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. …
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 – 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 …
The American Conference Institute (“ACI”) will be holding two events in the coming months that are of particular interest to FDA Law Blog readers. . . . and, importantly, for which our readers can get a discount. The first event is ACI’s Legal, Regulatory, and …
By Kurt R. Karst – Now that we've put the theme from The Jeffersons in your head . . . . On August 2, 2013, FDA will officially announce in a series of Federal Register notices the Fiscal Year 2014 (“FY 2014”) user fee rates under …
By Kurt R. Karst – A series of decisions handed down earlier this week by Judge Mary Jane Bowes of the Superior Court of Pennsylvania arising from mass tort litigation in Philadelphia County involving REGLAN (metoclopramide) and its generic versions can only be drescibed as …
