The Food and Drug Administration has just announced that it plans to begin a new level of oversight for laboratory developed tests (LDTs). I, and many others with cancer, think this is a terrible idea.
But wait, you say, isn't FDA oversight a good thing? We all want to stay safe!
Absolutely! I want to know that I am safe, and oversight is necessary and beneficial!
However, there already is oversight. These laboratories currently undergo a certification process by the Centers for Medicare and Medicaid services, as well as other accreditation agencies. This new FDA regulation adds an additional, time-consuming hoop that will slow down testing of things like cancer mutations.
Those of us with metastatic cancer don't have years to wait for FDA approval of these genetic tests.
I have a rare mutation that drives my cancer's growth, and I am currently living well on a daily pill developed to target that mutation. When my lung cancer finds a way around this pill - which it inevitably will - I will be counting on these laboratories to test that cancer growth and find a new treatment for me. Cancer moves fast; we need to move faster.
Our understanding of cancer is developing at an incredible rate, and laboratories need the freedom to react quickly, developing and tweaking these tests without having their hands tied by slow, unnecessary extra oversights.
Fellow stage 4 lung cancer patient Janet Freeman-Daily wrote eloquently about this proposed legislation: "Of course, we all want LDTs to be as validated, accurate and clinically relevant as possible. However, we also want the laboratories where these clinical testing services are performed to be able to exercise the flexibility, innovation and medical judgment necessary for good outcomes in thousands of cancer patients. This isn’t possible with the proposed FDA regulations."
Have you had genetic testing? Has you tumor been tested for mutations? This new legislation could stand in the way of that happening for you or others in the future.
If you have cancer, this impacts you.
If a family member has cancer, this is important.
Please take a moment to sign the petition, and encourage those who care about you to do the same.
(Still not sure? At least click the link below and read more about the reasoning behind this petition. It could change the course of your life.)
Tell the FDA to withdraw its proposed regulations for laboratory developed tests (LDTs). These regulations could limit patient access to life-saving tests and therapies.
The link: http://chn.ge/1uN2e2Z
Originally posted at: http://www.curetoday.com/community/tori-tomalia/2015/02/when-cancer-gets-political