By William T. Koustas – We have previously reported (here and here for example) on the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA. Regenerative is a Colorado company that owns a medical procedure known as the Regenexx Procedure. It is a non-surgical procedure by …
By Kurt R. Karst – Anyone from the United States who has visited a foreign city – like São Paulo, Brazil or Mumbai, India – knows immediately upon exiting the sealed environment of their aircraft that they are no longer in the United States. There’s …
By Kurt R. Karst – FDA’s latest Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience with so-called “505(q) citizen petitions” during Fiscal Year 2012 (“FY2012”) is largely a rehash of the FY2011 Report to Congress (see our previous post here on …
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 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 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 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 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 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 – 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 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 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 …
By Kurt R. Karst – Last Friday, Representative Jason Chaffetz (R-UT) introduced H.R. 2985, the Combination Drug Development Incentive Act of 2013. The bill would amend the 5-year New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act that affect the submission and approval of …
