Summary
This week, House leaders plan to vote on a standalone $15.6 billion COVID supplemental package (H.R. 7007) that was pulled from the fiscal year (FY) 2022 appropriations omnibus due to pushback from some Democrats over the offsets. Nearly identical to the original version, this new bill includes $9.85 billion to procure therapeutics and vaccines, $750 million to develop vaccines against future variants, and $5 billion for global health and humanitarian efforts. The major difference is that the new COVID bill is not completely offset, because it does not rescind $7 billion in unspent Coronavirus State and Local Fiscal Recovery Funds. Even with this change, it is unclear if the House and Senate have the votes to pass the package.
In addition, committees in both chambers will work on health-related legislative priorities, including pandemic preparedness, prescription drugs, and public health. Tomorrow, the Senate Health, Education, Labor, and Pensions Committee will mark up the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act, S. 3799) – bipartisan legislation focused on strengthening and modernizing federal public health and medical preparedness and response systems and programs introduced by Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) (WHG summary). The introduced bill incorporates feedback on the discussion draft unveiled in January and includes new provisions to:
- Improve biosafety and biosecurity, focusing on laboratories and research.
- Address undue foreign influence in biomedical research by requiring National Institutes of Health (NIH) extramural researchers to disclose participation in foreign talent programs, as well as requiring the Health and Human Services (HHS) Secretary to develop a risk framework for assessing and managing national security risks for biomedical research involving human genomic information.
- Bolster the public health and allied health workforces by increasing educational opportunities in physical therapy, occupational therapy, respiratory therapy, audiology, and speech-language pathology professions.
- Direct HHS to ensure coordination and collaboration between relevant Federal departments and agencies related to the safety and availability of the blood supply.
- Authorize the Centers for Disease Control and Prevention (CDC) Director to appoint directors of individual centers at CDC and regularly review leadership within the agency; and
- Establish the Office of Pandemic Preparedness and Response Policy (OPPRP) in the White House to advise on pandemic preparedness and response policy and support coordination and communication within the federal government.
On Wednesday, the Senate Finance Committee will hold a hearing on lowering prescription drug prices in Medicare. The hearing appears to be an attempt to advance prescription drug pricing reform through regular order. We anticipate lawmakers will discuss drug pricing provisions contained in the Build Back Better Act, such as negotiations, inflation rebates, and Part D redesign. Of note, former Senate Finance Chairman Sen. Charles Grassley (R-IA) issued a letter last week urging the Biden Administrator to support passage of the Prescription Drug Pricing Reduction Act – bipartisan legislation from the 116th Congress that included some of the policies likely up for discussion in this week’s hearing.
On Thursday, the House Energy and Commerce Subcommittee on Health will hold a hearing to discuss an array of bills “intended to encourage the development of new cures and treatments, strengthen regulatory oversight at FDA, including the Accelerated Approval Program, and ensure clinical trials reflect the diversity of all American patients,” said E&C Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna Eshoo (D-CA).
Key bills to be discussed include authorizing bills to establish Advanced Research Projects Agency for Health (ARPA-H), which was funded at $1 billion in the appropriations omnibus:
- Cures 2.0 Act (H.R. 6000), introduced by Reps. Diana DeGette (D-CO) and Fred Upton (R-MI), would authorize the creation of ARPA-H within the National Institutes of Health (NIH), permanently expand a number of telehealth flexibilities enacted during the ongoing COVID-19 public health emergency, expand public health capacity and improve pandemic preparedness, increase the use of real-world evidence and novel trial designs in the medical device and drug product development process, and improve the experience of patients and caregivers (WHG summary).
- Advanced Research Project Agency-Health Act (H.R. 5585), introduced by Health Subcommittee Chairwoman Eshoo, would authorize the creation of ARPA-H within HHS.
The Health Committee will also discuss the Accelerated Approval Integrity Act of 2022 (H.R. 6963), introduced by Chairman Pallone, which would direct FDA to impose stricter requirements for its Accelerated Approval Program (AAP) (WHG summary). Overall, the bill requires the Secretary of the Department of Health and Human Services (HHS) and sponsors of AAP products to enter into agreements prior to approval that describe the how to conduct the required post-approval studies, as well as requiring these studies to be underway prior to approval. Pursuant to the agreement, sponsors must also report on their progress to study completion every 90 days. Finally, the bill outlines the instances in which the Secretary can withdraw accelerated approval or approval automatically expires, including failing to confirm clinical benefit.