This Week in Washington: House Passes Inflation Reduction Act by a vote of 220-207
The Senate is in its Recess
Members Push FDA to Finalize Risk-Mitigation Strategy for Mifepristonea
On Aug. 3, Sens. Warren (D-MA), Hirano (D-HI) and Baldwin (D-WI) wrote a letter asking the FDA to quickly finalize updates to the risk-mitigation strategy for mifepristone that would make the medication abortion drug more accessible in the wake of the Supreme Court’s reversal of Roe v. Wade, and to also approve the drug for miscarriage procedures.
The FDA announced in December 2021 a series of risk mitigation strategies but has yet to officially approve them. The letter requests the FDA to expedite its review of the manufacturers’ plans to certify pharmacies and to finalize the updated REMS well before the 180-day statutory deadline.
FDA has said it is starting a certification process for pharmacies, including mail order pharmacies, to dispense mifepristone but has not finalized it yet, according to a policy professional who is involved with the Protecting Access to Medication Abortion Act.
The senators also ask FDA to review the remaining pieces of the REMS to determine whether any restrictions placed on the prescription and distribution of mifepristone, including patient consent forms, are medically unnecessary.
In addition, the senators ask FDA to work toward adding a miscarriage indication to the mifepristone with misoprostol label.
House Passes Inflation Reduction Act
Following the Senate passage of the Inflation Reduction Act (budget reconciliation), the House returned from its recess to pass the legislation. The rule by which the House considered the legislation did not permit any amendments. In addition to including Medicare negotiation of drug prices, and an extension of the ACA credits, the legislation would require adults enrolled in Medicare, Medicaid or CHIP to receive all vaccines by the Advisory Committee on Immunization Practices without cost sharing. This means Medicare beneficiaries would not have cost sharing for adult vaccine administration covered under Medicare Part D beginning in 2023.
Text of the legislation can be found https://rules.house.gov/bill/117/hr-5376-sa
In addition, prior to Senate consideration the Congressional Budget Office (CBO) released an estimate of the bill and answered other questions in a report that can be found at https://www.cbo.gov/publication/58366
Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.