Everything in life is inherently risky. Each day, thousands of people are injured driving on roads or walking on public streets.
In America we are risk takers. We were the first to fly a plane, send a man to the moon and first to take a risk on discovery and development of countless medical products. Often, however, decisions are based on the fear of the unknown, and with that fear benefits are easily overshadowed. Unfortunately, the FDA is bound in the grips of this fear.
Over the past several years, FDA and Congress have created significant obstacles for pharma and medical device companies to bring new medicines and technologies to the market to improve the lives of Americans. As Steve Forbes noted in a recent editorial, FDA has made the “approval of new drugs ever more expensive—with nothing to show in efficacy and safety.” The FDA has regularly changed requirements for clinical trials, making it harder, slower and more costly to develop new products. In doing so, FDA is taking its own risk: letting patients die waiting for medical products in regulatory limbo which prevent the potential of new or modified medical products from being realized.
Companies however are not waiting. Instead, innovation and science are leaving America and going to countries like Brazil, China and India, where approval takes half the time and the process is more certain. Is this how Americans expect our economy to bounce back?
Ultimately, while all breakthroughs and innovation come with some risk, Americans and the FDA will have to decide whether they are willing to accept yesterday’s therapies rather than taking a risk on new technologies.
Tom Sullivan is president of Rockpointe Corporation
From the March 01, 2011 Issue of MM+M - Medical Marketing and Media
