The Hill - We Can't Afford to Let New Regulations Strangle Scientific Breakthroughs from Genetic Testing

Op-Ed

By Representative Micheal Burgess

Healthcare policy and the economic health and future of our nation are inextricably linked. We can no longer afford to make decisions on how healthcare is delivered and paid for without understanding how it affects jobs and economic growth.

Congress hasn't always followed this approach. In fact, we have enacted legislation that has stymied growth and prompted employers to either lay people off or curtail hiring. In medicine, it's malpractice. In politics, it's business as usual.

With unemployment hovering above 8 percent, we no longer have the luxury of pursuing legislative and regulatory initiatives that stall or undermine job creation. We need policies that make sense for patients and add American workers to our economy.

We should start at the same place physicians do when seeing a patient -- diagnosis and testing. In fact, the area of genetic and genomic testing is a bright spot both medically and economically. This testing is saving lives, making healthcare more cost-efficient and, at the same time, creating jobs. There is a legitimate concern that Washington could snuff out this shining light.

There is a movement to change the way genetic and genomic testing is regulated, bringing these services under the purview of the Food and Drug Administration -- the same FDA that is widely criticized for slow review and approval processes, which has led to patients in other countries receiving new pharmaceutical and medical device innovations years before Americans. With the current FDA as gatekeeper, the rapid pace at which we're breaking new ground would slow significantly.

Another reason for not expanding the reach of the FDA is that most new genetic tests are developed in academic, hospital and independent labs, and are already regulated by another federal agency inside the same federal department. Giving new regulatory power to the FDA is redundant. Forcing clinical laboratories developing these tests to undergo the complicated and expensive FDA review process would keep genetic breakthroughs from making the leap from scientific discovery to healthcare delivery and could put these innovative companies out of business.

A new study by the Battelle Institute found that genetic and genomic clinical laboratory testing generates 116,000 new jobs and $16.5 billion in annual economic growth. That means jobs within the laboratory sector but also related jobs in real estate, food establishments and retail sales. Every $1 of economic output by genetic and genomic laboratory testing creates $1.80 of related economic activity in other sectors.

Battelle also points out that America is the global leader in this field. However, other nations are racing to compete. This brings us back to the drive to slap a redundant regulatory system onto this sector. If we slow down scientific progress through regulatory strangulation, those jobs and the economic vigor get shipped overseas.

Improvements in genetic testing are enabling physicians to better target treatment to a patient's unique genetic makeup, and we're seeing markedly improved patient outcomes in a host of diseases and conditions, from childhood leukemia to cervical cancer to HIV. It would be unconscionable to deprive patients of new breakthroughs that can extend life and prevent pain. Likewise, it is senseless to see jobs disappear because of ill-conceived regulatory moves.

These outcomes don't have to happen. Let's dispense immediately with the idea that the FDA needs even more responsibility. I have introduced legislation that would beef up the already existing Clinical Laboratory Improvement Amendments (CLIA) -- the tools currently used to regulate clinical lab testing. A stronger CLIA would give the Centers for Medicare and Medicaid Services the authority to require that new genetic tests show evidence of clinical validity and the power to keep them off the market if they can't demonstrate that value.

Taking these steps protects patients while maintaining the flexibility to allow new, valuable tests to move rapidly from the laboratory bench to the bedside. It would ensure safety without erecting obstacles to stand in the way of life-enhancing innovation. It would also enable continued growth in one of the few sectors actually creating jobs and stimulating the economy.

When I care for a patient, I not only treat the particular condition at hand, but also examine all factors that affect my patient's ability to lead a long, productive life. Congress and federal agencies need to do the same, looking at healthcare policymaking through the prism of what it takes to give our economy a brighter, more dynamic future.

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