The 21st Century Cures proposal, recently passed by the House of Representatives’ Energy and Commerce Committee, embarks on a noble goal—improving innovation in health care. The good news is, all involved in the effort appear to agree that the current state of the Food and Drug Administration’s product approval processes is a serious impediment to innovation and cures.
But not everyone agrees on what innovation means or how to achieve it. Former FDA commissioner Hamburg recently criticized the 21st Century Cures bill: “Shortening review times is not going to create the scientific understanding and the research and development that needs to be done to translate exciting opportunities in science into new products.” That statement begs the question: to what degree is government actually a generator of revolutionary innovation?
It’s important to distinguish between government innovation and areas where government contributes to an environment that leads to private sector innovation. Sectors praised for their innovation, like high tech, operate with low or non-existent government barriers. This is easy to see with the app market, where upwards of 300 are created each day. If innovation is the objective, it’s much more important to eliminate costly and timely approval barriers than it is to create new federal programs. Adding more complexity to an already complex system is not likely to generate the innovation our health system desperately needs.
For years, we have seen that the FDA does not speed up innovation; it slows it down. For drugs, these delays mean companies spend an average of $1 billion and 10 years to go through the FDA’s laborious system. To come into the 21st century, we need to totally rethink the FDA pre-market approval and the medical device “notification” process. These ideas are unlikely to come from those vested in the current system. Both medical device and pharmaceutical systems were created 40 to 50 years ago and approvals have been slowing down ever since. Unfortunately, this bill would give the FDA more authority and more money which is likely to further impede the process, rather than improve it.
Between the FDA and NIH, this plan appears to create at least eight new programs, three public/private working groups, four strategic plans, 11 new reports, and 15 guidance documents. Although some of this may be useful, these changes operate as add-ons to an already complex structure at FDA. If the goal is “to accelerate the pace of cures and medical breakthroughs in the United States, then we need to look to new models where we have competition to ensure safety and effectiveness as well as timely approvals. It’s not that we need new mechanisms of approval on top of the old ones, we need to critically rethink the old ones.
Retaining the current FDA structure while building new similar structures will add costs to an already expensive governmental system. It is also unclear whether funding this bill will result in more user fees. User fees were created with the intention of speeding up review of medical devices and pharmaceuticals, but we are still far too slow compared to our European counterparts.
Congressional estimates suggest that we have perhaps 500 cures for 10,000 known diseases. Imagine, if we could free up the tremendous innovative power that we are seeing in technology markets, how much faster we could move to save lives today. What’s more, medical costs are far, far too high and regulation will not solve that problem. Rather than continuing to build upon a system that punishes health innovation and delays lifesaving cures, we need fundamental reform.
History tells us that despite the best of intentions, this bill will only provide a temporary fix for the FDA’s structural problems. A thorough, retrospective review of the FDA’s policies would allow for the barriers to health innovation to be identified and dismantled. Only then we can start building an FDA equipped for this century, built on true 21st century models of innovation.