News & Analysis as of September 13, 2024

Freedom of Information Act › Food and Drug Administration (FDA)

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The Freedom of Information Act is a United States federal statute enacted in 1966 to promote government transparency and the free exchange of public information. Under FOIA, any individual can request federal agency records and enforce that right in a court of law. However, not all agency records can be requested; there are nine exempt categories of information. In addition to the federal law, many states have passed their own freedom of information acts. These acts are often similar but not always identical to the federal version. less -

HHS Marijuana Recommendation Now on Blast

Husch Blackwell LLP on 1/16/2024

In October 2022, President Biden asked the Department of Health and Human Services (HHS) and the Attorney General to review how marijuana is scheduled under federal law. In August 2023, the HHS marijuana recommendation went...more

FDA Draft Guidance Provides Further Details on New Cosmetic Product Facility Registration and Product Listing Requirements

ArentFox Schiff on 8/10/2023

Earlier this week, the US Food and Drug Administration (FDA) issued draft Q&A guidance entitled “Registration and Listing of Cosmetic Product Facilities and Products,” which clarifies the agency’s expectations regarding the...more

FDA Publishes Draft Guidance on Cosmetic Product Facility Registration and Cosmetic Product Listing

Mintz - Health Care Viewpoints on 8/10/2023

On August 7, 2023, the Food and Drug Administration (FDA) published Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (the Draft Guidance), which provides much-needed...more

Juul Labs, Inc. v. FDA: A FOIA Twist on the Challenge to FDA's Marketing Denial Order

Troutman Pepper on 5/25/2023

Recent Freedom of Information Act (FOIA) litigation raises an interesting question: When federal agency action requires analyses under a holistic, multi-factor statutory standard, may the agency withhold from disclosure as...more

Concerns Over PFAS Contribute to New Federal Legislation Expanding FDA’s Authority Over Cosmetics

Pillsbury Winthrop Shaw Pittman LLP on 5/8/2023

Partly driven by recent litigation involving the presence of PFAS in cosmetics, the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 mandates more stringent FDA regulation of companies that manufacture cosmetics and...more

Unpacking Averages: Success Rates for FDA FOIAs by Topic and Requester

Epstein Becker & Green on 5/3/2023

In prior posts here and here, I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. I looked at response times and then started to dive into the topics that requesters were asking...more

Unpacking Averages: FDA FOIA Response Times by Topic of Request

Epstein Becker & Green on 4/4/2023

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive...more

Hidden FDA Report Raises Questions About Its Approach to Public Records and Premarket Tobacco Review

Troutman Pepper on 3/15/2023

FDA’s approach to a premarket tobacco product application (PMTA) raises new questions about whether its marketing denial order was arbitrary and capricious and whether the deliberative-process exemption justifies its...more

Initiatives to Increase Communication Between the USPTO and the FDA Concerning Pharmaceutical Patent Applications

Dechert LLP on 3/7/2023

President Biden, in July 2021, issued an Executive Order (“E.O.”) observing that “too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and...more

Unpacking Averages: Exploring New Data on FDA Responses to FOIA Requests

Epstein Becker & Green on 3/1/2023

Federal agencies in health care publish large amounts of data, and my posts typically analyze that data. To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional...more

Investigations Newsletter: DOJ Indicts 47 Individuals in Largest COVID-19 Fraud Scheme To Date

ArentFox Schiff on 9/23/2022

DOJ Indicts 47 Individuals in Largest COVID-19 Fraud Scheme To Date - On September 20, 2022, the US Department of Justice (“DOJ”) announced federal criminal charges against 47 defendants from the nonprofit, Feeding Our...more

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

Latham & Watkins LLP on 9/13/2022

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

Will the Next Therapeutic Emergency Use Authorization be for a Vaccine? FDA Announces Additional Steps to Increase Emergency Use...

Arnall Golden Gregory LLP on 11/19/2020

As Coronavirus cases continue to spike all over the country, two vaccine companies have announced promising early results for their respective products. On November 9, 2020, Pfizer Inc. and BioNTech SE announced that their...more

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

Haug Partners LLP on 9/18/2020

On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

Food & Beverage Litigation Update l November 2019 #2

Shook, Hardy & Bacon L.L.P. on 11/18/2019

LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more

Food & Beverage Litigation Update l March 2019

Shook, Hardy & Bacon L.L.P. on 3/8/2019

CBD, FSMA, Class Actions Among Topics at GMA Conference - Class action litigation, the legal landscape for cannabis and the evolving implementation of the Food Safety Modernization Act (FSMA) were trending topics at the...more

Updated: The Practical Impact of the Government Shutdown for Private Parties

Akin Gump Strauss Hauer & Feld LLP on 1/8/2019

The new 116th Congress convened on Thursday, January 3, 2019 as the partial government shutdown, carrying over from the prior Congress, continued into the new year and has now outlasted previous shutdowns. Although the...more

FDA Proposes New Rule to Increase Transparency and Access to Agency Documents Under FOIA

Hogan Lovells on 9/18/2018

The Food and Drug Administration (“FDA” or “the agency”) recently issued a proposed rule that will ease the Freedom of Information Act (“FOIA”) request process for certain records within FDA’s possession. The proposed rule...more

FDA Takes First Steps to Cut Regulations, Solicits Public Feedback

Mintz - Health Care Viewpoints on 9/12/2017

Since our March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred...more

Food & Beverage Litigation Update | June 2017 #3

Shook, Hardy & Bacon L.L.P. on 6/19/2017

FDA Delays Compliance Date for Nutrition Facts Labeling - The U.S. Food and Drug Administration (FDA) has announced that it will postpone the deadline for food companies to use a revised Nutrition Facts label on packaged...more

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

Patterson Belknap Webb & Tyler LLP on 11/3/2016

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

FDA Launches Website for Allegations Against Medical Device Manufacturers

Wilson Sonsini Goodrich & Rosati on 11/1/2016

The U.S. Food and Drug Administration (FDA) recently launched a website1 that will now make it easier to report allegations of medical device manufacturer misconduct to the agency.2 Misconduct reports were historically...more

Accepting Anonymous Tips: FDA's Website for Reporting Medical Device Regulatory Misconduct

Troutman Pepper on 10/31/2016

For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead. Unidentified tipsters — from disgruntled former employees to plaintiffs’ attorneys —...more

Bass Continues Fishing; Pharma Seeks Sanctuary

Troutman Pepper on 4/1/2016

It’s time for an update on Kyle Bass’s efforts to rid America of the pharmaceutical patents that support high priced drugs. Between February and September 2015, at least eleven investment funds organized by J. Kyle Bass and...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

Morrison & Foerster LLP on 6/18/2014

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

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Freedom of Information Act › Food and Drug Administration (FDA)

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