News & Analysis as of

Department of Justice (DOJ) Regulatory Reform Food and Drug Administration (FDA)

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

Troutman Pepper Locke on

On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

Hogan Lovells

White House Issues Executive Order Limiting Criminal Enforcement of Regulatory Offenses

Hogan Lovells on

On May 9, 2025, the White House issued an Executive Order, “Fighting Overcriminalization in Federal Regulations,” that seeks to place limits on the criminal enforcement of regulatory offenses, particularly those that impose...more

McDermott Will & Emery

Will It (Puff, Puff) Pass? Cannabis Reform Under the Trump Administration

McDermott Will & Emery on

The Trump administration’s approach to cannabis reform will significantly impact the industry. As the proposed rulemaking to reschedule cannabis unfolds and nominees to critical agencies are confirmed, it is crucial for...more

Arnall Golden Gregory LLP

Foreign Drug and Medical Device Manufacturers Under a Second Trump Administration: Increased Enforcement Scrutiny?

As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, less attention has been given to the new administration’s regulatory impact abroad....more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing and Health Care Fraud Remain Key Issues

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

Akin Gump Strauss Hauer & Feld LLP

High Stakes: HHS Shakes Things Up on Marijuana Scheduling and DEA Abides

On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more

Holland & Knight LLP

Holland & Knight Health Dose: May 14, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Neal, Gerber & Eisenberg LLP

Client Alert: HHS Recommends Rescheduling Marijuana to Schedule III: Implications and Uncertainties for the Industry

Marijuana has long been classified as a Schedule I controlled substance under the Controlled Substances Act of 1970 (the “CSA”), which is defined as a substance with no accepted medical use and a high potential for abuse,...more

McAfee & Taft

Unpacking possible change to marijuana classification

McAfee & Taft on

You may have heard that the federal government may downgrade marijuana from a “Schedule I” to “Schedule III” drug, but do you know the implications of such a change? In October 2022, President Biden issued an executive order...more

McAfee & Taft

Possible downgrading of marijuana to Schedule III drug carries with it significant implications

McAfee & Taft on

If the U.S. Department of Health and Human Services’ recent recommendation to reclassify marijuana as a Schedule III drug is adopted, expect far-reaching consequences. In October 2022, President Biden issued an executive...more

Stinson LLP

Missouri Financial Institutions Must Prepare for Impending Marijuana Banking Challenges

Stinson LLP on

In November 2018, Missouri voters passed Amendment 2, setting in motion state regulated medical marijuana. Over the last month, the Missouri Department of Health & Senior Services (DHSS) began approving license applications...more

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