By Ricardo Carvajal – Is the word “source” (just “source” – not “good source” or “excellent source”) a nutrient content claim? FDA seems to think so, as reflected in a paragraph in this warning letter that escaped our attention when it issued in March 2011. FDA …
By Kurt R. Karst – Public shaming has been used as a type of punishment for centuries and has taken on many forms. In Colonial America, for example, physical forms of shaming and humiliation like stocks and pillory were common. And who could forget Nathaniel …
By Kurt R. Karst – In June 2013, FDA announced the issuance of a draft guidance document, titled “Expedited Programs for Serious Conditions – Drugs and Biologics” (Docket No. FDA-2013-D-0575). As we previously reported, the draft guidance, as well as a related Manual of Policies …
By Kurt R. Karst – Earlier this year, FDA’s Dallas District Office issued a Warning Letter to Sovereign Pharmaceuticals, LLC (“Sovereign”), a pharmaceutical contract manufacturing facility located in Fort Worth, Texas, containing a rather interesting – and quite perplexing – violation tagged under the heading “Unapproved …
By Kurt R. Karst – If you wait around long enough, almost any scenario feasible under the FDC Act with respect to Hatch-Waxman exclusivity is bound to happen. Nearly six years after the September 2007 enactment of the FDA Amendments Act (“FDAAA”), one company’s drug …
By John A. Gilbert – Earlier this week, Eisai, Inc. (“Eisai”) filed a Petition for A Writ of Mandamus in the U.S. Court of Appeals for the District of Columbia Circuit to force the Drug Enforcement Administration (“DEA”) to issue a Notice of Proposed Rulemaking (“NPRM”) …
By Ricardo Carvajal – In poring over FDA’s recently issued proposed rule on Accreditation of Third Party Auditors (see our prior post here), one thing that caught our eye is FDA’s discussion of FSMA’s notification requirement for auditors. That requirement is embedded in new § 808(c)(4) …
By Riëtte van Laack – In March 2013, the nearly three-year battle between POM Wonderful and the FTC that was fought at the FTC moved to the United States Court of Appeals for the D.C. Circuit (see our previous posts here and here). Following several extensions …
By Kurt R. Karst – Late last week, the Federal Trade Commission (“FTC”) announced that it had filed a motion asking the U.S. District Court for the District of New Jersey to accept an amicus brief in In re Effexor XR Antitrust Litigation concerning the …
By Jennifer D. Newberger – An increasing number of devices employ radio frequency wireless technology. This trend is likely to continue. These devices present some new technological issues. To respond to these new issues, FDA has just released a draft guidance titled, “Radio Frequency Wireless …
By Wes Siegner – In response to a history of FDA illegal restriction of the marketing of dietary supplements in the 1980s and early 1990s, Congress amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”), passing by unanimous consent the Dietary Supplement Health and Education …
By Etan Yeshua – Earlier this week, FDA provided new insight into its interpretation of the definition and regulation of medical foods — a legal category established by the Orphan Drug Act of 1988, incorporated into the Federal Food, Drug, and Cosmetic Act in 1990, and …
By Ricardo Carvajal – Fred Kummerow, a Professor Emeritus at University of Illinois, sued FDA for failing to respond to his citizen petition (Docket No. FDA-2009-P-0382) asking the agency to ban partially hydrogenated oils containing artificial trans fat. The citizen petition was submitted in August …
By Anne K. Walsh – Refusing to give up his fight to overturn his felony conviction, the former CEO of InterMune Inc., Dr. Scott Harkonen, recently filed a petition asking the U.S. Supreme Court to review his case. Harkonen asserts that the government violated his …
By Kurt R. Karst – Five-year New Chemical Entity (“NCE”) exclusivity issues are hot – really HOT – these days! Not only are there three Citizen Petitions pending at FDA requesting that the Agency interpret the FDC Act to grant 5-year exclusivity for a fixed-dose …
