The Presumption of Innocence Podcast: Episode 66 - Tariff Uncertainty and Compliance Risks for Businesses
Hot Topics in International Trade - Let's Be Serious-Supply Chain Audits
Episode 372 -- DOJ Applies False Claims Act to Tariff and Trade Violations
CHPS Podcast Episode 4: Tariffs and Trade Impact
Episode 369 -- Stepping Into the Enforcement Spotlight -- Customs and Border Patrol and Import Enforcement
Wiley's 2025 Key Trade Developments Series: Trade Remedies
Wiley's 2025 Key Trade Developments Series: U.S.-Mexico-Canada Agreement (USMCA)
Compliance Tip of the Day: The Role of Supply Chain and Compliance in Tariffs
CHPS Podcast Episode 3: Unlocking America's Mineral Potential
Tariffs and Trade Series: Effects on Agriculture Operations and Markets
Episode 358 - Ethics and Compliance Trends for 2025: Is Your Company Prepared?
U.S. Introduces “Fair and Reciprocal Plan,” Marking Significant and Impactful Shift in Trade Policy
A Brief Primer on Tariffs Under the Trump Administration
Hot Topics in International Trade 2024 Presidential Election and Trade with BLG Senior Associate Attorney Kerry Wang
Hot Topics in International Trade FTZ's and the Business Drift
Hot Topics in International Trade USMCA facilitation
Hot Topics in International Trade - Managed Services and FTZs
US-China International Trade Law: What You Need to Know Now
4 Key Takeaways | Solar Industry & Chinese Tariff Update
Hot Topics in International Trade-De Minimis With Bob Brewer, and Robert Stein, VP Braumiller Consulting
President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
While much of Washington, DC’s attention this week has been focused on congressional action around budget reconciliation, including proposed changes to the Medicaid program, the White House also made news with release of a...more
On Monday, May 12, President Donald Trump signed an Executive Order (EO) titled, “Delivering Most-Favored-Nation Prescription Drug Pricing to Americans,” aimed at reducing prescription drug prices by implementing a...more
President Donald Trump on May 12, 2025, issued an executive order (EO) titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients" and an accompanying Fact Sheet, "President Donald J. Trump...more
On April 15, 2025, President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order reaffirms and seeks to expand on policy initiatives introduced during the president’s...more
The head of the U.S. Department of Justice (DOJ) branch that oversees False Claims Act (FCA) investigations affirmed the Trump Administration’s commitment to pursue civil fraud cases as part of its focus on achieving...more
Following a hotly contested election, Donald Trump is once again the president-elect and will return to the White House on January 20, 2025. He will do so with a dominant electoral college win, potentially a win of the...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more
On Friday, January 5, 2024, the US Food and Drug Administration (FDA) authorized the Section 804 Importation Program (SIP) proposal of Florida’s Agency for Health Care Administration (FAHCA). The SIP is a pathway that allows...more
In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more
Inflation Reduction Act: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022. Republican leaders on the House Energy & Commerce and...more
There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...more
The Center for Biological Diversity and the Natural Resources Defense Council submitted a petition for rule-making to the Secretary of the U.S. Department of Health and Human Services and the Centers for Disease Control and...more
As we previously reported, in July 2019 the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (Action Plan) created with the FDA to allow the importation of certain prescription drugs...more
As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more
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
President Trump signed four executive orders on July 24, 2020, that appear to push forward the administration’s efforts to lower prescription drug costs and pass the savings on to consumers. ...more
FDA Enters New Phase Of FSVP Enforcement - The U.S. Food and Drug Administration (FDA) has entered a new phase of enforcement for the Foreign Supplier Verification Program (FSVP) regulation, the legally required due...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more
While a number of state initiatives have sought to control prescription drug costs — such as through regulation of pharmacy benefit manager practices, anti-price gouging, price transparency, and rate-setting review — the use...more
On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan, to allow certain entities to import...more
Since its enactment in 2003, Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) has been a dead letter in the law. The provision authorizes the importation of certain prescription drugs from Canada, but only if...more