Our newsletter reflects the focus of Akin’s cross-practice autonomous systems and advanced mobility team on developments in the regulatory, policy, trade, intellectual property, and cybersecurity and privacy spaces....more
8/14/2023
/ Airlines ,
Automation Systems ,
Aviation Industry ,
Clean Energy ,
Critical Infrastructure Sectors ,
Drones ,
Electric Vehicles ,
Federal Aviation Administration (FAA) ,
Innovative Technology ,
Motor Vehicles ,
National Emissions Standards ,
Unmanned Aircraft Systems
Our newsletter reflects the focus of Akin’s cross-practice autonomous systems and advanced mobility team on developments in the regulatory, policy, trade, intellectual property, and cybersecurity and privacy spaces....more
Our newsletter reflects the focus of Akin Gump’s cross-practice autonomous systems and advanced mobility team on developments in the regulatory, policy, trade, intellectual property, and cybersecurity and privacy spaces....more
Autonomous Akin brings you the latest news and developments regarding autonomous systems and advanced mobility so that you can keep a pulse on what is happening in government and industry that is impactful for your business....more
The Biden-Harris administration and Congress appear poised to continue focusing on drug pricing issues this year, most notably with the Centers for Medicare & Medicaid Services moving forward with implementation of the drug...more
The House and Senate convened this week to kick off the 118th Congress. Republicans control the House after four years of a Democratic majority. House Republicans have a very slim majority, with only 222 seats to the...more
1/12/2023
/ Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Congressional Budget Resolution ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Legislative Agendas ,
Medicare ,
Medicare Part B ,
Regulatory Agenda
In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more
On December 29, 2022, the President signed into law the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) as part of the Consolidated Appropriations Act, 2023 (P.L....more
Key Points -
The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data.
New price setting provisions built into the IRA...more
The Inflation Reduction Act (IRA), P.L. 117-169, which became law on August 16th, included some of the most consequential prescription drug pricing reforms ever passed by Congress. This week marked a pivotal milestone in the...more
On September 30, 2022, Congress enacted legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and biologics, medical devices, generic drugs and biosimilars (PDUFA,...more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation -
Key Points -
The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
On August 23, 2022, the United States Food and Drug Administration (FDA or the “Agency”) published the revised draft guidance “Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry” (the...more
Washington, D.C. is currently focused on a September continuing resolution (CR) to keep the federal government funded, but it is worth looking ahead to the broader health care horizon and the key Medicare issues that await...more
9/19/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Lame Duck Session ,
Legislative Agendas ,
Medicare ,
Mental Health ,
Substance Abuse ,
Telehealth ,
Telemedicine
Prompted by rising rates of overdose deaths, suicides and incidence of mental illness in at-risk populations, such as children, Congress has spent the better part of the year working in a bipartisan manner to develop and...more
9/8/2022
/ Biden Administration ,
Drug & Alcohol Abuse ,
Health Care Providers ,
Mental Health ,
New Legislation ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Public Safety ,
State and Local Government ,
Substance Abuse ,
Telehealth
On August 11, the U.S. Centers for Disease Control and Prevention (CDC) issued updated COVID-19 guidance “to help people better understand their risk, how to protect themselves and others, what actions to take if exposed to...more
8/25/2022
/ Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Employer Liability Issues ,
Employment Policies ,
Health and Safety ,
Infectious Diseases ,
National Institute of Allergy and Infectious Diseases (NIAID) ,
OSHA ,
Vaccinations ,
Workplace Safety
Today, President Biden signed the Inflation Reduction Act of 2022 (IRA) into law. The final IRA bill came together after more than 18 months of intra-party negotiations among Democrats about what legislative priorities to...more
The following alert provides a high level update to the August 4 Akin Gump comprehensive section-by-section report, which was published before the Senate vote-a-rama and final Senate passage. This update is being published...more
Sens. Joe Manchin (D-WV) and Chuck Schumer (D-NY) shocked Washington, D.C. when they announced an agreement around a budget reconciliation package that includes clean energy and health care provisions and tax reform. The...more
Key Points:
The OASH under HHS is soliciting input from the public on its 2022 Environmental Justice Strategy and Implementation Plan Draft Outline. Comments are due to HHS by May 19, 2022.
The 2022 HHS Environmental...more
In October of 2018, Congress passed the SUPPORT for Patients and Communities Act (P.L. 115-271). The comprehensive opioid treatment law passed both chambers of Congress with large bipartisan support and tackled many aspects...more
With the second session of the 117th Congress underway, stakeholders are poised for another busy legislative session set against the dynamic backdrop of an ongoing global pandemic and midterm election year. Numerous...more
The Office of Climate Change and Health Equity -
The Department of Health and Human Services (HHS) recently established the Office of Climate Change and Health Equity (OCCHE), reinforcing the Biden-Harris administration’s...more
For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more
10/8/2021
/ Biden Administration ,
Biomedical Advanced Research and Development Authority (BARDA) ,
China ,
Competition ,
Coronavirus/COVID-19 ,
Defense Production Act ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
NDAA ,
Pharmaceutical Industry ,
Supply Chain
As has been widely reported, earlier this summer, President Biden issued Executive Order (EO) 14036, “Promoting Competition in the American Economy.” The EO provides insight into how the Biden-Harris administration plans to...more
9/10/2021
/ Biden Administration ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Competition ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Healthcare Reform ,
Hospitals ,
Life Sciences ,
Pharmaceutical Industry