Late on Friday, November 20, the Trump Administration issued two sweeping and controversial final rules regarding prescription drug prices. The details of these rules can be viewed in the 'deep dive' section below.

On Tuesday, November 17, President-elect Joe Biden announced members of his White House senior staff. The list includes seven campaign aides, as well as advisers who have held long-standing relationships with the President-elect. The General Services Administration still has not ascertained that Biden has won the election, hampering the Transition’s ability to coordinate on key issues, including the pandemic. On Thursday, Energy and Commerce Chairman Frank Pallone (D-NJ) wrote to President Trump urging him to begin the presidential transfer of power for the COVID-19 response.

On Monday, Moderna announced that its coronavirus vaccine is 94.5% effective at preventing the virus, based on its study of more than 30,000 participants. On Wednesday, the other leading vaccine producer, Pfizer, announced that it had reached its final safety goal, finding its coronavirus vaccine 95% effective at protecting against the virus. Pfizer submitted an application to the FDA for (Emergency Use Authorization) EUA on Friday.

The FDA announced its issuance of an EUA for the first COVID-19 test for self-testing at home. The single-use, disposable test from Lucira Health has been created to detect the novel coronavirus SARS-CoV-2 with a nasal swab. Results from the test will be available within 30 minutes or less, and the test can be used by individuals aged 14 or older. The test will likely be available by prescription across the nation in the spring of 2021.

On Friday, November 20, the Trump Administration issued two controversial regulations intended to lower prescription drug prices for Americans. The first rule announced finalizes a proposal based on the President’s July 24, 2020 Executive Order on "Lowering Prices for Patients by Eliminating Kickbacks to Middlemen.” The final rule will “exclud[e] rebates on prescription drugs paid by manufacturers to pharmacy benefit managers (PBMs) and Part D plans from safe harbor protection under the Anti-Kickback Statute (AKS).” Additionally, the rule creates a new safe harbor protection for fixed-fee services arrangements between manufacturers and PBMs. Essentially, the rule would require drugmakers to give rebates for brand name drugs directly to Medicare beneficiaries. Both the Congressional Budget Office and the CMS Office of Actuary previously estimated that the rule would increase premiums and taxpayer costs.  Matt Eyles, CEO of AHIP, immediately issued a stinging rebuke to the final rule, stating “While pharma manufacturers would have you believe rebates are a problem and have pushed the Administration’s ‘rebate rule,’ time and time again, economists and analysts have found that the rule takes us in the wrong direction by increasing costs and premiums.” The final rule would go into effect on January 1, 2022.

The Trump Administration also moved forward to finalize the “most-favored nations rule.” Under this rule, Medicare would pay no more for a drug than the lowest price in other Organization for Economic Cooperation and Development (OECD) countries. This rule would go into effect on January 1, 2020. However, due to President Trump’s limited amount of time remaining in office, it is unclear whether these final rules will withstand expected legal challenges from the pharmaceutical industry and the incoming Biden Administration. Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Ways and Means Committee Chairman Richard E. Neal (D-MA) released a statement after President Trump announced the drug pricing measures on Friday, stating that “While the coronavirus surges across the country, President Trump is spending his twilight days in office pushing through half-baked proposals that will likely be struck down in court because he’s desperate to cover up his Administration’s failure to actually lower drug prices.”

On Tuesday, November 17, President-elect Joe Biden announced members of his White House senior staff. The list includes seven campaign aides, as well as advisers who have held long-standing relationships with the President-elect. Many of those chosen have diverse backgrounds and robust experience in their respective fields. For example, Mike Donilon, who served as the Chief Strategist for the Biden-Harris campaign, will be the President-elect’s Senior Advisor. Jen O’Malley Dillon, who served as the Campaign Manager, will be the Deputy Chief of Staff. Anthony Bernal, who served as Chief of Staff to Dr. Jill Biden during the campaign, will now be Dr. Biden’s Senior Adviser. The General Services Administration still has not ascertained that Biden has won the election, hampering the Transition’s ability to coordinate on key issues, including the pandemic. On Thursday, Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) wrote to President Trump urging him to stop “stonewalling” and begin the presidential transfer of power for the COVID-19 response. The full list of Biden’s White House senior staff can be found here.