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Health Industry Groups Press For Diagnostics Reform Bill

 
• By Elizabeth Orr

Almost 50 stakeholder groups have signed onto a letter to US Congressional leadership that asks lawmakers to pass the VALID Act, which would update the country’s approach to diagnostic test regulation. Congress needs to pass a user fee package this month to ensure full FDA funding.

US Capitol building, Washington DC (f11photo/Shutterstock.com)

Diagnostics industry companies, patient groups, [BB1]and trade associations are speaking up in the wake of last week’s news that US Food and Drug Administration user fee reauthorization legislation – which Congress must pass soon to maintain agency operations – might not include long-discussed diagnostic regulatory reforms.

The VALID (Verifying Accurate Leading-edge IVCT Development) Act, which would allow the FDA to regulate in vitro diagnostics, including lab-developed tests (LDTs), had been bundled into the Senate’s user fee...

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