Life Extension

The FDA is Broken

The Food and Drug administration is stifling innovation. The snail pace at which the FDA approves new drugs and procedures is forcing research and development money to flee U.S. markets for more cost effective opportunities. Countries like China, Singapore, and Israel fast track the process for bringing life saving drugs and treatments to market.

A process that can take five or six years in the U.S. is being done in six months elsewhere. And they are saving lives. The aforementioned countries allow for contemporaneous human and animal research trials, thereby getting life saving drugs into the patients who need them the most. Forgive me for sounding callous, but if you are given six months to live you’ll try anything. The drug may or may not be successful, but at least you have hope.

In a Wall Street Journal piece, Doctor Andrew von Eschenbach summed it up thusly:

“The FDA is the regulatory gatekeeper for every drug and medical device sold in the U.S. But there is a growing recognition—at the agency, in the industry and among patients’ groups—that it is at serious risk of falling behind its core responsibility of evaluating new medical products in a timely and predictable manner. Without an FDA that is as innovative and sophisticated as the companies it regulates, patient health and U.S.-based innovation will suffer.”

FDA Commissioner Margaret Hamburg conceded to Congress in 2010, “the FDA is relying on 20th century regulatory science to evaluate 21st century medical products.” That’s not the only problem.

Unanticipated side effects of high-profile drugs like Vioxx have pushed the agency to require more data and larger clinical trials from companies to search for rare adverse events. The Tufts Center for the Study of Drug Development has reported that clinical trials from 2003-2006 were nearly 70% longer than those from 1999-2002. Longer (and more complicated) trials have led to skyrocketing drug-development costs. High costs discourage investment in much-needed new therapies for conditions like diabetes or heart disease.

The agency is also broken into Centers dealing with drugs, biologics and devices. Yet, increasingly diagnostic devices will be paired with therapeutics. And crucially, efforts to prevent diseases like Alzheimer’s will require an entirely new approach to designing clinical trials—one that relies on “biomarkers” to rapidly measure a drug’s effectiveness and safety in small, targeted groups of patients rather than in large, randomized clinical trials with thousands of patients that can take years to complete and analyze. In a world where science is advancing at an exponential pace, the FDA must be capable of ensuring that its reviewers know just as much about advances in emerging sciences as the creators of the products they regulate.” (Click here for the full text)

Here’s the most objectionable part: the U.S. does have a system for getting experimental drugs to patients, but its accessible only to the rich and powerful. It involves getting onto experimental drug trials, a process closed to the vast majority of us. This would not be such a nightmare if the FDA were employing 21st century processes to evaluate modern drugs. But they are not. The trials go on for years when they often could be ready for approval now.

So, at a time when our best hope is to innovate our way out of the doctor shortage, enter ObamaCare. We are marching toward the most restrictive and cumbersome set of Federal Laws ever contemplated. Enter private hospitals, medical tourism, and hospital ships like the Pura Vida.