Tag Archives: Drug labeling

Is Your SEM FDA Compliant? New Google SEM Policy Forces Pharmaceutical Industry to Adjust Paid Search Advertisements

Upcoming changes to Google AdWords’ ad formats will have a significant impact on pharmaceutical companies that engage in paid search advertising. In a letter to its major media agencies last month, Google announced that it will be removing two of its popular pharmaceutical advertising units. Black Box Ad Format On July 20, 2015, Google’s Black … Continue Reading

A 50-State Survey of the Heeding Presumption

Over on the Drug & Device Law Blog, the bloggers have put together a survey of how each U.S. state (plus Washington, D.C. and Puerto Rico) has addressed the concept of the heeding presumption, which posits that if the manufacturer of a product had given an alternative "adequate" warning of the potential effects of using the product, then the consumer or learned intermediary of such product would have obeyed the warning. As the survey demonstrates, the states' reaction to this legal theory ranges from full recognition to limited recognition to full rejection.… Continue Reading

Do You Know Where Your Pharmaceuticals Are From? Navigating the “Country of Origin” Question for Pharmaceutical Products

Drug and medical device manufacturers are often faced with difficult challenges in determining the country of origin for their products, which are often sourced, processed and manufactured in multiple countries. As detailed by the article "Origin of the Pieces: How to Determine a Pharmaceutical Product's 'Country of Origin,'" written by Reed Smith lawyers Jeffrey Orenstein and Lorraine Campos, there are a variety of factors that must be taken into consideration when answering the country of origin question for a pharmaceutical product - chief among which is who is asking the question. This article provides an overview of the principal regulatory schemes and their country of origin standards in order to help provide clarity to pharmaceutical companies in an often confusing and frustrating process.… Continue Reading

FDA Announces Plan to Encourage Voluntary Updating of Drug and Biologics Labels

As mentioned on our Health Industry Washington Watch blog, the U.S. Food and Drug Administration (FDA) has announced a plan intended to incentivize manufacturers to voluntarily update their prescription drug and biologics labels. The plan calls for the use of a government contractor to assist manufacturers in making these updates according to the labeling guidelines … Continue Reading

Supreme Court Holds State Law Failure to Warn Claims Against Generics Preempted

This post was written by Christopher C. Foster. As many of you no doubt have heard, the United States Supreme Court last week decided that FDA regulations applicable to generic drug manufacturers preempt state law “failure to warn” claims in PLIVA, Inc. v. Mensing, Nos. 09–993, 09–1039, and 09–1501, 564 U.S. ___ (2011). Among other … Continue Reading

Latest Post-Levine Case Holds That Conflict Preemption Bars Plaintiff’s Failure-To-Warn Claims

One of the strongest defenses against product liability claims, including a failure to warn claim, is federal preemption. For cases against prescription drug manufacturers, defense lawyers have specifically asserted conflict preemption to argue that failure to warn claims are preempted by the FDA’s regulations governing the content of labels for prescription drugs. Essentially, defense lawyers … Continue Reading
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