Congress

Former FDA chief Mark McClellan says the Biden administration should consider making FDA an independent agency, separate from HHS, and he asserts the discussion should be a priority for Congress and the administration in 2021 due to concerns the Trump White House exerted political pressure over FDA’s COVID-19 decisions.

The Alliance for a Stronger FDA says a fiscal 2021 omnibus spending bill, instead of another continuous resolution, would be good news for FDA as it would likely give the agency an increase of around $40 million over fiscal 2020 levels, whereas if Congress signs another continuing resolution it would leave FDA with the same funding levels as fiscal 2020.

Bipartisan bills calling for generic drug labeling updates, an end to gaming of certain orphan drug exclusivity provisions and an updated list of major allergens are among 10 health care measures that were passed by the House on Tuesday (Nov. 17).

Device industry lawyers believe the new session of Congress will try to push forward legislation giving FDA regulatory authority over laboratory-developed tests, coming after the Trump HHS made headlines in August by unexpectedly announcing FDA lacked legal authority to regulate LDTs, including COVID-19 tests developed by labs.

President-elect Joe Biden’s call for face mask mandates has emerged as a central part of his COVID-19 transition plan, but he’s likely to face challenges if he chooses to pursue a national mandate, particularly as the Senate could remain Republican-controlled.

Whether President-elect Joe Biden will have to contend with a divided Congress will not be clear until Jan. 5, when both of Georgia’s Senate races head into runoff elections. With Republicans lined up to win other outstanding Senate races as of Saturday (Nov. 7), Democrats’ hopes of taking razor-thin control of the Senate appear to hinge on the two Georgia races. Until Senate leadership is cemented, it’s also unclear which party will control the Senate health, Appropriations and Finance committees that drive key health care policies.

Former FDA officials predict that FDA chief Stephen Hahn will be out as commissioner once presumptive President-elect Joe Biden takes office in January, even though Hahn fell out of favor with President Donald Trump for allowing FDA officials to move ahead with stricter COVID-19 vaccine emergency authorization criteria. While Congress likely would make it a priority to confirm a new commissioner, most of the agency’s COVID-19 response could be carried out in the meantime by career staff and scientists, the former officials say.

House appropriators might get the chance to rethink funding priorities for FDA, especially as the House Appropriations Committee, which will still be led by Democrats, faces leadership changes and appropriators face the possibility of having to reconsider a previously House-passed fiscal 2021 funding bill.

Although Democrats retained control of the House Tuesday (Nov. 3), the House Appropriations Committee will look different in 2021 as several committee members will retire at the end of the year, including Chair Rep. Nita Lowey (D-NY), which will leave the leadership seat vacant along with five additional open slots