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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 package and was widely expected to pass. However, some lawmakers are getting cold feet about drug pricing provisions within the Senate’s version of the bill and have pressed to strip the bill back to basics

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