News & Analysis as of

Imports Canada Pharmaceutical Industry

Husch Blackwell LLP

Week Twenty-Four in Trade

Husch Blackwell LLP on

President Trump Announces Higher Tariff Rates Effective August 1st- After announcing an extension of the reciprocal tariff rates from July 9, 2025, to August 1,2025, President Trump published letters which were sent to...more

Braumiller Law Group, PLLC

Hot Topics in International Trade - June 2025 - Trump’s Plan B for Tariffs

On May 28, 2025, the United States’ Court of International Trade (CIT) struck down the President’s use of the International Economic Emergency Powers Act (IEEPA) to impose tariffs. This includes tariffs imposed on Canada,...more

ArentFox Schiff

232 Investigation of Pharmaceuticals: Potential Tariffs and Tight Comment Deadline

ArentFox Schiff on

Effective April 5, the United States imposed a 10% baseline tariff on imports from nearly all countries, excluding products from Canada and Mexico, and those products contained in the Harmonized Tariff Schedule of the United...more

A&O Shearman

U.S. tariffs in the pharmaceutical sector

A&O Shearman on

Since taking office in January 2025, the Trump Administration has announced, imposed, or reimposed various tariff-related restrictions on articles imported into the United States. These proposed tariffs and their...more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

Jones Day on

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

Arnall Golden Gregory LLP

What Lies Ahead, We Have No Way of Knowing: FDA Authorizes Florida’s Drug Importation Program

A recent development with the Food and Drug Administration made us think of a song lyric from Florida native and Rock and Roll Hall of Famer, Tom Petty, “What lies ahead, [we] have no way of knowing.” As a kick-off to 2024,...more

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

Quarles & Brady LLP on

On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

Cooley LLP

FDA Greenlights Florida’s Proposal for Importing Prescription Drugs From Canada

Cooley LLP on

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

Foley & Lardner LLP

FDA: Major Policy Shift Authorizes Florida’s Plan to Import Drugs from Canada

Foley & Lardner LLP on

On Friday, January 5, 2024, in a major policy shift, the U.S. Food & Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s plan to purchase medicines in bulk for its Medicaid programs,...more

Hogan Lovells

Florida still has a long way to go before it can begin importing certain Canadian drugs

Hogan Lovells on

On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s proposal under the Section 804 Importation Program (SIP) to allow Florida to proceed to the next steps in the regulatory process to import...more

BakerHostetler

FDA Authorizes Florida’s Drug Importation Program

BakerHostetler on

On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval. Generally, there are three pathways to importing a prescription drug into the United...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - September 2022

Latham & Watkins LLP on

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

Smart & Biggar

Health Canada – COVID-19 update highlights

Smart & Biggar on

UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Goodwin

Canada, PhRMA and Others Challenge U.S. Prescription Drug Rules

Goodwin on

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

Smart & Biggar

U.S. rule permitting import of drugs from Canada prompts Health Canada to release Interim Order prohibiting exports that may risk...

Smart & Biggar on

UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Arnall Golden Gregory LLP

A Guide to FDA’s Final Rule on the Importation of Prescription Drugs from Canada

On September 25, 2020, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)....more

Smart & Biggar

Health Canada facilitates availability of COVID-19 health products

Smart & Biggar on

UPDATE: The Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 was made on March 1, 2021 (see Notice here) and repeals the Interim Order Respecting the Importation and...more

Herbert Smith Freehills Kramer

USMCA: Implications for Biologics and Innovation

On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more

Robins Kaplan LLP

Financial Daily Dose 1.17.2020 | Top Story: Senate Passes USMCA by Wide Margin to Update NAFTA

Robins Kaplan LLP on

While there’s plenty of other business afoot in D.C. these days, it also happens to have been a pretty big week for trade deals. A day after Phase One with China was inked, the Senate overwhelmingly approved a revised...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

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

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Issues Proposed Policies to Facilitate Importation of Prescription Drugs from Canada, Other Countries

• 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

Akerman LLP - Health Law Rx

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies.  President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more

Blank Rome LLP

Will HHS’s Safe Importation Action Plan Affect How the Federal Government Purchases Drugs?

Blank Rome LLP on

On July 31, the Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) announced their latest plan to reduce the prices Americans pay for prescription drugs. The Safe Importation Action...more

Hogan Lovells

AFTA NAFTA: USMCA and the path forward

Hogan Lovells on

On 30 September, after an intensive, last-minute flurry of negotiations, Canada joined the United States and Mexico in a new trilateral agreement to replace the original North American Free Trade Agreement (NAFTA 1.0). ...more

Ladas & Parry LLP

USMCA – New Agreement as to The Modernization of NAFTA Comes with Key Changes Regarding U.S. IP Rights

Ladas & Parry LLP on

Late on September 30, an agreement (USMCA) was reached between the United States, Mexico and Canada which modernizes the 24 year old North American Free Trade Agreement (NAFTA)....more

25 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide