Food dye reform has been an area of focus for the Trump administration as part of its Make America Healthy Again (MAHA) initiative, giving momentum to an effort the Food and Drug Administration (FDA) had already started by...more
In March 2020, Congress enacted the first Over-the-Counter (OTC) Monograph Drug User Fee program (OMUFA) as part of the CARES Act (P.L. 116 – 136) to modernize the Food and Drug Administration’s regulation of OTC monograph...more
White House Releases America’s AI Action Plan On July 23, 2025, the White House released America’s AI Action Plan. The plan, initiated by President Donald J. Trump's Executive Order 14179, "Removing Barriers to American...more
This week, the U.S. Food and Drug Administration (FDA) granted another color additive petition, approving the use of Gardenia (Genipin) in various food and beverage products. This marks the fourth naturally-derived color...more
On May 19, 2025, President Trump signed the bipartisan TAKE IT DOWN Act into law. The Act criminalizes the publication of nonconsensual intimate visual depictions of individuals, including AI-generated deepfakes. Threats to...more
On May 5, President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines,” with the stated purpose of eliminating “regulatory barriers to the domestic production...more
On February 13, the Senate approved Robert F. Kennedy Jr.’s nomination to serve as Secretary of Health and Human Services and the White House shortly thereafter issued an Executive Order establishing the Make America Healthy...more
Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more
2/13/2025
/ Artificial Intelligence ,
Chevron Deference ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
Investment ,
Investors ,
Legislative Agendas ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Machine Learning ,
Medical Devices ,
Medicare Advantage ,
Popular ,
Prescription Drugs ,
Private Equity ,
Regulatory Agenda ,
Regulatory Reform ,
SCOTUS ,
Technology Sector ,
Trump Administration
In recent days, President-elect Trump has made progress in announcing the names of various individuals he intends to nominate to serve in some of the most senior and influential leadership positions at the Department of...more
Welcome to the January edition of Akin Intelligence. Artificial Intelligence (AI) remains a key area for state and federal legislators in the new year. State executives and legislators continue to propose AI-related...more
1/29/2024
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Biden Administration ,
Cyber Attacks ,
Employment Discrimination ,
Executive Orders ,
FCC ,
Federal Trade Commission (FTC) ,
Machine Learning ,
OMB ,
Request For Information ,
Software Developers ,
Trump Administration
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
8/13/2020
/ Best Practices ,
Coronavirus/COVID-19 ,
Counterfeiting ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
E-Commerce ,
Executive Orders ,
Exemptions ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Manufacturers ,
Medical Supplies ,
OMB ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Public Health ,
Reporting Requirements ,
Section 301 ,
Supply Chain ,
Trump Administration ,
Waivers ,
WTO
• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada.
• In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more
12/20/2019
/ Canada ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Imports ,
Manufacturers ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Proposed Rules ,
Supply Chain ,
Trade Policy ,
Trump Administration
• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted.
• Many of the more dramatic proposals would require federal rulemaking or...more
5/17/2018
/ Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Request For Information ,
Section 340B ,
Trade Agreements ,
Trump Administration ,
WTO