Advocacy - Lab Advocate
For the past year, the Senate Health, Education, Labor and Pensions (HELP) committee has been working on a comprehensive ‘Innovation’ package of healthcare reforms to streamline the regulatory processes for developing and adopting newer medical technologies. After months of internal discussions, it appears the committee cannot reach agreement.
One obstacle to completing work on the package has been differences of opinion between HELP Republicans and Democrats on how to address Food and Drug Administration (FDA) oversight of laboratory developed tests (LDTs). Many Republicans prefer that LDTs be regulated within the current CLIA model, whereas the Democrats are backing enhanced FDA involvement. AACC supports the CLIA-centric approach.
In response to this divide, the Chair of the panel is proposing separate votes on the key elements of the Innovation package. Among the issues likely to be considered include measures to advance precision medicine, provisions to assist new researchers in obtaining and retaining NIH grant funding, and reforms to streamline the FDA review process for rare diseases and new devices. AACC is already on record in support of precision medicine and the young researchers initiatives.
AACC will remain vigilant in tracking these bills, however. Legislators could amend the measures to include language promoting greater FDA oversight of LDTs. The Association will oppose such efforts and will continue to promote enhancements to CLIA to address concerns being raised by those seeking greater FDA involvement. Look for periodic updates on this evolving situation in future editions of the Lab Advocate.