Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX), vice chairman of the House Energy and Commerce Subcommittee on Health, today responded to the Food and Drug Administration’s (FDA) notification to Congress that it will release draft guidance to regulate laboratory developed tests (LDTs) with the following statement:

“Applying FDA’s regulatory approach to LDTs is redundant, will stifle innovation and will require additional taxpayer funding for the FDA. To the extent concerns about ‘higher-risk’ tests exist; these can be addressed at no cost to the government through a modernization of The Clinical Laboratory Improvement Amendments (CLIA). 

“Given the negative impact these policies – if pursued – could have on innovation, I am glad I was able to secure this notification requirement within the Food and Drug Administration Safety and Innovation Act of 2012. LDTs are not medical device products sold through interstate commerce. They are services provided only to the ordering healthcare provider and offered only by labs that validate and develop them. Professional medical services are not regulated by FDA. More importantly, the question of agency jurisdiction over LDTs has never been legally clarified.  LDTs neither constitute “medical devices” nor are commercially distributed among states – both requirements for FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FFDCA).

“FDA is the subject of much criticism from industry groups who are already under their jurisdiction. As such, they are overburdened and take too long to approve products, which increases uncertainty for companies and negatively impacts innovation, as well as patient access to new treatments and devices. If LDTs were regulated as medical devices by FDA, it would significantly tax an already overtaxed agency and stifle access to these important tests.

“The Energy & Commerce Committee is continuing to develop the 21st Century Cures initiative and explore how we can encourage innovation. We are also looking into ways to increase our ability to detect, treat and cure disease. I fear today’s move by the FDA moves in the opposite direction and I look forward to raising this issue often in the coming months.”

Burgess’ provision within the Food and Drug Administration Safety and Innovation Act of 2012 ensured that FDA would have to give Congress 60 days’ notice and a full description before enacting regulations such as this one. For more information, click here. 

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