Monday, February 14, 2011

The Safety Czars (Parents and FDA) are Over-Regulating Us to Death

Valentine’s Day used to be about excitement, anticipation and a little bit of danger.  How would she respond to my Valentine?  Would he send me flowers?  Today, in schools and elsewhere, there is often no longer a sense of excitement and danger.  It has been replaced by duty and security.  Everyone in class must send a Valentine to every other person and Hallmark has mandated that we acquire items for our spouses and assistants or we are the schmuck in the room.  Valentine’s Day has become a safety net for an amicable way to say “thank you for who you are and what you have done for me for the past year.”  The Day has somehow lost its special place in the hearts of those in love or looking for love.
The process that has transformed Valentine’s Day is what I term the process of “safetification” that has transformed America slowly but surely over the past generation.  Modern American society appears to want a feel good insurance policy for a wide variety of activities.  Everyone gets a trophy for participating.  Parents, Coaches and Teachers are contributing to this new policy approach.  We are not the same nation of entrepreneurial thinkers and risk takers that we were even a generation ago when little league and soccer teams had tryouts.  Yes, the people of our great nation still come up with great ideas such as Facebook, but there are so many more obstacles and impediments to progress and entrepreneurship than there used to be in the past and these obstacles begin in childhood with how parents raise their children today.  And they culminate in our approaches to regulatory stances we take in the modern administrative state.  
I don’t know how safety has come to be perceived as one of the Über Values in our society.  Not so terribly long ago, mothers ate blue and other moldy cheeses and tuna and salmon and other fish filled with mercury and their children did not wind up with stunted development or birth defects in statistically significant numbers.  
A generation ago, children of a certain age often did not ride with car seats and (perish forbid) booster seats and they skateboarded and rode bicycles routinely without helmets.  Moreover, households did not have funky locks on doors and cabinets that frequently today frustrate parents.  There were no play dates and a parent could not reach his or her children anytime via cell phones; walky-talkies simply did not have sufficient range to keep track of where children were for much of the day. 
The children of a generation ago somehow survived these dangerous, traumatic experiences without protection and constant contact with parental units and went on to build some very impressive entrepreneurial enterprises in adulthood.  They built Apple and Dell Computer and Microsoft Corporation.  They created AOL, Netscape and Google.  They helped build Amgen, Genentech and Biogen Idec.  Will we see the same type of innovation in the future from the generation of helmet wearing, play-date arranging responsible and safe children?  I hope so, but I am not sure.  They may not be as risk taking as their Indian, Chinese or Vietnamese counterparts.
Today, the American regulatory environment that many companies face seems almost oblivious to any sense of risk versus reward.  The focus is solely on the risk and attempts to reduce risk at almost any cost.  There is no sense of giving consumers individual personal responsibility and freedom of choice.  The mantra appears to be “let’s treat them all as we treat our children today and create a safe environment for them.”  Everyone must wear figurative helmets, have arranged play-dates and have a cell phone so we know where they are.
Like the parents of the past, our past regulators used to look out for egregious excess and attempt to protect the public/children from truly unscrupulous types and real danger.  Now, regulators have become an impediment to innovation and growth. 
We are witnessing this scenario play out today with entrepreneurial companies that have produced drugs to fight obesity.  And, for example, I wonder whether FDA is the problem and no longer part of the solution for public health.  FDA has become so consumed with safety that there is no longer a balance of risk versus reward.  The Agency has forgotten the old adage that often the difference between a poison and a medicine or drug is dosage.  Witness what happened with Orexigen (NASDAQ: OREX) recently and what may happen with Vivus (NASDAQ: VVUS) in the not-too-distant future.  I can only hope that FDA comes to its senses by the time Vivus again seeks FDA approval.  The greater risk is in not considering the benefits in drugs designed to tackle the scourge that obesity has become in modern society.  Perhaps we need more of the mindset of parents from the 1950s and 1960s and less of the mindset of the parents of today? 

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