By David B. Clissold – Last week, House Democrats and a consortium of public health organizations turned up the heat on FDA to issue “deeming” regulations that would bring electronic cigarettes and other types of tobacco products under the Agency’s jurisdiction. The Family Smoking Prevention and …
By Kurt R. Karst – The titles – and sometimes even the content – of some of our posts are inspired by the things we experience (or have experienced) in our regular, non-attorney lives. For years now we’ve weaved together with food and drug law …
By Wes Siegner & Paul M. Hyman – The term “medical food” was first defined by statute in the Orphan Drug Act Amendments of 1988. The medical food category is closely related to the already existing category of “foods for special dietary use,” authorized by …
By Riëtte van Laack – As previously reported here, in July, the American Meat Institute and several international meat industry organizations filed a lawsuit in an effort to stop the Agricultural Marketing Service ("AMS") of the USDA from implementing the Country of Origin Labeling ("COOL") rule, …
By Etan J. Yeshua – Three months after announcing a strategic research plan to support its regulatory agenda, FDA's Center for Food Safety and Applied Nutrition ("CFSAN") this week announced its regulatory priorities for 2013 and 2014, giving those in the food, dietary supplement, and cosmetic …
By Delia A. Stubbs – As previously reported, the Physicians for Responsible Opioid Prescribing (“PROP”) filed a Citizen Petition in March requesting that FDA limit the labeling of “controlled release” opioids to severe-only pain in non-cancer patients. The petition also requested that FDA impose certain …
By Kurt R. Karst – In the 1992 movie A Few Good Men, military lawyer Lt. Daniel Kaffee (played by Tom Cruise) handles the court martial of two U.S. Marines charged with the murder of a fellow Marine. The Marines contend they were acting under …
By Allyson B. Mullen – Earlier this summer, CDRH issued a new Draft Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (the “Draft Guidance”). We have previously posted on the Draft Guidance here. As noted in our earlier post, …
By Kurt R. Karst – Earlier this week, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), along with several other trade groups – the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and Retail Association of Maine – and two pharmacists, filed a Complaint and …
By Jeffrey N. Wasserstein and Alexander J. Varond – On September 11, 2013, Adheris, Inc. (“Adheris”) and the Department of Health and Human Services (“HHS”) filed a joint motion requesting the suspension of Adheris’s motion for a preliminary injunction seeking to prohibit HHS from enforcing its …
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. …
