Diagnostics companies and trade groups are urging lawmakers to enact reforms as part of the user-fee reauthorization process.
The request, in a July 20 letter signed by test makers including AdvaMedDx, Abbott Laboratories and Roche, follows the divergence of the texts passed by committees in the House and the Senate.
After several failed attempts to pass legislation to create a new regulatory framework for diagnostics, the Senate Committee on Health, Education, Labor and Pensions recently tried to get the proposals into law by incorporating the VALID Act into the Food and Drug Administration user-fee bill. However, the House version of the bill lacks the diagnostic reforms and, with time running out to reach an agreement, Sen. Richard Burr, R-NC, has proposed removing the diagnostic riders.
Burr’s proposal triggered a response from the industry. More than 40 organizations including Becton Dickinson, Qiagen and Roche have written to Burr and three other lawmakers to request the inclusion of the diagnostic reforms, arguing the proposal has “broad support from the stakeholder community” and was approved by the Senate committee on a bipartisan basis.
The reform proposals have proven contentious.The American Clinical Laboratory Association (ACLA), which represents Labcorp and Quest Diagnostics, said in May that the VALID Act “risks interrupting test availability” and has issues that must be addressed. ACLA is not a signatory of the recent letter to lawmakers.
