FDA in the way of jobs and cures

Posted: November 13, 2011

Joe Pitts

is chairman of the House Energy and Commerce health subcommittee

Our nation has long admired the ingenuity and innovation of inventors. You cannot tell the history of America without talking about Fulton's steamship, Bell's telephone, or Ford's assembly line. American inventiveness has propelled our economic growth.

In particular, America has led the world in medical innovation. In seven of the last 10 years, an American has won or shared the Nobel Prize in medicine. Most of the top-selling medical devices were invented in the United States.

Medical-device companies provide two million jobs nationwide, and pay an average of more than $60,000 per year. More than 22,000 Pennsylvanians work in this field.

While the United States has a clear lead, the rest of the world is doing its best to catch up. European and Asian nations have been making great strides. Competition is healthy. It can drive innovation even faster. But some of the foreign gains have been made not because of ingenuity, but because U.S. companies are being held back by the Food and Drug Administration.

Medical devices have to go through a rigorous approval process. For good reason, companies are required to submit their devices to scientific tests to determine safety and effectiveness.

But in recent years, the FDA's approval process has become a bottleneck. It has become less transparent, less predictable, and less efficient. Some companies have waited years for approval, spending millions on testing only to have the rules change.

InfraScan of Philadelphia has created a noninvasive device to detect brain injury. The company's Infrascanner uses near-infrared light to detect bleeding in the brain. In just a few short minutes, the device can warn medical professionals that an injury is serious and that the patient should be rushed to a hospital.

InfraScan's technology was developed with U.S. military in mind. The device is portable enough that it can be deployed in the field. In fact, the development was partially funded with grants from the Marine Corps and the National Institutes of Health.

In early 2008, InfraScan applied to market the device in the United States, and has been trying to work through the FDA approval process since.

By contrast, the device was approved for use in Europe in 30 days. U.S. allies are using the Infrascanner on the battlefield right now, yet U.S. soldiers serving next to them do not have access to this lifesaving device.

I chaired a health subcommittee hearing earlier this year where we heard from other companies struggling to gain approval. Some firms and investors are giving up on the United States and moving operations overseas where their products can be sold.

We should not lose these good jobs. My colleagues on the Energy and Commerce Committee recently introduced a series of commonsense FDA reforms. These 10 bills try to make the FDA more predictable. One bill encourages the FDA to work with foreign regulators to harmonize requirements. Another provides incentives for devices to treat rare diseases. Other bills try to make FDA processes more transparent.

The human body is infinitely complex, but the approval of devices to heal the body doesn't have to be. We need the FDA to make sure that devices are safe, but we don't need them to stand in the way of cures or jobs. New inventions and cures will only come if inventors have a clear path to bring their product to market.


U.S, Rep. Joe Pitts represents Pennsylvania's 16th District, which comprises Lancaster County and parts of Chester and Berks Counties.

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