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Freedom of Information Act › Pharmaceutical Industry

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... more +
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 -
Proskauer Rose LLP

FTC Focus: What Access To Patent Settlements Would Mean

Proskauer Rose LLP on

The Federal Trade Commission has pursued aggressive and creative expansion of its antitrust enforcement efforts under the Biden administration, and the pharmaceutical industry is no exception. Indeed, in a recent interview,...more

Epstein Becker & Green

Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not...

Epstein Becker & Green on

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

Epstein Becker & Green

Unpacking Averages: FDA FOIA Response Times by Topic of Request

Epstein Becker & Green on

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

Epstein Becker & Green

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

Epstein Becker & Green on

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

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

Arnall Golden Gregory LLP

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

Arnall Golden Gregory LLP on

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

Haug Partners LLP

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

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

Wilson Sonsini Goodrich & Rosati

FDA Launches Website for Allegations Against Medical Device Manufacturers

Wilson Sonsini Goodrich & Rosati on

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

Troutman Pepper

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

Troutman Pepper on

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

Troutman Pepper

Bass Continues Fishing; Pharma Seeks Sanctuary

Troutman Pepper on

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

Troutman Pepper

A Radical Overhaul? The Third Circuit Analyzes the Federal False Claims Act's Public Disclosure Bar after the Patient Protection...

Troutman Pepper on

To dismiss a case based on the public disclosure bar, the defense will have to establish that the allegations of fraud already were exposed in the news media or certain federal sources of information. Pharmaceutical,...more

Morrison & Foerster LLP

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

Morrison & Foerster LLP on

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

Patrick Malone & Associates P.C. | DC Injury...

Grand Opening of openFDA.gov

Patrick Malone & Associates P.C. | DC Injury... on

Information is power, and as of this month, there’s a new power source of information about drug effects. openFDA.gov is an initiative of the U.S. Food and Drug Administration to expand access to and use of reports of...more

Faegre Drinker Biddle & Reath LLP

FDA Launches Huge Online Database of Adverse Events

Faegre Drinker Biddle & Reath LLP on

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more

Orrick - Trade Secrets Group

Trade Secrets Trend To Watch In 2014: Government Regulations Requiring Public Disclosure Of Proprietary Information

Orrick - Trade Secrets Group on

In the New Year, one of the trade secret trends we’re watching is the ongoing tension between a company’s interest in preserving its proprietary information and the public’s demand to know more about the goods or services it...more

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