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Congress

November 24, 2020 | Daily News

With nursing homes in the Midwest seeing a 275% increase in COVID-19 cases since September, patient advocates say the holidays underscore the need to reduce community spread while the overall pandemic has exposed issues with staffing shortages and how facilities are paid.

November 23, 2020 | Daily News

The Trump administration must pause any efforts to cut off consumers’ Affordable Care Act subsidies for the 2021 plan year since IRS processing delays have resulted in Americans being wrongfully denied financial assistance, Democratic Sen. Mark Warner (VA) writes in a letter to IRS and CMS.

November 20, 2020 | Daily News

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.

November 20, 2020 | Daily News

As coronavirus cases top 170,000 a day, states and providers are looking at a potential omnibus spending bill -- or any other vehicle to keep the government funded -- to implement their COVID-19 relief wish lists, which largely consist of more money for providers and cash-strapped states, many of whom want to see the CARES Act spending deadline extended into next year so they can use funds they already have for vaccine distribution.

November 19, 2020 | Daily News

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.

November 17, 2020 | Daily News

The American Hospital Association, American Medical Association and American Nurses Association are pressing the Trump administration to quickly share real-time data on COVID-19 supplies and updates on response efforts with President-Elect Joe Biden’s transition team.

November 17, 2020 | Daily News

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).

November 12, 2020 | Daily News

House Minority Leader Kevin McCarthy (R-CA) told reporters Thursday (Nov. 12) he is waiting to see who will become the next House speaker before working across the aisle on another COVID-19 package.

November 11, 2020 | Daily News

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.

November 11, 2020 | Daily News

Leaders of the House Cannabis Caucus on Tuesday (Nov. 10) called for lawmakers to support passage of marijuana legislation after House Majority Leader Steny Hoyer (D-MD) said the House will vote in December on a bill that aims to remove marijuana from the Controlled Substances Act -- a move that would take authority away from the Drug Enforcement Administration and potentially put it at least partially into the hands of FDA.

November 10, 2020 | Daily News

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.

November 10, 2020 | Daily News

The Senate Appropriations Committee on Tuesday (Nov. 10) proposed giving FDA more than $3 billion in discretionary funding for fiscal 2021, a $40 million increase in base funding over fiscal 2020 levels.

November 07, 2020 | Daily News

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.

November 07, 2020 | Daily News

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. 

November 07, 2020 | Daily News

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.

November 05, 2020 | Daily News

Drug pricing legislation may be in for another couple years of slow progress due to the likelihood of a divided Congress, though the drug industry might still be targeted for offsets with one-off measures that don’t constitute comprehensive drug pricing bills.

November 05, 2020 | Daily News

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.

November 05, 2020 | Daily News

No matter the outcome of the election, the drug industry will be exposed to reforms that could hurt its profits as lawmakers seek offsets for the costly task of dealing with the wave of people losing insurance due to the pandemic and the more than 20 million people whose coverage could be disrupted if the Supreme Court strikes the Affordable Care Act this summer, lobbyists and analysts say.

November 04, 2020 | Daily News

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

November 04, 2020 | Daily News

House Energy & Commerce Committee members seeking re-election were largely successful Tuesday night (Nov. 3) with more than 40 lawmakers retaining their seats, but the committee’s overall makeup is still expected to change as 10 members did not run for another term.

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