properly, then they will be where cell and gene therapy are now -- behind the curve and needing massive infusions of resources to catch up.Vaccines are not the only area in which predictable challenges and opportunities will result in FDA needing more resources in FY 21. I will address some of those in future columns.FDA’s budget keeps growing -- indeed, needs to keep growing -- because science is growing more complex, but is also becoming more capable of addressing important public health needs in the United States. This transformation is largely invisible, but has important implications for FDA resources. Simply, we need to plan ahead for where science and technology will take FDA. If not, we risk roadblocks in the path of progress.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.