Now that the dust has settled following the Supreme Court’s overhaul of administrative law through three late-term decisions, Akin litigators and policy advisors offer the most significant takeaways for businesses and...more
7/31/2024
/ CFTC ,
Chevron Deference ,
Chevron v NRDC ,
Consumer Financial Protection Bureau (CFPB) ,
Department of Justice (DOJ) ,
Department of Transportation (DOT) ,
Enforcement ,
FERC ,
Food and Drug Administration (FDA) ,
Loper Bright Enterprises v Raimondo ,
OSHA ,
Regulatory Agencies ,
SCOTUS ,
SEC v Jarkesy ,
Securities and Exchange Commission (SEC) ,
Settlement ,
Statutory Interpretation
On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more
Key Points -
The Supreme Court invalidated 2018 and 2019 cuts to Medicare reimbursement rates for hospital outpatient drugs acquired through the 340B Drug Pricing Program, effectively reinstating the default rate of ASP...more
- The Department of Justice (DOJ) will focus its civil enforcement activity on fraud and other illegal actions relating to COVID-19, including with respect to CARES Act stimulus programs and consumer products marketed for use...more
7/6/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Main Street Lending Programs ,
Paycheck Protection Program (PPP) ,
Private Equity Firms ,
Qui Tam
- Federal emergency authorities targeting COVID-19 provide important protections to businesses for certain actions in connection with the national response to the public health crisis.
- The protections include immunity...more
4/22/2020
/ Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Defense Production Act ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Immunity ,
Liability ,
Public Health ,
Public Health Emergency ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Sanctions ,
Stark Law ,
Volunteers ,
Waivers
While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more
4/1/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Stimulus ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medical Supplies ,
Medical Testing ,
Over The Counter Drugs (OTC) ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Relief Measures
- Federal agencies’ regulatory interpretations falling short of the standards laid out in Kisor are not surviving judicial review.
- Courts are closely scrutinizing regulations to determine if they are genuinely...more
On March 11, the World Health Organization (WHO) declared COVID-19 a global pandemic. The same day, the National Basketball Association, Major League Baseball, National Hockey League and Major League Soccer all suspended...more
On August 1, 2019, the U.S. District Court for the District of Columbia affirmed the U.S. Food and Drug Administration’s (FDA’s) decision to exclude the bulk drug substance vasopressin from the agency’s List of Bulk Drug...more
Food Marketing Institute v. Argus Leader Media, decided June 24, 2019 by the Supreme Court, substantially expands the Freedom of Information Act exemption for confidential business information. The ruling is significant for...more
7/2/2019
/ Appeals ,
Confidential Information ,
Congressional Intent ,
Exemptions ,
FOIA ,
Food Marketing Institute v Argus Leader Media ,
Motion to Compel ,
Private Commercial or Financial Information ,
Protected Disclosures ,
Reversal ,
SCOTUS ,
SNAP Program ,
Statutory Interpretation ,
Substantial-Competitive-Harm Test ,
Trade Secrets ,
USDA
On April 11, 2019, acting director of the Office of Management and Budget (OMB) Russell Vought announced a policy for review of federal agency rules and guidance that represents a significant change of process for issuance of...more
On January 25, 2018, the Associate Attorney General directed the Department of Justice (DOJ) not to rely on agency guidance documents to establish a violation in affirmative civil enforcement (“ACE”) cases. She issued the...more