Keeping Up with Progress Costs Money!

The Alliance is often asked: why does FDA’s budget need to grow each year?Among other things, we point to: a large number of new agency responsibilities over the last decade; the growing scientific complexity of the products FDA regulates; and the burgeoning globalization of food, drugs and devices. In addition, FDA has an explicit mission that it didn’t have a decade ago: encouraging innovation rather than just regulating it.Today’s column looks at one aspect: how innovation and scientific complexity are a constant challenge to FDA and require long-term vision, as well as a well-educated, forward-looking workforce. The creation, growth, and potential of 3D printing (also known as additive manufacturing) provides a wonderful example. It is a transformative technology, but hasn’t gotten widespread public attention for its role in FDA-regulated products.3D printing uses a digital design/file to create a solid three-dimensional physical object by adding material layer by layer. The layers can be seen as a thinly sliced, horizontal cross-section of the eventual object. 3D printing enables the production of complex (functional) shapes using less material and greater customization than traditional manufacturing methods. As the technology has advanced, costs have come down and you can even buy $500 and $1,000 3D printers on Amazon.So far, FDA has approved one drug based on 3D printing technology -- a rapid dissolving drug for epilepsy. An article this week described a Swedish company using 3D technology to print cancer tumors for research and drug testing. Other uses are under development, such as pre-manufacturing prototypes and possible applications to personalized medicine. Companies interested in this technology can work with CDER’s forward-looking Emerging Technology Program.CDRH is even more involved, as it examines the potential effects of 3D printing on safety, performance, fit, and functionality of medical devices. In a Guidance document released in December, the Center provided a comprehensive technical framework and regulatory clarifications for devices manufactured using 3D technology.In yet another area of FDA: 3D printing of food is still in the early stages but may grow quickly in the next few years.Some say that 3D printing is an emerging field that is likely to become a mainstay of FDA technologies. I guess someone will write me to say the current and future impact of 3D printing is over-hyped. Regardless, my point is what this shows about FDA -- the agency is looking to the future, appropriately putting resources into smoothing the way for new developments that will benefit consumers and patients. The key is the pace of innovation and FDA’s commitment to say ahead of the curve.FDA’s role in emerging technologies is a feel-good story, saying as much about FDA as the much-headlined number of novel drug therapies approved in 2017. It shows FDA at its best, doing things that are incredibly valuable but rarely chronicled. However, all this foresight comes to naught if the agency doesn’t have the budget and workforce to do its job well.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.