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 …
Menu
Hatch-Waxman
- The Shutdown: An Update on FDA ActivitiesOctober 7th, 2013
- Money Has a Way of Changing People: The UFAization of FDA’s Office of Generic DrugsSeptember 26th, 2013
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 …
- FDA’s Fifth Annual Report to Congress on 505(q) Citizen Petitions: Something Old, Something New, Something Borrowed, FDA is Still BlueSeptember 25th, 2013
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 …
- “You Can’t Handle the Truth!” Code Orange: Court Dismisses Lanham Act-Orange Book Therapeutic Equivalence Rating Complaint on Primary Jurisdiction GroundsSeptember 15th, 2013
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 …
- The Biosimilars State Legislation ScorecardSeptember 4th, 2013
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. …
- Public Shaming: FDA Edges Closer to Citizen Petition Denial for Intent to Delay Generic Drug Approval, But Prefers to Pass the Buck on EnforcementAugust 28th, 2013
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 …
- First Post-FDAAA “New Active Ingredient” Election and Grant of NCE Exclusivity Made With the Approval of FETZIMAAugust 25th, 2013
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 …
- FTC Seeks to File (Again) Amicus Brief in EFFEXOR XR “No-AG” Agreement Antitrust Case; Plaintiffs in Similar LAMICTAL Case Seek Reconsideration of DismissalAugust 20th, 2013
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 …
- Eisai Says FDA Erroneously Triggered NCE Exclusivity Start Dates Before DEA Controlled Substance Scheduling Permitted MarketingAugust 11th, 2013
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 …
- New Legislation Seeks to Provide 5-Year NCE Exclusivity For Certain Combination DrugsAugust 5th, 2013
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 …
- ACI’s 2nd Annual Over-the-Counter Drugs Forum & Inaugural Paragraph IV Disputes Master SymposiumAugust 4th, 2013
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 …
- FDA Announces Fiscal Year 2014 User Fee Rates; They’re Movin’ On Up!August 1st, 2013
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 …
- Superior Court of Pennsylvania Delivers Quadruple Whammy in Metoclopramide Failure-to-Warn Preemption Decisions; Gives RLD Theory of Liability Some LegsJuly 30th, 2013
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 …
- FDA Resolves 180-Day Exclusivity Forfeiture for Tentative Approvals that Occur on the 30-Month ANDA Submission Anniversary DateJuly 25th, 2013
By Kurt R. Karst – FDA’s recent approval of Caraco Pharmaceutical Laboratories, Ltd.’s (“Caraco’s”) ANDA No. 077571 for a generic version of PRANDIN (repaglinide) Tablets is interesting on several fronts. For starters, it is the ANDA at the heart of the U.S. Supreme Court’s decision …
- A Punt Return, Not a Fumble Return, in the Second FDA Resolution of a 180-Day Exclusivity Punt CaseJuly 15th, 2013
By Kurt R. Karst – Touchdown! It was just last month that we posted on the first instance in which FDA resolved what has become known as a “180-day exclusivity punt.” As we explained then, “180-day exclusivity punts” are instances in which a first applicant eligible …