By Jennifer D. Newberger – The Food and Drug Administration Safety and Innovation Act (“FDASIA”), signed into law in July 2012, requires the Secretary of Health and Human Services (“HHS”) to “post a report—within 18 months (or by January 2014)—that contains a proposed strategy and recommendations …
By Jeffrey N. Wasserstein & Alexander J. Varond – Several months ago, when HHS released the final HITECH rule, we noted that several of the provisions represented a sea change from prior practice (see our previous post here). Well, the seas have gotten rougher and …
By Jeffrey K. Shapiro – In 2012, the U.S. Supreme Court held that agency regulations and enforcement policy violate due process if they do not provide fair notice of what is prohibited or required, or are so standardless that they permit seriously discriminatory enforcement. FCC v. …
By Allyson B. Mullen – On August 28, 2013, FDA’s Center for Devices and Radiological Health issued a draft guidance, “The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers.” This new, short guidance restates the requirements of the Good Laboratory Practices …
By Kurt R. Karst – We present to you the Biosimilars State Legislation Scorecard. Links are provided to each piece of legislation. We also give you a word or two on status. In most cases, a summary of each bill is provided at the linked-to website. …
By Ricardo Carvajal – In a number of recent class actions, a central allegation has been that a marketer misled consumers by labeling as “all natural” a food that contains a genetically modified organism ("GMO"). Defendants usually invoke the doctrine of primary jurisdiction in an …
By Kurt R. Karst – Last week, Judge Richard Seeborg of the U.S. District Court for the Northern District of California issued an 11-page ruling in a lawsuit filed in December 2012 by the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and …
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 …
