The Honorable Patty Murray
Chair
Senate Health, Education, Labor & Pensions Committee
Washington, DC 20510
The Honorable Richard Burr
Ranking Member
Senate Health, Education, Labor & Pensions Committee
Washington, DC 20510
The Honorable Frank Pallone
Chair
House Energy & Commerce Committee
Washington, DC 20515
The Honorable Cathy McMorris Rodgers
Ranking Member
House Energy & Commerce Committee
Washington, DC 20515
Dear Chair Murray, Ranking Member Burr, Chair Pallone, and Ranking Member Rodgers:
We are writing to express our strong support for your bipartisan support for the VALID Act earlier this year, and to urge you to include it in the Omnibus Spending bill with a few small improvements. Our concern is that women and men who are at high risk of breast cancer or other types of cancer are not currently able to have confidence that genetic tests used for screening and diagnosis are accurate. Our members were shocked to learn that the FDA only regulates diagnostic tests sold by companies, not those sold by laboratories. We have many examples of patients who have been terribly harmed when lab-developed diagnostic tests that were widely sold have been dangerously inaccurate. There are currently approximately 100,000 different lab developed tests that would be grandfathered under the current bill language, and none of them would be required to submit evidence now or in the future to prove that their tests are accurate. Even the highest risk lab developed tests that are currently being sold could continue to be sold without any restrictions, and it is unclear if serious adverse events caused by inaccurate tests would be reported to the FDA. That is unacceptable to us as patient-centered organizations.
Your constituents deserve better. In addition to the extensive grandfathering, the bill would categorize lab-developed tests as low, moderate, or high-risk. Low-risk would be essentially unregulated, moderate risk would require some evidence but not be tested for accuracy (similar to the 510(k) review process). As you know, the 510(k) pathway is used to review approximately 95% of all medical devices, including most implanted devices, and it has been strongly criticized by physicians, patients, and public health experts because many of those devices are high risk, not moderate risk as the FDA claims.
As described in the current VALID provisions in the bill, only the highest risk devices would be required to provide clear evidence of accuracy, and the definition of high risk is unclear and based on the FDA’s track record is likely to exclude many tests that could cause irreparable harm, such as genetic tests that are used to inform people that they are at very high risk of breast cancer, ovarian cancer, stomach cancer, and other very serious diseases. Since many patients who are told that they tested positive for these genetic mutations have those important bodily organs surgically removed, those genetic tests should be considered high-risk. It would be equally tragic for a person to have an organ unnecessarily removed due to an inaccurate positive test result, or for a person to be incorrectly told they did not have a life-threatening genetic mutation, due to a false test negative result. Although we are focusing on breast cancer in this letter, it is well-known that most prenatal genetic testing is inaccurate, thus resulting in terminating wanted pregnancies because they were erroneously told their baby had a fatal birth defect. For that reason we strongly urge you to include genetic testing in the definition of “high risk” tests in the bill, and not allow grandfathering of high risk tests.
In addition to these shortcomings, we are concerned that academic medical centers are lobbying to be excluded from FDA regulation. While academic medical centers have an important role to play in U.S. healthcare, their tests are not monitored by the FDA, CMS, or any other independent entity to ensure they are accurate. As a result, there are clear examples of tests that were dangerously inaccurate. Any exemption for academic medical centers’ lab-developed tests should be extremely narrow, to target tests used for individuals, not for large numbers of patients. High-risk tests should always be regulated.
In conclusion, we strongly recommend including an improved version of the VALID Act, as described above, in the Omnibus bill, in order to better protect patients and consumers from inaccurate and unreliable lab-developed tests.
SINCERELY,
Breast Implant Safety Alliance
Cancer Prevention and Treatment Fund
National Women’s Health Network
Not Putting on a Shirt
Our Bodies Ourselves
Patient Safety Action Network
USA Patient Network
Washington Advocates for Patient Safety
WoodyMatters
Cc: Members of Senate Health, Education, Labor, and Pension Committee and Members of Energy & Commerce Health Subcommittee