From the Archives: The FDA Is Showing Its Age

This op-ed originally ran at U.S. News & World Report.

A supercentenarian is a person who has lived passed their 110th birthday. We celebrate that for people, but it's not clear that we should celebrate it for a federal agency like the Food and Drug Administration, which turns 110 this year.

It's certainly time to re-evaluate precisely what such an agency ought to be doing, not to mention what it should not be doing. Two things that federal agencies like the FDA should avoid in particular are scandals and poor outcomes.

Typically the scandals are what dominate the news, but what may be most damaging to the country are the poor outcomes from these agencies. Some, such as the chronically poor care at veteran's hospitals, are easy to see and document. These sorts of highly visible scandals and outcomes outrage the public and Congress – and action usually follows – but there's no parallel outrage for poor outcomes that are widely distributed and difficult to attribute.

Those sorts of poor outcomes are precisely what plague the FDA, and here's why: The FDA has, over the last 50 years or so, added more and more obstacles to new technologies. These include individualized drugs, medical devices using nanotechnology, and cellular therapies, which ultimately will keep have the possibility of keeping us healthier and prevent us from dying young needlessly. But the FDA's laws governing these technologies are 40 to 50 years old for medical devices and drugs, respectively.

A big part of the problem that the FDA suffers from is the nature of publicity. No one applauds the FDA when it approves a product that ought to be approved quickly, yet there is outrage when an approved drug or medical device turns out to be ineffective or unsafe. But given the fact that there are 319 million U.S. consumers who are both biologically heterogeneous as well as heterogeneous in their use of products, it's impossible to test every product using relatively small populations to be default free.

There are two ways to remake an agency that suffers from poor performance and scandal: Change the incentives or change the mandates. After 110 years, the FDA's incentives are mostly baked in. No doubt many new commissioners have tried to change the culture, but the incentives still stem primarily from an early 1960s case where a drug was approved but later proved problematic. Cases like this one drive the FDA to be precautionary. While it may seem logical to be better safe than sorry, it is a "deeply incoherent" guide for public policy. It takes the necessary balance out of the equation that must compare the benefits of allowing a new technology that saves patient's with the possibility that it may also do some harm or fail to improve them.

If a new commissioner can't change the FDA's culture, another option is to change the authorities – i.e., the mandates – given to the FDA. For example, just as the Europeans do, we could have competing private approval bodies for the vast majority of medical devices.

For drugs, the FDA can return to ensuring that they work for their intended outcome, instead of trying to do the doctors' work for them by ensuring clinical outcomes. As author and scholar Joe Gulfo notes, "The FDA's current approach of requiring definitive proof of clinical outcomes in very large, time-consuming and expensive trials prior to market entry is flawed because no trials can be large enough to amass the information that is required to see the real-world value of new compounds before approval, and the costs and time are prohibitive.

A better approach would be for the FDA to approve drugs that have shown the intermediate activity, e.g., change in blood pressure and can be labeled for safe use in defined populations." Such an approach would vastly reduce the cost and time to get drugs to markets and return the practice of medicine appropriately to doctors.