U.S. Supreme Court overrules Chevron and restores courts’ obligation to exercise independent judgment -
On June 28, 2024, in one of the last decisions of the Term, the U.S. Supreme Court issued its long-awaited decision in...more
On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more
7/31/2020
/ Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Notice of Proposed Rulemaking (NOPR) ,
Prescription Drugs ,
Public Safety ,
State Implementation Plans (SIPs) ,
Trump Administration ,
Waivers
Lessons For The COVID-19 Pandemic Landscape -
INTRODUCTION -
Over the last two months, there has been a flurry of federal, state, and local government action to stem the spread of COVID-19. These efforts have included...more
On March 27, 2020, Congress passed the Coronavirus Aid, Relief and Economic Security (CARES) Act, which authorized $2.2 trillion to, among other things, help companies and individuals mitigate the financial repercussions...more
4/9/2020
/ Banks ,
Business Closures ,
Business Interruption ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Families First Coronavirus Response Act (FFCRA) ,
Federal Loans ,
Federal Reserve ,
Financial Stimulus ,
Health Care Providers ,
Healthcare ,
Lenders ,
Lending ,
Liquidity ,
Medicaid ,
Medicare ,
Nonprofits ,
Paycheck Protection Program (PPP) ,
Payroll Taxes ,
Relief Measures ,
SBA ,
SBA Lending Programs ,
Securities and Exchange Commission (SEC) ,
Small Business ,
Tax Relief ,
Unemployment Insurance
If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials -
Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more
3/4/2020
/ Article III ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Federal Rule 12(b)(1) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Motion for Summary Judgment ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Preamble ,
Public Health Service Act ,
Retroactive Application ,
Rules of Appellate Procedure ,
Standard of Review ,
Standing
On October 9, 2019, President Trump signed two executive orders: Promoting the Rule of Law Through Improved Agency Guidance (Executive Order 13891) (the “Guidance Executive Order”) and Promoting the Rule of Law Through...more
10/16/2019
/ Administrative Interpretation ,
Auer Deference ,
Department of Justice (DOJ) ,
Draft Guidance ,
Enforcement Authority ,
Exceptions ,
Executive Orders ,
Kisor v Wilkie ,
Regulatory Agencies ,
Regulatory Standards ,
Rulemaking Process ,
Trump Administration
Following the lead of the Department of Justice, several agencies issued statements disclaiming guidance as legally binding authority. The Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation,...more
On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum significantly restricting Department of Justice (“DOJ” or “the Department”) civil litigating units’ use of executive agency guidance documents...more
On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more
In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more
Program Has Broad Reach -
On October 21, 2016, the Food and Drug Administration launched a webpage that contains an Allegations of Regulatory Misconduct Form to enable whistleblowers, competitors, and others to report...more