Time for Some Real Hope and Change in the US Life Sciences Industry
Posted on Fri, Nov 05, 2010 @ 02:54 PM
The recent election results, the proceedings at Biotech 2010, and 
a blog by Matt Herper about the decline of US competitiveness in biotechnology got me thinking: it is time for some real hope and change in the US life sciences industry.
We all want our industry to be on the cutting edge of innovation and global leadership. But let's face it: recently the news has not been good for pharmaceutical, biotechnology and medical technology companies. Between the huge number of job cuts, proposed modifications to the 510(k) regulatory pathway for medical techologies, and the continuous decline in the number of new drugs being approved by FDA annually, one could easily become pessimistic about where the industry is going in this country. Add to all this recent comments from Dennis Gillings, the founder and chief executive of Quintiles Transnational, a major life sciences outsourcing firm. Matt Herper reports in his blog that, according to Gillings, the US is at risk of losing its position as a biotechnology leader to China.
All of this gets me thinking about the divisive dynamics in our political environment and our regulatory environment. And the fact that the current dynamic helps no one.
As a result of the recent election, the president must now work with Republicans if he has any hope of getting things done, and Republicans must also work with the president because they now are in a position where they have to legislate, and be seen to be getting things done in Washington by those who voted for them.
As far as the life sciences industry is concerned, I don't think it would surprise anybody that the decline in new drug approvals in the US has much to do with the FDA's increasing demands on industry to provide drugs and medical technologies with little or no safety risks. Guess what? There is no such thing as a safe drug, and all medical technologies have a certain degree of risk. No matter how stringent our regulatory process becomes, these are facts that will never change.
Now don't get me wrong. The FDA plays an essential role in protecting the health of the American people, and it should continue to do so. But I think that there is a tipping point at which pedantry overwhelms common sense and begins stifling innovation. And innovation is what built the life sciences industry in the United States.
It seems that every industry event I attend these days, and in a number of articles that I'm reading about the life sciences industry, I hear that companies are increasing their focus in ex-US markets to commercialize their products and grow their businesses.
When multiple industry experts lament the decline of a US life sciences industry that at least for now remains the envy of the world, I think it may be time for a less confrontational approach between regulatory authorities and industry. I believe that both industry and our regulatory authorities have an interest in delivering relatively safe, innovative and effective treatments, and protecting the global leadership position of the US in life sciences. This can only happen if we all recognize that our global leadership position is worth preserving, and that everybody, from both government and industry, needs to work together to change the status quo.