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

Amicus Briefs on Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

Bipartisan Senate Bill Would Introduce Largest Increase in FDA Oversight of Personal Care Products—Including Cosmetics—in over 70...

Personal care products, which include cosmetics, are a large, profitable, growth industry. In the United States, cosmetics are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug & Cosmetic...more

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more

The FDA Gets an EARful on Label Changes

We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws. We have been remiss, however, in not mentioning the industry’s 2014...more

Food Recalls Increase in First Quarter of 2015

Food producers are reporting a sharp rise in food recalls so far this year. During the first quarter of 2015, the U.S. Food and Drug Administration (FDA) published notices of 118 food recalls (excluding pet foods), and the...more

Apotex Inc. v. Daiichi Sankyo, Inc.

Case Name: Apotex Inc. v. Daiichi Sankyo, Inc., 2014-1282, -1291 2015 U.S. App. LEXIS 5134 (Fed. Cir. Mar. 31, 2015) (Circuit Judges Taranto, Mayer, and Clevenger presiding; Opinion by Taranto, J.) (Appeal from N.D. Ill.,...more

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more

FDA, CMS Form Interagency Task Force on LDT Quality Requirements

FDA and CMS have announced that they are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs) -- tests intended for clinical use and designed,...more

First Circuit Decision Strengthens Preemption Defense in Name-Brand Pharmaceutical Litigation

On February 20, 2015, the U.S. Court of Appeals for the First Circuit affirmed the dismissal of plaintiffs’ state-law consumer protection claims against a name-brand pharmaceutical manufacturer, concluding they were impliedly...more

You Should Know - April 2015

In This Issue: - Devices Go Awry - Protect Against Risks - Insiders Talk - Excerpt from Faulty Products Put Patients at Risk: Some Popular Medical Devices Escape FDA Scrutiny: Countless patients around the...more

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

As discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015...more

Section 337’s Potential for Defending Biologics Market Share Against Biosimilars

Enforcement of biologic patents at the United States International Trade Commission under Section 337 provides certainty and tactical advantages to patent holders that are unavailable in district court under the BPCIA. For...more

FDA Issues First E-Cigarette Warning Letters

While FDA’s tobacco products “deeming rule” is pending, the Agency issues Warning Letters to e-cigarette and e-liquid companies for the first time....more

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more

Otsuka’s Pediatric Labeling Dispute Seeks to Expand Orphan Drug Exclusivity

On April 13, 2015, the U.S. District Court for the District of Maryland issued an Order granting Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America...more

Amgen Receives No Help from the FDA -- A Biosimilar Update

Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and...more

Washington Healthcare Update

This Week: Montana Legislature Reverses Course, Endorses Medicaid Expansion... Final 2016 Medicare Advantage and Part D Rate Announcement and Call Letter... Upcoming: Energy and Commerce Subcommittee Hearing on Post-Acute...more

Also In The News - Health Headlines - April 2015

Guidance Issued on Payment for Biosimilars – On March 30, 2015, CMS released three guidance documents detailing the policies that will govern FDA-approved biosimilars under the Medicare Part B and Part D benefits, and how...more

Ninth Circuit Upholds FDA’s Primary Jurisdiction Over “Natural” Labeling On Cosmetics But Orders Stay Rather Than Dismissal

Plaintiffs’ lawyers love to challenge products labeled as “natural,” with hundreds of false advertising class actions filed in just the last few years. Recently, in Astiana v. Hain Celestial (pdf), the Ninth Circuit reversed...more

Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements [Video]

The FDA provides oversight of dietary supplements. Recently, the New York Attorney General's Office sent cease and desist letters to four major national retailers accusing them of selling dietary supplements that failed to...more

Healthcare Legal News Volume 5 Number 2

According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

Court Declines to Certify Class Alleging Off-Label Marketing of Cancer Drug

Third party payors (“TPPs”) responsible for paying the costs of prescriptions for their beneficiaries sued Cephalon, Inc., alleging that it engaged in unlawful off-label marketing of Actiq, a drug approved to manage...more

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...more

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA [Video]

The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

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