The FDA gets criticized from both sides of the debate on how tightly to monitor and regulate new drugs as they are tested and brought to market. They are attacked for under-regulating and also for over-regulating. The then Institute of Medicine, (now the National Academy of Medicine), in a 2006 report advocated more regulatory powers for the federal agency. This is hardly surprising from an organization that is part of the United States National Academies, along with the National Academies of Science and Engineerings, as well as the National Research Council. Getting a perfect clinical trial – always an impossibility but always a goal – that contains as little bias as possible is a great way to do research. There’s a problem, however, with this approach. People’s lives may be at stake in clinical trials, and the possibilities of aiding the terminally ill are far more important for some people than getting a perfect sample and an airtight clinical trial.

Politically, as Michael D. Green writes in his book Benedictin and Birth Defects, Congress has never gone after the FDA for not approving a new drug when the agency had doubts about its safety. But they do go after them with countless investigations when a new drug is approved and turns out to have unforeseen hazards or negative side-effects. You approve a new drug and you may very well be investigated. You disapprove of a new drug and it’s not even news.

Until now. The risk-averse behavior of the FDA given the tilted political environment in D.C. is now being eclipsed by another flaw in the agency. It is a centralized one-size-fits-all body in Washington that decides the rules for drugs across America. Could it be that in certain cases, local works better? This is not an easy devolve-back-down strategy because cancer is cancer no matter in what city or state it shows up in a patient. But when it comes to terminal patients willing to try risky new and unapproved drugs to try and help improve their desperate situations, don’t they have a right to try them?

Right to Try legislation has now been passed in dozens of states of all types of political colors. This is a bipartisan issue and one that points to a reformed and flexible FDA in the future. There is another problem however. Litigation. And that is one that Congress – perhaps any Congress – has been and remains unwilling to solve.