Expect FDA Diagnostics-Reform Bill Passage In 2019, Rep. DeGette Says
Passage of a US FDA diagnostics reform bill is one priority for the US House Energy and Commerce Committee in 2019, said cosponsor and committee member Rep. Diana Degette, D-Colo.
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FDA is hoping Congress might take up proposed legislation governing the regulation of diagnostic tests produced in laboratories in 2023. That will make it a full decade of stalemate since FDA outlined a framework to address the new reality of personalized medicine.
After failing to gain traction last year, a couple of US lawmakers are hoping to garner support for a pair of bills that would require certain diagnostic tests to be regulated by the US FDA that are currently outside the scope of the agency’s oversight. The bills are intended to be a solution to concerns that certain tests do not require adequate proof of safety and effectiveness, which could lead to misdiagnoses.
The number of direct-to-consumer advertisements for molecular-based tests rose exponentially from 1997 to 2016, according to a medical marketing analysis released earlier this month in the Journal of the American Medical Association. Simultaneously, laboratory test manufacturers increased spending on ads and direct spending on physicians who work with the tests from $75.4m to $82.6m.