By Delia A. Stubbs – The U.S. District Court for the Central District of California issued a ruling last week in an unusual, if not unprecedented, case arising from alleged federal False Claims Act (“FCA”) violations where one drug manufacture has sued its competitor. In Amphastar …
By Ricardo Carvajal – The U.S. District Court for the Northern District of California granted summary judgment to the Center for Food Safety and Center for Environmental Health in their lawsuit (see our previous post here) alleging that FDA’s delay in issuing regulations to implement …
By Jennifer D. Newberger – FDA is proposing to amend the medical device labeling requirements to allow for use of internationally recognized stand-alone symbols explained in an accompanying symbols glossary. The symbols glossary would include a list of each symbol used in the device labeling and …
By Ricardo Carvajal – FDA reportedly intends to extend the comment period on the preventive controls and produce safety proposed rules by an additional 120 days (the comment period was scheduled to expire on May 16). The extension was requested in a letter by the …
By Riëtte van Laack – As previously discussed, in 2011, the FTC filed an action against Garden of Life and its owner (collectively “GOL”) asking the District Court to order GOL to show cause why it should not be held in civil contempt. The case stems …
By Jeffrey K. Shapiro & Jennifer D. Newberger – The medical device appeals process has long been in need of improvement. See our previous posts here and here. There are several ways an entity can appeal a decision of the Center for Devices and Radiological Health …
By Ricardo Carvajal – Our colleagues at the Drug and Device Law Blog recently blogged on the decision in Wilson v. Frito-Lay North America, Inc., a false advertising case out of the Northern District of California in which the court held that statements on a food …
By Kurt R. Karst – The cherry blossoms are finally in full bloom in Washington, D.C., and so too is FDA’s thinking on one non-abuse-deterrent drug. In a prepublication version of a notice that will be published in the Federal Register on April 18, 2013, …
By Karla L. Palmer & Jeffrey N. Gibbs – On April 10, 2013, the Department of Health and Human Services’ Office of Inspector General (“OIG”) released a Memorandum Report titled, “High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them.” The OIG Report provides …
As it does every spring, the Federal Trade Commission (“FTC”) has released its annual report. The new report, which covers 2012, makes clear that the FTC remains as focused as ever on health-related advertising – especially where advertising allegedly promotes products for weight loss or …
By Kurt R. Karst – “GADPTRA” – Now there’s an acronym you don’t see very often on this blog. It stands for the Generic Animal Drug and Patent Term Restoration Act of 1988, Pub. Law No. 98-417, 98 Stat. 1585 (1988), which is the Hatch-Waxman …
By Karla L. Palmer & Jeffrey N. Gibbs – On Thursday, April 11, 2013, FDA published a statement titled, “2013 FDA Pharmacy Inspection Assignment,” addressing the unprecedented recent nationwide wave of aseptic pharmacy inspections. The Agency states that it had taken critical look at its …
By Kurt R. Karst – Earlier this week, the Obama Administration released the President’s Budget for Fiscal Year 2014. At first blush, FDA appears to have fared rather well, with an additional $821,453,000 in total funding. Most of the increase, however, is due to new …
By Riëtte van Laack – On March 28, U.S. District Court Judge Richard Seeborg of the Northern District of California entered summary judgment for the defendants in a 2010 class-action lawsuit which had alleged that defendants misrepresented AriZona Iced Tea beverages containing “man-made” citric acid and …
By Kurt R. Karst – As food and drug attorneys, we rely on a certain level of FDA transparency to understand why FDA did what it did in a particular case, and to discern what that means for future Agency action (or inaction) in another …
