On Wednesday evening, the House voted 392-28 under suspension of the rules to pass legislation (H.R. 7667) that reauthorizes the Food and Drug Administration (FDA) user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars through fiscal year 2027. The bipartisan legislation aims to improve the FDA’s review process for the safety and efficacy of medical products, strengthen the Accelerated Approval program, ensure that clinical trials are diverse, and reduce the cost of drugs by making it easier for generic competitors to enter the market. Next week, on Tuesday, June 14, the Senate HELP Committee will hold a markup on its FDA reauthorization bill, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348).

Also on Wednesday, the House voted 223-204 to pass the Protecting Our Kids Act (H.R. 7910), which is legislation that would make changes to federal firearms laws. Five Republicans, including Anthony Gonzalez (OH), Fred Upton (MI), Brian Fitzpatrick (PA), Adam Kinzinger (IL) and Chris Jacobs (NY) voted in favor of the legislation. Two Democrats, Jared Golden (ME) and Kurt Schrader (OR) voted against it. The bill would generally prohibit the sale or transfer of certain semiautomatic firearms to individuals who are under 21 years of age, establish new federal criminal offenses for gun trafficking, and establish a federal statutory framework to regulate ghost guns. The legislation is not expected to pass the Senate, but there have been ongoing bipartisan negotiations in the Senate on gun control legislation. On Thursday, Senator Ron Wyden (D-OR), a strong proponent of telehealth expansion and mental health care, told reporters that he is working to include tele-mental health coverage in the Senate’s proposed gun violence package. He said that “There’s an opportunity to tackle mental health in the next few weeks in a valuable way.”

The Department of Health and Human Services (HHS) announced that it would give states an additional year (through March 31, 2025) to utilize funding from the American Rescue Plan (ARP) to “enhance, expand, and strengthen home- and community-based services (HCBS)” for Medicaid beneficiaries. HHS said that the ARP funding will enable states to better address existing HCBS workforce and structural issues. Additional information can be found here.

To help our global health systems better respond to future pandemics and other public health emergencies, the Biden Administration announced new steps it will take to improve public health systems in the Americas. The Administration’s “Action Plan on Health and Resilience in the Americas” will help U.S. partners prepare for these public health threats, while also “expanding the equitable delivery of healthcare and public health services to remote, vulnerable, and marginalized populations.”

It was also reported this week that the Administration will redirect nearly $5 billion in existing COVID-19 funds so it can purchase new versions of the vaccines if they become available. The Administration may also repurpose another $5 billion in aid to purchase additional COVID-19 therapeutics. 

On Wednesday evening, the House voted 392-28 under suspension of the rules to pass legislation (H.R. 7667) that reauthorizes the Food and Drug Administration (FDA) user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars through fiscal year 2027. The bipartisan legislation aims to improve the FDA’s review process for the safety and efficacy of medical products, strengthen the Accelerated Approval program, ensure that clinical trials are diverse, and reduce the cost of drugs by making it easier for generic competitors to enter the market. Next week, on Tuesday, June 14, the Senate HELP Committee will hold a markup on its FDA reauthorization bill, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348). Among other differences, the Senate’s version does not include measures on clinical trial diversity and would make changes to how the FDA regulates diagnostic tests.

On Wednesday, the House voted 223-204 to pass the Protecting Our Kids Act (H.R. 7910), which is legislation that would make changes to federal firearms laws. Five Republicans, including Anthony Gonzalez (OH), Fred Upton (MI), Brian Fitzpatrick (PA), Adam Kinzinger (IL) and Chris Jacobs (NY) voted in favor of the legislation. Two Democrats, Jared Golden (ME) and Kurt Schrader (OR) voted against it. The bill would generally prohibit the sale or transfer of certain semiautomatic firearms to individuals who are under 21 years of age, establish new federal criminal offenses for gun trafficking, and establish a federal statutory framework to regulate ghost guns. The legislation is not expected to pass the Senate, but there have been ongoing bipartisan negotiations in the Senate on gun control legislation. Just this week, Senator John Cornyn (R-TX), the lead Republican negotiator on these talks, said, “I’m glad to say on this topic we are making steady progress. It is early in the process, but I’m optimistic about where things stand right now. I’m optimistic that we could pass a bill in the Senate, it can pass the House and it can get a signature by President Biden. It will become the law of the land.” On Thursday, Senator Ron Wyden (D-OR), a strong proponent of telehealth expansion and mental health care, told reporters that he is working to include tele-mental health coverage in the Senate’s proposed gun violence package. He said that “There’s an opportunity to tackle mental health in the next few weeks in a valuable way.”

Late last week, the Department of Health and Human Services (HHS) announced that it would give states an additional year (through March 31, 2025) to utilize funding from the American Rescue Plan (ARP) to “enhance, expand, and strengthen home- and community-based services (HCBS)” for Medicaid beneficiaries. HHS said that the ARP funding will enable states to better address existing HCBS workforce and structural issues. Medicaid is the primary funder of HCBS nationally, and the ARP provided states with a temporary 10 percentage point increase to the federal medical assistance percentage (FMAP) for certain Medicaid HCBS expenditures, an estimated $12.7 billion. Additional information can be found here.

HHS will devote an additional $15 million to help prevent and treat substance misuse in rural communities. With this additional $15 million investment, HHS has devoted approximately $400 million to the Rural Communities Opioid Response Program (RCORP) initiative, which is a multi-year initiative aimed at reducing drug-related deaths in high-risk rural communities. A list of the grant awardees can be found here.

Biden-⁠Harris Administration Announces Action on COVID-⁠19 Pandemic Response and Improving Health Systems and Health Security in the Americas

To help our global health systems better respond to future pandemics and other public health emergencies, the Biden Administration announced new steps it will take to improve public health systems in the Americas. The Administration’s “Action Plan on Health and Resilience in the Americas” will help U.S. partners prepare for these public health threats, while also “expanding the equitable delivery of healthcare and public health services to remote, vulnerable, and marginalized populations.” The Administration plans to strengthen the health care workforce by partnering with the Pan American Health Organization (PAHO) to launch the Americas Health Corps, Fuerza de Salud de las Americas, which will train 500,000 public health, health science, and medical professionals throughout the region within five years. It was also reported this week that the Administration will redirect nearly $5 billion in existing COVID-19 funds so it can purchase new versions of the vaccines if they become available. The Administration may also repurpose another $5 billion in aid to purchase additional COVID-19 therapeutics. 

Senate Committee on Health, Education, Labor, and Pensions markup to consider S.4348, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, S.958, to amend the Public Health Service Act to expand the allowable use criteria for new access points grants for community health centers, and other pending calendar business.

Tuesday, June 14 at 10:00 AM ET

Full Committee Hearing: "An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning."

Thursday, June 16 at 9:30 AM ET

Select Subcommittee on the Coronavirus Crisis Hearing: Hybrid Hearing on "Examining Federal Efforts to Prevent, Detect, and Prosecute Pandemic Relief Fraud to Safeguard Funds for All Eligible Americans"

Tuesday, June 14 at 10:00 AM ET