What Is the Issue?
There are ongoing legislative efforts to extend Food and Drug Administration (FDA) oversight to laboratory developed tests (LDTs). Supporters of the Verifying Accurate Leading-edge IVCT Development (VALID) Act—the bill that would give the agency oversight of LDTs—are seeking to include it in the Medical Device User Fee Amendments (MDUFA) agreement that will soon be considered by Congress. AACC strongly opposes this initiative.
While AACC is supportive of medical device reform, MDUFA should not be linked to VALID. If enacted, VALID will have significant unintended consequences on the ability of hospitals and community laboratories to provide the testing needed by clinicians to care for their patients. Before taking up this bill, Congress should therefore have a thorough, public discussion of VALID that’s independent of MDUFA.
Send a pre-written letter to your legislators about this today.
AACC has held meetings with congressional staff on the two panels responsible for approving MDUFA: the Senate Health, Education, Labor, and Pensions (HELP) and House Energy and Commerce committees. In particular, we are focusing our attention on Senate HELP, which is taking the lead on the issue, and have met with 17 of the 22 Senate HELP offices. AACC’s message of dual regulation and limits on patient access to care has resonated with many of these offices.
AACC and its partners have developed and sent targeted letters to the two aforementioned congressional committees urging legislators to keep VALID out of MDUFA. The first letter included 19 professional groups, including AACC and the AMA, and was sent in late February. A second letter from 38 healthcare entities, including ARUP and TriCore, made a similar appeal.
AACC and its allies held an in-person briefing on April 4, sponsored by Senator Rand Paul (R-KY), for all congressional staff highlighting the importance of LDTs and the patient harm that could result from excessive federal oversight. Dr. Dietzen represented AACC on the panel. More than 30 congressional staffers were in attendance.
AACC has initiated a grassroots campaign urging healthcare professionals to send pre-written messages to their legislators in favor of separating VALID from MDUFA. The campaign coincides with plans by the Senate HELP committee to vote on MDUFA by the end of May. Thus, AACC and its allies are pulling out all stops to prevent this from occurring. The association will continue to use broadcast emails, social media, the Artery, and its web page to promote this campaign.