What Happened, What You Missed: December 5-9


Report Calls for FDA to Break Up

The Food and Drug Administration (FDA) should be split up to address problems plaguing the agency’s food oversight arm, according to a new report by the Reagan-Udall Foundation.  The agency asked the Reagan-Udall Foundation to analyze its operations in the wake of the infant formula crisis earlier this year.  According to the report, flaws in the FDA’s leadership structure and poor communication among agency officials has resulted in the agency’s food safety operations being consistently underfunded, understaffed, and underprioritized.  The report also suggested a less drastic measure that would create a deputy commissioner position with authority for overseeing food.  Any move to split up the agency would require approval from Congress.

FDA Authorizes COVID-19 Boosters for Kids under 6

On December 8, the FDA approved bivalent COVID-19 booster shots from Pfizer and Moderna for children six months to six years of age.  The announcement comes as children’s hospitals across the country are at capacity for kids suffering from a range of respiratory illnesses, including COVID-19, respiratory syncytial virus (RSV), and the flu.  However, the rules on who can get a shot when differ depending on whether the initial vaccine regimen came from Pfizer or Moderna.  Children under age six who have completed Moderna’s two-dose regimen can get their bivalent booster if it’s been at least two months since their last shot, while children under six who received the first two doses of Pfizer’s three-dose regimen can use the new bivalent booster for their third shot.  However, children who received all three initial vaccine doses from Pfizer aren’t yet eligible for a booster shot.

ICER: Biggest Drug Price Increases Not Substantiated

According to a report by the Institute for Clinical and Economic Review (ICER), price increases among seven of the ten drugs in 2021, which saw the largest increases from the year prior, were not supported by clinical evidence.  Out of the $805 million increase in drug spending from 2020-2021, Bausch Health’s Xifaxan, an antibiotic drug for traveler’s diarrhea, saw the biggest increase of nearly $175 million in spending, while Johnson & Johnson’s schizophrenia drug Invega Sustenna and Amgen’s osteoporosis drug Prolia were second and third with respective spending increases of $170 million and $124 million.  According to ICER, the report is intended to inform policymakers and lawmakers on policies they can pursue to address high drug prices.  However, the report acknowledged that the impact of the Inflation Reduction Act’s Medicare drug price negotiation on commercial payers remains uncertain.

ACA Marketplace Enrollment Reaches 5 Million

Nearly 5.5 million individuals from November 1 to December 3 selected a 2023 health plan through the federally facilitated and state-based marketplaces, according to the Centers for Medicare and Medicaid Services (CMS).  Roughly 80% of enrollees renewed their health care coverage, while the rest were new enrollees.  33 states currently use the federal marketplace for the 2023 open enrollment period, which runs through January 15, 2023.  CMS also reported that state-based exchanges will automatically renew coverage for about 2.9 million residents nationwide.

Top Ways and Means Republicans Make Their Case for Chairmanship

With current Ways and Means Committee Ranking Member Kevin Brady (R-TX) set to retire soon with the end of the 117th Congress, three senior Republicans on the committee are making the case to succeed Brady and chair the committee in the next Congress.  As the Republican Steering Committee prepares to vote on who will get the chairman’s gavel in January, Rep. Vern Buchanan (R-FL) is touting his business background, Rep. Jason Smith (R-MO) is taking a populist approach while emphasizing his ties to working class voters, and Rep. Adrian Smith (R-NE) is presenting himself as a top policy expert.  Whoever is elected chairman will have the opportunity to shape health care policy, due to the committee’s jurisdiction on Medicare.

ICYMI: Representatives Vie for New House Offices

73 incoming House members were assigned their designated workspaces on Capitol Hill as a part of a biennial office lottery that took place late last week in the Cannon House Office Building.   While past lotteries followed the alphabetical order of members’ names, this year’s lottery was completely randomized.  The Rayburn House Office Building is usually seen as the most desirable office location, since the building is connected to the Capitol by the subway.

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