Tell the FDA: Keep Your Hands Off Our LDTs!

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Stephen Ostroff
Jeffrey Shuren

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Keep Your Hands Off Our LDTs!

Dear [Decision Maker],

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I understand the FDA sent a letter to Pathway Genomics stating that the company's non-invasive cancer screening test is a medical device being marketed without FDA approval. The FDA seeks to treat LDTs as medical devices, requiring pre-market approval in some cases.

I also know that the House Energy and Commerce Health Subcommittee has suggested that the FDA is overstepping its authority, that your agency's regulatory approach to LDTs in this guidance "is redundant, will stifle innovation, and will require additional taxpayer funding for the FDA." At the September 9 hearing, the subcommittee questioned whether the agency even has the authority to regulate LDTs in the first place. As Rep. Burgess pointed out, LDTs are already regulated through the Clinical Laboratory Improvement Amendments, which is overseen by Centers for Medicare and Medicaid and does not require further FDA oversight.

Rep. Burgess also noted that 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, and professional medical services are not regulated by FDA. LDTs neither constitute "medical devices" nor are commercially distributed among states -- both of which are requirements for FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act.

Rep. Joe Pitts pointed out that even if FDA did have the proper authority, the agency should follow the formal rulemaking process that such a major shift in policy requires, rather than skirting the law by issuing a guidance document. The American public MUST have a voice in policies that will have a profound impact on the quality of their health.

Accordingly, I am writing to ask your agency to clarify your regulatory authority to regulate LDTs, and to remind you that even if you do have the authority to proceed, you really ought to follow a formal rulemaking procedure so the public can have a say in the matter, instead of skirting the law by issuing a guidance document.

Sincerely,
[Your Name]
[Your Address]
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[Your Email]