Uncertainty at FDA Impacts Innovation and Patient Care
August 02, 2010
by Mark Leahey
This report originally appeared in the July 2010 issue of DOTmed Business News
If things continue the way they're going, the United States' position as the leader in medical technology and innovation is at risk. As the U.S. Food and Drug Administration's (FDA) premarket review process has become less predictable, U.S. companies are headed overseas to market their products in Europe.
Back in 2008, a handful of anonymous FDA product reviewers raised concerns with the current premarket review process. This vocal minority created an environment where FDA managers and reviewers have become much more risk-adverse, and at times reluctant to provide a reasonable pathway to market. Though the anonymous reviewers provided no evidence to back up their concerns, they succeeded in slowing down innovation and improvements to patient care.
Losing the medical technology market to Europe is disconcerting. It means patients in the United States will not have timely access to safe and effective products. Further, companies that manufacture and sell products create well-paying jobs for Americans. All of that is lost as the market moves overseas.
Small medical device and equipment companies are especially hard hit financially in this current environment. There are countless stories of a completed trial that has been approved by the FDA, and upon completion, the FDA tells the companies to add in another 50 subjects to its trial or extend follow-up another two years. The message is essentially, "Good, but not good enough," with the goal posts constantly moving.
Those might seem like minor issues to the average person, but increasing a clinical trial size by 50 patients or adding follow-up years is prohibitively expensive, and doesn't necessarily add benefits to patients. Given the significant dollars associated with these post-trial requests, smaller companies often don't have the ability to raise more funds to satisfy these requests and continue operations. As a result, patient care, innovation and jobs suffer.
For example, companies spend about $1 million every month during development of a medical device. Adding two years to a clinical trial would cost an additional $24 million, and that's not factoring in costs for the product once cleared or approved. Increasing a clinical trial size from 100 to 150 patients can cost companies millions more. As it is, some companies spend more than $100 million before they're given a chance to market in the United States, and these figures rise every day. This is detrimental to patient care, innovation and job creation.
This report originally appeared in the July 2010 issue of DOTmed Business News
If things continue the way they're going, the United States' position as the leader in medical technology and innovation is at risk. As the U.S. Food and Drug Administration's (FDA) premarket review process has become less predictable, U.S. companies are headed overseas to market their products in Europe.
Back in 2008, a handful of anonymous FDA product reviewers raised concerns with the current premarket review process. This vocal minority created an environment where FDA managers and reviewers have become much more risk-adverse, and at times reluctant to provide a reasonable pathway to market. Though the anonymous reviewers provided no evidence to back up their concerns, they succeeded in slowing down innovation and improvements to patient care.
Losing the medical technology market to Europe is disconcerting. It means patients in the United States will not have timely access to safe and effective products. Further, companies that manufacture and sell products create well-paying jobs for Americans. All of that is lost as the market moves overseas.
Small medical device and equipment companies are especially hard hit financially in this current environment. There are countless stories of a completed trial that has been approved by the FDA, and upon completion, the FDA tells the companies to add in another 50 subjects to its trial or extend follow-up another two years. The message is essentially, "Good, but not good enough," with the goal posts constantly moving.
Those might seem like minor issues to the average person, but increasing a clinical trial size by 50 patients or adding follow-up years is prohibitively expensive, and doesn't necessarily add benefits to patients. Given the significant dollars associated with these post-trial requests, smaller companies often don't have the ability to raise more funds to satisfy these requests and continue operations. As a result, patient care, innovation and jobs suffer.
For example, companies spend about $1 million every month during development of a medical device. Adding two years to a clinical trial would cost an additional $24 million, and that's not factoring in costs for the product once cleared or approved. Increasing a clinical trial size from 100 to 150 patients can cost companies millions more. As it is, some companies spend more than $100 million before they're given a chance to market in the United States, and these figures rise every day. This is detrimental to patient care, innovation and job creation.
1(current)
