News & Analysis as of

Free Speech & Pharmaceutical Promotion — U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc.

Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful...more

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling

On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Product labeling requirements aren't all black and white

Your company has created and developed a new, innovative product. You’ve tested your product, you’ve adopted a new trademark, and you’re ready to begin manufacturing. The remaining steps of preparing your product for sale,...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

Vermont Doubles Down: Representative Testifies Before Congress Against Federal GMO Labeling Bill

As we’ve explored in past posts, Congress is currently considering a bill that aims to harmonize the patchwork of state efforts at regulating GMO labeling by placing such regulation firmly within FDA’s jurisdiction. Dubbed...more

Health Care Update - December 2014

In This Issue: - FDA Releases Menu Labeling Rule - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Upcoming Congressional Hearings - Excerpt from FDA...more

Food and Beverage News and Trends

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Advocates of GMO labeling vow to continue fight even after electoral...more

Advertising Law - November 2014 #3

NAD Sniffs at Odor Protection Claims - Concerned that a 48 hour antiperspirant/deodorant constitutes an overstated claim of “100% odor protection,” the National Advertising Division recommended...more

California Court Has a Bone to Pick with Male Enhancement Pill Maker

We try to avoid puns in this blog but sometimes, well, we just can’t help it. The makers of “Rockhard Weekend,” a male sex enhancement pill, have successfully sidestepped a claim that they violated federal drug...more

The GPMemorandum, Issue 182

In This Issue: - Supreme Court Holds Company Can Sue Competitor For Unfair Competition Even If It Complies With FDA Labeling Regulations: In an 8-0 decision announced on June 12, 2014, the Supreme Court held...more

Grand Opening of openFDA.gov

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

FDA Launches Huge Online Database of Adverse Events

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

"All natural" litigation - California’s litigation boom could be spreading closer to home

The typical suit alleges that consumers are misled because a product labeled as “all natural” in fact contains one or more ingredients that are not natural. A plaintiff who purchased the product can file suit on behalf...more

Court Issues Sweet Ruling for Plaintiffs in Mislabeling Action – Ignorance That “Evaporated Cane Juice” Is An Added Sugar Not...

In Morgan v. Wallaby Yogurt Co., Inc., the U.S. District Court for the Northern District of California denied defendant’s motion to dismiss a class action complaint alleging violations of the UCL, FAL, and CLRA for...more

Living off the Label

Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label...more

Proposed FDA Labeling Revisions Would Impact Wines Below 7 Percent ABV and Certain Non-Malt Beers

On March 3, 2014, the Food & Drug Administration (FDA) published a Notice of Proposed Rulemaking (NPRM) that, if and when finalized, would make important changes to the labeling of all foods subject to FDA’s primary labeling...more

$4 billion price tag? FDA's proposed generic drug labelling rule

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow...more

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - The House will take another turn this week on hearings related to health care reform implementation with a focus on the Healthcare.gov website troubles. The House is also planning a vote on H.R....more

FDA Launches Medical Device ID Requirement

On September 24, 2013, the Food and Drug Administration (FDA) finalized a new rule requiring medical devices to bear special ID numbers. The numbers, called Unique Device Identifiers or UDIs, will identify the manufacturer,...more

Medical Device Postmarket Compliance in the United States

Introduction - Once the U.S. Food and Drug Administration (FDA or “the agency”) has cleared or approved a medical device for marketing in the United States, there are still significant postmarketing requirements with...more

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

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