Seeing the FDA in the Mirror

October 4, 2011 |  by  |  FDA

The title of Scott Gottlieb’s Wall Street Journal article “How the FDA could cost you your life” is not only sensational, but misguided.  I am no apologist for the FDA’s poor execution, weak resources and lack of transparency; however, the agency’s existence and culture are a direct response to what American society values.

Almost every product improves in successive iterations through experience and new technology.  Just look at the iPhone compared to the original Motorola “brick” cellphone.  Since medical devices affect human life and health, the flaws in a first iteration of a product, however, have unique risk issues.

The FDA struggles with balancing risk vs. benefit of new medical devices because American society is resistant to accepting risk with any product or service, never mind one that directly affects health.  Clearly, this manifests itself in the litigious nature of American society, but it cuts much deeper.  If anything goes wrong in our lives, someone has to be blamed.  The immediate response is not to determine steps towards improvement, but to assign fault.

Dr. Gottlieb complains about faster approval times in the EU and Americans traveling abroad for experimental devices.  We cannot pretend that Americans have the same national personality as Europeans.  So, how can we expect our institutions to be more like the European Union (EU)?  Have you ever heard of a large product liability suit in Europe?  I’m sure irresponsible companies are penalized by the EU, but the consumer is less likely to be the plaintiff.

The truth is that Americans cannot have it both ways.  We cannot have a zero tolerance for adverse events and simultaneously demand more rapid FDA approval of very invasive products.  And, it is naïve to expect equivalent safety and efficacy without FDA regulation.

I agree with Dr. Gottlieb’s premise that delaying product approvals may be sacrificing more lives than the complications of premature approvals would have caused.  But, once again, this is a calculation based on risk-benefit.  If we as a society are unwilling to balance risk vs. opportunity, it is impossible to expect bureaucrats to do otherwise.

The fact is that Europeans have accepted more risk in their use of medical devices and have earned the right to gain product approvals more expeditiously.  By the way, that does not mean that the average European can get these products sooner since reimbursement is an additional challenge within the EU.

If we want products like percutaneous heart valves approved faster, clinical trials must include less patients and have less stringent outcomes.  Statistically, however, it takes a very high number of study subjects to prove an anomaly that occurs in 0.1% of patients.  Engineering testing is not fool-proof and cycling tests are not 100% representative of the human body.  Thus, even without the FDA’s incompetence, the candle cannot be burned from both ends.

Of course the FDA needs to improve dramatically.  And, we should continue to exert pressure on the FDA to be more accountable for streamlining its processes and improving the skills of its workforce.  Recent actions such as reviewer certification and guidelines for 510K clinical studies are steps in the right direction.  Placing greater emphasis on post-approval data and product monitoring may also help lessen the burdensome nature of initial FDA approval data.  But, we need to not only look at the FDA, but ourselves in the mirror.

The irony of American culture is that we are the most entrepreneurial people in the world, which requires significant personal risk, while confronting unknowns, in the quest to earn great rewards.  Yet, sharing risk in most other aspects of our lives is unacceptable.  We have built the FDA in our own image.

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