By Kurt R. Karst – Earlier this week, Representative Robert Hurt (R-VA) introduced new legislation – H.R. 3631, the Small Manufacturer Protection Act of 2013 – that, if enacted, would bring relief to some companies that are required to pay user fees under the Generic Drug …
By Kurt R. Karst – The number of citizen petitions pending at FDA concerning Hatch-Waxman exclusivity continues to pile up. As we previously reported (here and here), FDA has already been asked on three separate occasions in 2013 to recognize 5-year New Chemical Entity (“NCE”) exclusivity …
By Kurt R. Karst – “Oddities” are not the sole domain of the world of antiques and other rarities (for those of you who are fans of the television show that focuses on the day-to-day operation of Obscura Antiques & Oddities). Food and drug law – …
By Kurt R. Karst – In what appears to be the first dismissal (Docket No. FDA-2012-E-0491) of a Patent Term Extension (“PTE”) application in what has been referred to as a “reverse Photocure” scenario, the Patent and Trademark Office (“PTO”) has determined that U.S. Patent No. …
By Jennifer M. Thomas – The generic drug industry has waited with bated breath since, as we reported here and here, FDA signaled that it was “considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.” See …
By Kurt R. Karst – Earlier this week, sanofi-aventis U.S., LLC (“Sanofi”) filed a Complaint in the U.S. District Court for the District of Columbia against FDA in what appears to be a first-of-its-kind lawsuit. Sanofi alleges that FDA’s decision to make public a copy of …
By Kurt R. Karst – The Generic Pharmaceutical Association (“GPhA”) held its annual Fall Technical Conference this week. There were lots of interesting topics on the conference agenda, such as complex drugs, ANDA filing and refuse-to-receive issues (see the recent FDA guidance here), adverse event …
By Kurt R. Karst – In a decision handed down on September 30, 2013 (but not unsealed until last Friday), the U.S. District Court for the District of Columbia rebuffed a challenge by Cumberland Pharmaceuticals Inc. (“Cumberland”) to FDA’s approval of a generic version of Cumberland’s acetaminophen …
By Kurt R. Karst – FDA’s recent response to two Citizen Petitions (Docket Nos. FDA-2013-P-0995 and FDA-2011-P-0869) helped to shed some additional light on an issue that continues to vex companies considering submitting a 505(b)(2) NDA to FDA for a new drug: When do I …
By Kurt R. Karst – We’ve previously noted the resurgence of interest in (and controversy over) brand-side exclusivity. There’s the QI Program Supplemental Funding Act of 2008 (Pub. L. No. 110-379), which gave new life to “old” antibiotics. FDC Act § 505(u), titled “Certain Drugs …
By Kurt R. Karst – We’re now entering the second week of the shutdown of the federal government (or “the lapse period” as some have called it), and there does not appear to be an end in sight. In fact, the environment in Washington, D.C. has …
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 – 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 – 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. …
