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Janet Freeman-Daily is a writer, speaker, science geek and epatient with metastatic lung cancer. She uses her systems engineering background to translate the experience and science of lung cancer treatment and research into language other patients can understand. She comoderates the Lung Cancer Social Media (#LSCM) Chat on Twitter and blogs at www.grayconnections.wordpress.com.
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Call to Action: Proposed FDA Regulations Could Limit Cancer Patient Access to Life-Saving Therapies

The FDA's framework for regulating lab developed tests could keep some patients from receiving validated diagnostic tests and targeted treatments like mine.
PUBLISHED: FEBRUARY 01, 2015
Talk about this article with other patients, caregivers, and advocates in the General Discussions CURE discussion group.
As posted in a recent CURE article, the US Food and Drug Administration (FDA) has proposed draft regulations titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).”  The FDA should withdraw this proposed framework because it could limit cancer patient access to potentially life-saving therapies.

Metastatic cancer patients have waited years for the hope that targeted therapies and genomic testing are now giving us. Don't let the FDA throttle our hope. Knowledge of cancer genomics and proteins is evolving faster than government regulation can move.

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.

Please sign the change.org petition at http://chn.ge/1uN2e2Z, and ask your friends and family to sign. If you or a loved one has benefited from molecular or genomic testing, please say so in the comments.  The petition and its comments will be submitted to the FDA as an official comment. The more signatures we have, the stronger our voice will be.

Here is a specific example of patient harm these proposed regulations might cause, taken from my own journey with metastatic ROS1-positive non-small lung cancer (NSCLC). 

I live near Seattle. Because I was able to send my slides to University of Colorado for ROS1 testing, and my slides tested positive for ROS1, I was able to take crizotinib and achieve two years (and counting) of No Evidence of Disease. LDTs for ROS1 have been validated by medical research and have given many patients months or years of extra time.

Under the proposed regulations, some patients might have to travel to a distant or out-of-network medical facility to get the existing ROS1 test and receive treatment for their ROS1 cancer. In addition, some labs might stop offering the test because of the lengthy and cost-prohibitive process to obtain FDA approval. A medically validated test that is currently saving lives may become inaccessible to future lung cancer patients. The proposed FDA regulations would have effectively interfered with the practice of medicine.

Talk about this article with other patients, caregivers, and advocates in the General Discussions CURE discussion group.
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