On May 24, 2012, the U.S. Senate passed the Food and Drug Safety and Innovation Act, which reauthorizes funding for activities related to the drug and device approval process at the U.S. Food and Drug Administration (FDA). The legislation also includes requirements and provisions for faster review of new and innovative therapies in order to allow patients to be able to access these therapies more quickly. The next step is for the U.S. House of Representatives to pass the bill, and then a final bill will go to the President for signature.

During debate on the Senate bill, Senator Mark Warner (D-VA) spoke on the necessity of finding ways to strengthen and improve the FDA’s review process of new and innovative diagnostic tests, including biomarkers. While biomarkers are not specifically addressed by the legislation, during his remarks, Senator Warner specifically cited preeclampsia as an example of why the country needs to move biomarkers forward and develop a better process for the FDA to work with industry. The following is a copy of the Senator’s remarks as recorded in the Congressional Record:

“Preeclampsia is a disorder that affects hundreds of thousands of pregnant women every year, which undiagnosed, can put a woman at risk for death and the fetus at risk of still-birth.

Doctors currently use a mix of imprecise signs and symptoms to diagnose it but often times such signs and symptoms are wrong. However, researchers have found a biomarker—a particular biological process or sign—that can accurately identify women with preeclampsia that are at risk for pregnancy complications.

Unfortunately, tests for novel biomarkers are taking five or more years to get approved by the FDA, delaying patients from receiving the benefits of more accurate diagnoses and treatments.

I was pleased that a recent commitment letter between the FDA and industry specifically mentions the FDA’s commitment to work together with industry to create a transitional IVD, or “T IVD” process for the development of tests for novel biomarkers.

I look forward to seeing how this T IVD process develops in discussions between FDA and industry and am interested in progress towards its implementation, which supports advances in the sciences and promotes access to these emerging diagnostics.

If reducing healthcare costs is a national priority, we need to act today. I encourage my colleagues to pass S. 3187 and allow the FDA to work more closely with the medical industry to safely bring new technologies to the marketplace.”

The Preeclampsia Foundation is engaging with industry and the federal government to ensure biomarkers for preeclampsia can be carefully considered and the barriers to movement can be understood and addressed. The Foundation is pleased to have Congressional attention focused on this issue.

 

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