By Rep. Cathy McMorris Rodgers (R-Wash.) - 09/20/11 11:31 PM EDT
With the markets seesawing and unemployment rising, creating and maintaining jobs remains Americans’ top priority. Spurring job creation in a field that actually improves people’s lives would be doubly beneficial, which is why health innovation remains a top public policy objective.
The subcommittee on Health began its effort to support and improve patient access to safe medical devices with a hearing to examine how the FDA review process facilitates the approval of devices and accessibility for consumers. The committee is engaging in candid conversations with the FDA, product innovators and patients and using their expertise to assess how Congress can best assist in authorizing the most effective review process possible.
Testimony provided to the committee demonstrates that changes must be made. One life-long developer of medical technologies stated that the environment and cooperativeness of the FDA is the worst it has been in more than 40 years. The FDA spends an average of 1,200 hours reviewing each individual application. This same developer, who has created 10 life-saving and life-improving devices that have resulted in tens of thousands of jobs and billions of dollars in U.S. exports, said he believed that if the current FDA regulations had been in place over the past few decades, he would not have been able to contribute to his field in the way that he has. The change in the FDA review and approval process cannot be attributed to a decrease in resources; in fact, funding for the FDA’s device program has increased from $275 million to $368 million between 2008 and 2010.
Despite this increased funding, applicants regularly complain about a process plagued by unclear guidelines, high turnover rates on the review division staff, impractical clinical trial designs and changing “goal posts.”
A lengthy review process is more than a bureaucratic holdup — it results in devastating ramifications for individuals and families. Many patients have testified that when faced with a medical condition that could turn degenerative or fatal, they were frustrated to discover that life-altering, or even life-saving, treatments were available, but only abroad.
One patient was forced to travel overseas, and eventually succumbed to bankruptcy because she could not purchase a device manufactured a mere 40 miles from her home. No American should be forced to choose between unmanageable travel and medical bills or the onslaught of degenerative symptoms. We could easily give these patients hope by improving timely access to safe medical device advancements by simply streamlining FDA’s overly burdensome review process.
The agency’s onerous and inconsistent review process affects more than just patients: It is hurting our nation’s job creation. Currently, more than 400,000 Americans are employed in the medical technology industry. In 2008, these workers earned $24.6 billion, which breaks down to an average yearly salary of $58,000. These well-paying jobs are jeopardized when patients and healthcare professionals are forced to turn out of necessity to products only available in European and other foreign markets due to an overly lethargic and repetitive FDA review process.
American engineers and developers are wary of getting involved with the FDA and are increasingly taking their business overseas first, because they know their product is likely to be active in foreign markets for years before it has a chance of being accessed in the U.S.
House Republicans feel that Congress has a duty to protect not only American jobs, but also the individuals who require access to necessary treatments. Appreciating the fine line the FDA must walk to maintain safety without blocking access to innovation, we hope both parties can work together and ensure the FDA has a timely and effective review process that supports patients, innovators, and American jobs.
McMorris Rodgers is a member of the House Energy and Commerce Committee’s Health subcommittee.
This post has been updated.