News & Analysis as of

Generic Drugs Food and Drug Administration (FDA) Executive Orders

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Sheppard Mullin Richter & Hampton LLP

The March on Pharmaceutical Patents?

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more

Goodwin

FDA Commissioner Delivers Remarks at FDA-U.S. Patent and Trademark Office Public Workshop

Goodwin on

On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA...more

Foley & Lardner LLP

UPSTO Continues Discussion of Pharmaceutical Patents

Foley & Lardner LLP on

The USPTO will be hosting a “public listening session” on January 19, 2023, focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's Executive Order on “Promoting Competition in the American...more

Goodwin

Request for Comments on USPTO-FDA Collaboration Initiatives to Promote Generic Drug and Biosimilar Competition

Goodwin on

​​​​​​​On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

Haug Partners LLP

FDA Acting Commissioner of Food and Drugs Seeks Collaboration Between FDA and USPTO to Address Pharmaceutical Patent-Related...

Haug Partners LLP on

On September 10, 2021, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. Patent and Trademark Office (USPTO), which raised several of...more

Goodwin

President Biden Issues Executive Order Including Provisions To Promote Generic Drug and Biosimilar Competition in the American...

Goodwin on

On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions...more

MoFo Life Sciences

Biden Administration Executive Order On Promoting Competition In The American Economy: Drug Pricing And Healthcare Industry...

MoFo Life Sciences on

On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more

Skadden, Arps, Slate, Meagher & Flom LLP

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

McDermott Will & Emery

FDA 2017 Year in Review

McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

Dorsey & Whitney LLP

New York Times Obtains Copy of Draft Executive Order on Drug Prices; FDA Blogs that it is Working to Lift Barriers to Generic Drug...

Dorsey & Whitney LLP on

On June 20, 2017, the New York Times reported that it had obtained a draft proposal of President Trump’s Executive Order on drug prices. The draft Executive Order, which has not been published, has been characterized as...more

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