The interim report from the President's Council on Jobs and Competitiveness is out, and one of its key recommendations (in the section on simplifying regulatory reviews) is to improve the FDA's approval process. Here's the key takeaway:
...our medical innovation ecosystem is in jeopardy. Investment in the life sciences area is declning at an alarming rate, because of the escalating cost, time, and risk of developing new drugs and devices. While many factors have contributed to this decline--including challenges around reimbursement and the general state of the economy--an important factor is the uncertain FDA regulatory enviornment. These concerns come at a time when Europe, China, and India continue to entice companies to take their medical research and development enterprises abroad, putting at risk our ability to keep private investment and jobs here at home.
To underscore its recommendation, the report notes that in 2010, while the U.S. venture capital invested in biotechnology companies fell by 3%, European investment increased by 30%.
The Council's recommendations are relatively mainstream - in fact, several are already included in the recent PDUFA V technical agreement, like developing a better framework for weighing the risks and benefits of new therapies and diagnostics with input from stakeholders, patients, and consumers. The report also recommends the adoption of a progressive approval framework, based on its current accelerated approval pathway.
These are all good ideas. They aren't radical, but they move the ball in the right direction. Kudos to the Council for focusing on medical innovation, and recognizing the role that regulations can play in advancing innovation and entrepreneurship, or strangling it on the vine.