The United States Food and Drug Administration

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

The FDA Tiptoes – and Congress Splashes Into – the 21st Century

Here are a couple of non-litigation related matters that we thought our readers need to know about. First, the FDA. We’ve pointed out before that the FDA’s “intended use” regulations for drugs (21 C.F.R. §201.128) and...more

United States v. Bayer: Preventing or Treating Disease Claims

In recent years, the FTC and the Center for Science in the Public Interest (“CSPI”) seem to have seen disease claims everywhere, regardless of whether the FDA has deemed the same claims appropriate, non-disease...more

Making Sense of the Daubert and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist....more

FDA Detects That a Screening Tool for Early Detection of Cancer Types Might Require More Sleuthing

The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. FDA...more

A&B Healthcare Week In Review, September 2015

On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System”. This proposed rule would...more

M.D. Fla. Shuts Down Attempted End-Run Around Learned Intermediary in Enbrel Case

Today’s case gives us a lesson and a laugh. The lesson is that a court can be persuaded to prevent enterprising plaintiff lawyers from turning warning adequacy and the learned intermediary rule into not-so-funny jokes. The...more

Inferior Vena Cava (IVC) Filter Failures and Bard's Cover Up: Part 2

We already know that IVC Filters are dangerous. We also already know that the manufacturers knew of the dangers but did nothing to protect the public. But did medical giant CR Bard, in order to obtain approval for their...more

Ruling Allows Gerber False Advertising Suit to Crawl Onward

For plaintiffs concerned that the Fourth Circuit Court of Appeals’ June 19, 2015 decision in Brown v. GNC Corp. signaled the muscling in of a stricter new pleading standard for false advertising class actions nationwide, a...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

Africa Update - September 2015 #4

Leading the News - Burkina Faso: On September 17th, U.S. National Security Advisor Susan Rice condemned the unconstitutional seizure of power by elements of the Presidential Security Regiment in Burkina Faso and...more

FDA Establishes Patient Engagement Advisory Committee

The FDA recently announced establishment of the Patient Engagement Advisory Committee (PEAC). According to a notice published by the FDA, the PEAC will advise the Commissioner of the FDA, presently Dr. Stephen Ostroff, M.D.,...more

Dirty Instruments Pose Threat to Outpatients, Too

Earlier this year, both patients and providers were shocked when a rash of hospital patients got seriously ill or died after medical devices used to examine their gastrointestinal tracts infected them because they were not...more

Many questions for, but not many answers from, the FDA on biosimilars implementation after last week's hearing

The US Senate Committee on Health, Education, Labor and Pensions on September 17, 2015 convened a hearing entitled Biosimilars Implementation: A Progress Report from the FDA. Dr. Janet Woodcock, Director of the Center for...more

Amgen Sues Hospira in Fourth Lawsuit Under the BPCIA

On September 18, 2015, Amgen sued Hospira in a fourth lawsuit under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The lawsuit concerns Hospira’s proposed biosimilar of Amgen’s Epogen (epoetin alfa)....more

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

[Event] 2015 Business of Personalized Medicine Summit - Oct. 7, San Francisco, CA

Just as with patient treatments, one size does not fit all when it comes to companies involved in personalized medicine. Each is unique in its mission, culture, and capabilities, and so it should come as no surprise that each...more

Fireworks for Animal Drug Compounding at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part Two...

The second day began with a deep dive into the development of advanced biological drugs for animal use. David Brake, Ph.D., Founder and Principal, BioQuest Associates, LLC, helped explain the split between USDA and FDA...more

Fireworks for Animal Compounding and More at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part...

On September 10-11, the American Conference Institute (ACI) held its inaugural Animal Health and Veterinary Drugs and Therapeutics Conference in New York City. The Conference featured two workshops: a pre-conference overview...more

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part One of Two

On September 16-18, 2015 the International Generic Pharmaceutical Alliance (IGPA) held its 18th Annual Meeting in Toronto, Canada. IGPA is composed of members: the Canadian Generic Pharmaceutical Association (CGPA-Canada),...more

In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices

We have alluded on a couple of occasions to the likelihood that the recent generic drug implied impossibility preemption decisions in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S....more

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

The FDA Takes the Kardashian Endorsement Machine to Task

When Kim Kardashian speaks, the FDA listens. Or, more precisely, when Kardashian, who has 46.8 million followers on Instagram, posts an enthusiastic endorsement—and advertisement—on the social media platform for Diclegis, a...more

Long-awaited overhaul of FDA food safety rules arrives – Part I: Introducing HARPC, changes to cGMP

Since the passage of the Food Safety Modernization Act in 2011, the FDA has promulgated proposed rules that overhaul the old Good Manufacturing Practice (cGMP) rule and create new Hazard Analysis and Risk-Based Preventative...more

Transfer Motion Is Denied

Instead of applying admittedly neutral Jumara factor arguments, Defendants urge the court to transfer instead based on the singular fact that the Maryland court had rendered a decision on a related patent and, thus, any forum...more

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