News & Analysis as of

Biologics Trump Administration

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 2

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In Washington: In a statement on Monday, Food and Drug Administration (FDA) Commissioner Stephen Hahn and Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, responded that it was...more

McDermott Will & Emery

An Early Holiday Present for Generics? Legislation Requiring Greater Disclosure by Brands Passes the Senate

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Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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In Tuesday's Report: FDA lists essential medicines and medical countermeasures, Trump plans health official replacement, FDA expands remote monitoring exemption list, WHO director self-quarantines, and other U.S. White House...more

Hogan Lovells

FDA issues list of essential medicines and countermeasures required under Buy American Executive Order

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Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration (FDA) announced that it published a list of 223 drug and...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

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On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Kramer Levin Naftalis & Frankel LLP

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

BakerHostetler

Capitol Hill Healthcare Update

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NEW SENATOR JOINS HEALTH COMMITTEE - Newly sworn-in Sen. Kelly Loeffler, R-Ga., is the newest member of the Senate Health, Education, Labor and Pensions Committee....more

Smart & Biggar

What the amendments to the USMCA mean for Canadian IP law

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On December 10, 2019, Canada, the United States and Mexico signed the Protocol of Amendment to the Agreement between the United States of America, the United Mexican States and Canada (commonly referred to as the USMCA). The...more

Goodwin

10-Year Data Exclusivity for Biologics Removed from Final USMCA Agreement

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On December 10, 2019, the House Democrats and Trump administration reached an agreement on the United States-Mexico-Canada Agreement (USMCA), which would replace the North American Free Trade Agreement (NAFTA) of 1994....more

McDonnell Boehnen Hulbert & Berghoff LLP

Trump Administration Considering Reduction in Biologics Exclusivity Period

On Monday, December 2, 2019, The Wall Street Journal reported that the Trump administration is considering reducing the 12-year data exclusivity period for biologic drugs set forth in the Biologics Price Competition and...more

Wilson Sonsini Goodrich & Rosati

FDA Updates Paragraph IV Certification List to Help Spur Investment in Generic Drug Development

Recently, the U.S. Food and Drug Administration, or the FDA, announced enhancement of the FDA's Paragraph IV Patent Certification List (the List) as part of the agency's stated goal of bringing more generic drugs to market...more

WilmerHale

U.S., Mexico, Canada Agree to Update NAFTA

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After more than a year of sometimes contentious negotiations, the United States, Mexico, and Canada (the “Parties”) reached an agreement late Sunday night to revise the North American Free Trade Agreement (“NAFTA”)—renaming...more

Goodwin

USMCA Trade Agreement Includes Minimum 10-Year Data Exclusivity for Biologics

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On October 1, the Trump administration announced that it had secured a new trade agreement with Canada and Mexico. The United States-Mexico-Canada Agreement (USMCA) would replace the North American Free Trade Agreement...more

Sheppard Mullin Richter & Hampton LLP

NAFTA Agreement Reached at the Eleventh Hour

A tripartite agreement to save NAFTA has been reached. The agreement, reached late last night, provides Congress the necessary 60 days’ notice of the text to approve so that President Pena Nieto of Mexico can sign before he...more

Ladas & Parry LLP

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

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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

Baker Donelson

CMS Proposes More Payment Changes for 340B Hospitals in 2019

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The Medicare program is once again looking to reduce payments to 340B hospitals for Part B drugs and biologicals. As part of its proposed payment regulation for hospitals under the Outpatient Prospective Payment System (OPPS)...more

BakerHostetler

Capitol Hill Healthcare Update

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LAWMAKERS COOL TO TRUMP PLAN ON HHS, GOVERNMENT REORGANIZATION - The response from lawmakers on Capitol Hill to the White House plan to reorganize the federal government – including proposed changes to multiple healthcare...more

McDonnell Boehnen Hulbert & Berghoff LLP

Comprehensive and Progressive Agreement for Trans-Pacific Partnership May Differ Significantly from TPP

In the wake of President Trump's decision to withdraw from the Trans-Pacific Partnership, the other countries involved in negotiations (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore,...more

Akin Gump Strauss Hauer & Feld LLP

Congress Makes Key Changes to Medicare Physician Payment Programs as Part of Short-Term Government Funding Bill

• Congress amended current law to prevent CMS from applying the “MIPS” payment adjustment to separately billed items like drugs and biologics, which will drastically reduce the total amount of payment adjustments to clinical...more

Mintz - Health Care Viewpoints

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more

Patterson Belknap Webb & Tyler LLP

100 Days Plus Under Trump: What They Mean for Biologics

President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

Patterson Belknap Webb & Tyler LLP

Republican Healthcare Bill Would Leave BPCIA Untouched

In public debates over the Affordable Care Act (ACA), also known as Obamacare, biosimilars are rarely, if ever, mentioned. But the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA), was in...more

Goodwin

Trump Withdraws From the TPP

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As previously posted, President Trump has stated that he planned to issue a notification of intent to withdraw from the Trans-Pacific Partnership (TPP), which is a proposed trade agreement between several pacific countries...more

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