Advocacy - Lab Advocate
On November 5th, Republican nominee, former President Donald Trump, defeated Democratic nominee and current Vice-President, Kamala Harris, to become the next President of the United States. President-elect Trump is only the second person in American history to win non-consecutive terms to our nation’s highest office. The first was Democrat Grover Cleveland, who was elected President in 1884 and 1892. Trump has also won a majority of the popular vote, the first Republican to do so since George W. Bush in 2004, and received 312 electoral votes, including those from all seven of the so called ‘swing’ states.
Along with winning the presidency, the Grand Old Party (GOP) took control of the Senate and appears to have retained the House of Representatives, albeit by a narrow margin. The outcome of this context continues a trend dating back to 1992 that every president, in winning election as a member of the out-party, has taken office with a unified government to advance their political agenda. Over the next several weeks, the incoming President will pick his cabinet, including key health areas, such as the Department of Health and Human Services (HHS), the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA).
One area that may be affected by the changeover in government is regulation of laboratory developed tests (LDTs). In November 2016, the FDA withdrew its draft LDT guidance in the aftermath of the Republican electoral victory. The expectation was that the new administration and Congress would oppose the measure. During the President Trump’s first term, HHS issued an internal memorandum questioning whether the FDA had legal authority to oversee LDTs. Given the President-elect’s interest in reducing regulatory barriers and spurring innovation, the May 6th FDA LDT rule is likely to be scrutinized by the incoming administration.
Similarly, with the GOP takeover of the Upper Chamber, Senator Bill Cassidy (R-LA), is expected to replace Senator Bernie Sanders (D-VT) as the Chair of the Health, Education, Labor, & Pensions Committee, which has authority over LDTs. Senator Cassidy has long questioned whether the FDA has the authority or ability to regulate LDTs and has been willing to listen to laboratory community concerns about the FDA rule. Expect the Louisiana Senator to take a balanced, bi-partisan approach to addressing this issue which could involve different approaches to medical devices and CLIA modernization reform.
On the House side, Rep. Cathy McMorris Rodgers, Chair of the influential Energy and Commerce (E&C) Committee, and a long-time opponent of FDA oversight of LDTs, has retired. Rep. Brett Guthrie (R-KY), Chair of the E&C Subcommittee on Health, and also an opponent of the FDA rule, is seeking the position. The Republicans will select her replacement in the coming weeks.
Much of the Trump health agenda remains ill-defined. His priorities will become clearer in the coming weeks as he further spells out his legislative agenda and identifies his cabinet choices.
ADLM will post additional information on these developments as the new Congress and administration take shape.