This week in Washington: Infrastructure deal struck, but it still has a long road ahead to passage; Senate Budget Committee discussed draft resolution with health initiatives included.


Cures 2.0 Draft Released
On June 22, Reps. Diana DeGette and Frank Upton (R-MI) released draft legislation that would create an Advanced Research Projects Agency for Health (ARPA-H) and authorize more than $6.5 billion to run the agency. The draft bill also aims to make innovative health care technologies more available, increase diversity in clinical trials, require the FDA to expand the collection of real-world evidence, provide training programs for caregivers, provide patients greater access to health information and increase access to telehealth services for patients under government-based health programs. A summary of the draft legislation can be found here.

House Appropriations Subcommittee Approves Bill to Increase FDA Funding
On June 25, the House Appropriations Committee Subcommittee on Agriculture, Rural Development, and the Food and Drug Administration (FDA) approved legislation that would allocate $3.47 billion in federal spending to the FDA in fiscal year 2022, a $257 million increase from 2021. The legislation would give the FDA’s drug center $2.1 billion, with a minimum of $8.5 million designated for surprise foreign inspection pilots. In addition, the Center for Biologics Evaluation and Research would receive $454 million, and the medical devices center would receive $652 million. The bill will be sent on to a full committee vote next week. A draft of the appropriations legislation can be found here.

House Panels Request Information about J&J and AstraZeneca’s Response to Emergent’s Response to Contaminated COVID-19 Vaccines
On June 22, House Oversight Chair Carolyn Maloney (D-NY) and House Coronavirus Crisis Chair Jim Clyburn (D-SC) wrote to the chief executives of AstraZeneca and Johnson & Johnson (J&J), asking them to explain their agreements with Emergent BioSolutions in an effort to better understand how the contractor contaminated millions of COVID-19 vaccines. In the letters, Reps. Maloney and Clyburn state that the Baltimore contract manufacturer Emergent was warned multiple times about manufacturing problems and insufficient controls at the facility but failed to act. Manufacturing of the J&J COVID-19 vaccine at the Emergent facility was halted by the FDA in April after ingredients from the AstraZeneca vaccine contaminated a batch of the J&J vaccine. Emergent had to destroy 85 million doses as a result. The committee chairs instructed J&J and AstraZeneca to respond to the letters by July 6. The letter to Dr. Pascal Soriot, AstraZeneca CEO, can be found here. The letter to Alex Gorsky, J&J CEO, can be found here.


Senate Budget Draft Resolution Would Add to Medicare
A Senate Democratic discussion budget outline would result in a roughly $6 trillion package of gross spending increases that on net would add $3 trillion to deficits over the next decade. That’s far more than the roughly $850 billion in bigger deficits over 10 years that President Biden had proposed. Among the health care proposals included in the budget are the inclusion of new Medicare dental and vision benefits and dropping Medicare’s eligibility age to 60. In addition, the health care spending would be offset by $617 billion obtained through Medicare drug price negotiation authority and other drug pricing savings. A budget resolution is a broad outline of spending and taxing priorities and is not a law. Authorizing committees would have to pass legislation to actually enact the new programs envisioned in the resolution.

Sen. Wyden Releases Principles for Drug Pricing Reform
On June 22, Senate Finance Committee Chair Ron Wyden (D-OR) released a document outlining a proposal to reduce prescription drug prices. The proposal includes provisions that would allow Medicare to negotiate with pharmaceutical companies and apply lower prices to private and public insurance programs. In the document, Sen. Wyden’s plan also includes measures to block a Trump-era ban on rebates and protect small biotechnology companies. Sen. Wyden’s Principles for Drug Pricing Reform document can be found here.

Better Care Better Jobs Act Introduced
On June 24, a group of Democratic senators introduced the Better Care Better Jobs Act, which would increase Medicaid funding for home and community-based services (HCBS) in line with President Biden’s vision laid out in the American Rescue Plan. The bill was introduced by Sens. Bob Casey (D-PA), Ron Wyden (D-OR), Chuck Schumer (D-NY), Patty Murray (D-WA), Tammy Duckworth (D-IL), Maggie Hassan (D-NH) and Sherrod Brown (D-OH). A House companion bill was introduced by Reps. Debbie Dingell (D-MI), Frank Pallone (D-NJ), Jan Schakowsky (D-IL) and Doris Matsui (D-CA). The bill can be found here.

Bipartisan VALID Act Introduced
On June 24, the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 was introduced in the Senate by Sens. Richard Burr (R-NC) and Michael Bennet (D-CO) and in the House by Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN). The bill, which was first introduced in 2020, would create a new framework for regulating diagnostic tests. The 2021 version of the bill would also remove pre-approval requirements during public health emergencies.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.