COVID-19 Relief Bill Passes House, Heads to Senate for Reconciliation Process

In a 219-212 vote along party lines on Saturday, the House of Representatives passed the massive $1.9 trillion COVID-19 relief bill that includes $500 million in extra funding for the FDA and the elimination of Medicaid drug pricing rebate caps starting in 2023.

The one-time appropriation of $500 million would represent almost a 16 percent increase in the agency’s fiscal 2021 funding, which has remained essentially flat for several years.

The American Rescue Plan Act of 2021 (H.R. 1319) stipulates that the new money is to be used to bolster the FDA’s postmarket surveillance and inspections activities of COVID-19 vaccines and therapeutics, including those targeting coronavirus variants, and assist in the monitoring of potential shortages of COVID-19 products, among other regulatory activities.

In addition, the bill’s elimination of Medicaid drug rebate caps starting in 2023 would enable states to demand larger discounts when negotiating drug prices. The bill also calls for including COVID-19 vaccines and treatments in the Medicaid drug rebate program for covered outpatient drugs.

The House’s passage means the Senate can take up consideration of the bill this week, through the budget reconciliation process which requires only a simple majority of 51 votes to clear it. Democrats are seeking to have the bill on President Biden’s desk before March 14, when  COVID-19 supplemental unemployment benefits are set to lapse.

Read the full text of H.R. 1319 here: www.fdanews.com/02-28-21-Bills.pdf. ― Jason Scott