Is excessive regulation to blame for stifling pharmaceutical research?
Every day brings some new tale of horror; unsuspecting customers duped by a greedy pharma peddling a toxic drug or malfunctioning device. Headlines read: They Knew; Should Have Known; Could Have Prevented. Constant drumbeats reinforce the notion that, without Food & Drug Administration (FDA) oversight (and plenty of plaintiffs' lawyers), corpses would line the streets.
The FDA's mission is to protect the consumer. They are the white hats, the good guys who are perennially untroubled by imposing additional trials or larger patient population samples on manufacturers, or meticulous and lengthy decision making processes within universities and federal agencies. Why should they be? According to ex-FDA commissioner Alexander M. Schmidt: "In all of FDA's history, I am unable to find a single instance where a congressional committee investigated the failure of the FDA to approve a new drug. But, the times when hearings have been held to criticize our approval of new drugs have been so frequent that we aren't able to count them....The message to FDA staff could not be clearer."
Imagine if we approached automotive safety in the same way that we approach drug and medical device safety. Would any new car model ever make it to the showroom? While each defensive regulatory decision is likely justified in and of itself, when you add them up, the costs begin to outweigh the benefits, or even common sense itself. In fact, the price of bringing a medicine to market, per billion spent, in constant dollars, has increased by a factor of 100 times over the last sixty years. This is Moore's Law in reverse.