Hearing of the Health Subcommittee of the House Energy and Commerce Committee - 21st Century Cures: Examining the Regulation of Laboratory Developed Tests

Hearing

Congressman Michael C. Burgess, M.D. (R-TX), vice chairman of the House Energy and Commerce Subcommittee on Health, today issued the following opening statement at a hearing titled "21st Century Cures: Examining the Regulation of Laboratory Developed Tests":

I have attended every Cures event in DC and several across the nation.

Repeatedly we hear of the potential of genomic medicine to understand illness, quickly diagnosis it and target treatment. This has been embraced in a bipartisan manner.

I strongly believe in this potential. Here's an example:

A few months ago, CDC briefed my staff on an emerging global health threat in the form of a virus. They had sequenced the virus, provided information to researchers and even knew where in the particular country's jungle the virus originated. It was impressive to say the least.

Here's one more: Back in 2009, H1N1, a subtype of the Influenza A virus, spread rapidly.

During the first week of the outbreak, 16 laboratories had LDTs that could identify H1N1 from other H1 viruses. Most results were available within 24 hours. The speed helped inform public health reactions.

The FDA had no approved commercial kit. If they had, under the proposed framework -- even if it was 15 years old and inferior -- these LDTs would have been blocked from doctors and public health officials.

FDA regulation of tests like these will be burdensome and will slow the ability of clinical laboratories to develop tests that can allow us to respond to public health crises. It is also duplicative -- Congress already established a regulatory framework applicable to labs and laboratory testing, known as CLIA.

However, I have conceded additional review of certain tests may be warranted. Previously, I introduced legislation to meet patient needs and ensure tests are accurate, reliable and clinically valid by making improvements to CLIA.

I authored section 1143 of the Food Drug Safety & Innovation Act so we would be able to discuss how patients, the practice of medicine, innovation and the economy would all be harmed if FDA tried to fit LDTs into the misaligned definition of medical device. I fundamentally believe FDA has no statutory authority to regulate LDTs.

For FDA to have jurisdiction, it must be a traditional device and be commercially distributed among states. LDTs do not fall under either category.

Professional medical services are not regulated by FDA.

If they start to be, we are effectively opening the door to the federal regulation of the practice of medicine. I adamantly reject and will vehemently oppose that notion.

In addition to these significant jurisdictional issues, the process FDA is considering is of great concern. Even if the courts determined FDA authority over LDTs, the agency would need to amend its current regulations through rulemaking.

The FDCA, the Administrative Procedures Act and the Supreme Court all require disseminating rules to modify current regulation or to create legally enforceable regulations.

Instead, the FDA continues on its jurisdictional power grab by attacking innovation, threatening professional practice and risking countless jobs in order to claim authority over all they see. They are doing this even at the expense of allowing the core mission of the FDA to suffer as a consequence.

I can't think of a worse result: denying patients and doctors innovative tests while redirecting resources that could be used to approve the next miracle medical device or drug.

I thank you for the hearing and yield.

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