By James R. Phelps – George Miller Burditt died on March 13, 2013 following a heart attack. He was 90 years of age. With his passing the food and drug bar lost one of its most distinguished members. People were drawn to George by his friendly, …
By Alexander Varond – On March 12, 2013, FDA released a draft version of a revision to the February 2000 final guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level.” We refer to the draft version as “Revision 1.” Revision 1 retains the original …
By Kurt R. Karst – Briefing is underway in K-V Pharmaceutical Company’s (“KV’s”) appeal of a September 2012 decision from the U.S. District Court for the District of Columbia that stymied the company’s efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA …
By Carmelina G. Allis – With information technology taking on an increasingly important role in the healthcare system, software app developers are focusing their efforts on developing programs intended to facilitate health, wellness, and disease management. Some of these apps are developed for and implemented …
By Kurt R. Karst – We thought it would only be a matter of time until the Federal Trade Commission (“FTC”) decided to voice its views in a lawsuit filed last September by Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) in the …
By Karla L. Palmer – The National Association of Attorneys General (“NAAG”) today sent a letter to the U.S. Food and Drug Administration’s Margaret Hamburg urging the Agency to adopt standards requiring manufacturers and marketers of generic prescription opioids to develop tamper-resistant versions of such products. …
By Ricardo Carvajal – FDA recently denied a citizen petition (Docket No. FDA-2011-P-0484) that asked the agency to take numerous actions with respect to mercury in commercial fish. In part, the petition asked FDA to establish an action level, regulatory limit, or tolerance of 0.5 ppm (the …
Many of us at Hyman, Phelps & McNamara, P.C. will miss a cherished former colleague and worthy opponent: Rick Blumberg, the Deputy Chief Counsel for Litigation at FDA, who died Thursday, March 7th, of complications from a stroke. He handled litigation for FDA for more …
By Carmelina G. Allis – On February 28, 2013, FDA’s Center for Devices and Radiological Health (“CDRH”) issued what appears to be an unprecedented joint FDA/Federal Trade Commission “untitled letter” in the form of an email (an “untitled email”) to on-line distributors of decorative contact …
By Kurt R. Karst – Earlier ths week, Apotex Corp., Roxane Laboratories, Inc., and Actavis Elizabeth LLC (collectively “Counterclaim Plaintiffs”) filed their opposition to Actelion Pharmaceuticals Ltd.’s and Actelion Clinical Research, Inc.’s (collectively “Actelion’s”) Motion for Judgment on the Pleadings and to Dismiss Counterclaims in …
By Anne K. Walsh – On March 4, 2013, less than three months after oral argument, the Ninth Circuit issued its ruling in United States v. Harkonen, a closely watched case implicating First Amendment issues in the off-label promotion context. As we previously reported (here …
By Ricardo Carvajal – The Notification of Opportunity to Initiate a Voluntary Recall that FDA recently issued to a pet treat manufacturer gives a good indication of the type of evidence and circumstances that can prompt the agency to exercise its new mandatory recall authority. Before …
By Kurt R. Karst – Finally! A Hatch-Waxman lawsuit that is not overly complex and not difficult to unravel. Late last week, Sun Pharma Global FZE, Caraco Pharmaceutical Laboratories, Ltd., and Sun Pharmaceuticals Industries, Ltd. (collectively “Sun”) filed a Complaint and a Motion for a …
By Jeffrey K. Shapiro – FDA has just issued a draft guidance document titled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements” (Docket No. FDA-2013-D-0114) intended to clarify how to distinguish product “corrections” from product “enhancements.” Although the draft guidance would be applicable …
An article published by Law360 and co-authored by H. Keeto Sabharwal and Dennies Varughese of Sterne Kessler Goldstein & Fox PLLC, and Kurt R. Karst of Hyman Phelps & McNamara PC, examines whether, and to what extent, a successful Inter Partes Review (“IPR”) challenge by a …
