By John R. Fleder – Lawyers are often asked if a client can be sued if the client does something. Almost without exception, the answer is yes. It does not take much for a person to file a lawsuit in court without much or any evidence, …
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Prescription Drugs and Biologics
- Is Anyone Safe From an FCA Whistleblower Suit?January 14th, 2015
- District Court Sides with FDA, 505(b)(2) Applicant in Challenge to Colchicine Capsules Approval; An Appeal is in the Works, HoweverJanuary 13th, 2015
By Kurt R. Karst – A little over three months ago, we on a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction Takeda Pharmaceuticals U.S.A., Inc.’s (“Takeda”) filed against FDA in the U.S. District Court for the District of Columbia challenging the …
- Novartis’s Biosimilar of Neupogen Clears a Big Hurdle, But Major Issues Remain for it and Other BiosimilarsJanuary 12th, 2015
By James C. Shehan – FDA’s Oncologic Drugs Advisory Committee unanimously voted in favor of approval of EP2006, Novartis’s biosimilar version of Amgen’s Neupogen® (filgrastim) for all five of the indications for which Neupogen is approved. This ground-breaking event manages to both move the US a …
- U.S. Supreme Court is Asked to Review First-in-the-Nation Safe Drug Disposal OrdinanceJanuary 6th, 2015
By Kurt R. Karst – Late last month, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) jointly filed a Petition for a Writ of Certiorari (Case No. 14-751) with the U.S. Supreme Court asking the …
- Convergence: Recent Court Actions and Pressure From FDA May Mean the Sun is Finally Setting on the Premature Paragraph IV Notice StrategyJanuary 5th, 2015
By Kurt R. Karst – It’s been many months since we last posted on the issue of so-called “premature notice” (and over a year since we first posted on the issue). Premature notice is notice – ineffective notice – of a Paragraph IV certification sent to …
- New Jersey District Court Issues First Written Opinion in REMS Antitrust Litigation Involving ANDA Biostudy Sample ProcurementJanuary 4th, 2015
By Kurt R. Karst – In what is, to our knowledge, a first-of-its-kind written decision, Judge Esther Salas of the U.S. District Court for the District of New Jersey issued an Oral Opinion and Order on December 22, 2014 granting without prejudice in part and denying …
- FTC Issues First Post-Actavis Staff Report on Drug Patent Settlement Agreements; No Meaningful Conclusions on the Effects of Actavis Decision Can Yet Be DrawnDecember 28th, 2014
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced the issuance of the Bureau of Competition’s annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2013) – Agreements Filed with the Federal Trade Commission under the …
- In Keeping With the Spirit of the Season, FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace RequirementsDecember 26th, 2014
By Anne Marie Murphy – On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act ("DSCSA") prior to May 2015. The guidance, states in relevant part: FDA recognizes that …
- FDA Issues Post-Depomed Policy Statement; Agency Doubles Down on Clinical Superiority RequirementDecember 22nd, 2014
By Kurt R. Karst & Michelle L. Butler – Ever since FDA withdrew a notice of appeal in Depomed Inc. v. U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592, to the U.S. Court of Appeals for the District of Columbia Circuit (see …
- Deliverance: FDA is Sued Over the Applicability of 3-Year Exclusivity in the Context of Dueling Tacrolimus NDAs; Agency Gets a Short Reprieve to Make a Final DecisionDecember 18th, 2014
By Kurt R. Karst – Queue up the dueling banjo scene from the film Deliverance. . . . Early last month we saw an interesting press release from Veloxis Pharmaceuticals, Inc. (“Veloxis”) announcing FDA’s October 30, 2014 tentative approval of the company’s 505(b)(2) NDA 206406 for ENVARSUS …
- The Proposed NIH Framework for Clinical Trials Registration and Results Reporting: A Closer LookDecember 18th, 2014
By James E. Valentine* & Anne Marie Murphy – As we previously reported, last month the National Institutes of Health (“NIH”) published a Notice of Proposed Rulemaking on clinical trials registration and results submission (“NPRM”), and is requesting public comment by February 19, 2015. The NPRM generally …
- Fourth Circuit Rolls Back District Court Decision on Pre-MMA 180-Day Exclusivity for Generic CELEBREXDecember 17th, 2014
By Kurt R. Karst – December 16th was a good day for Hyman, Phelps & McNamara, P.C. We learned that the U.S. Court of Appeals for the Fourth Circuit handed our client, Mylan Pharmaceuticals, Inc. (“Mylan”), a significant victory. In a 3-0 panel decision (Circuit Judges …
- Main Street Family Pharmacy Compounder Pleads Guilty to Misdemeanor Violations of the FDCA, and Accepts Probation, a $25,000 Fine and a Permanent InjunctionDecember 15th, 2014
By Karla L. Palmer – On December 4, 2014, in the United States District Court for the District of Tennessee, Main Street Family Pharmacy, LLC and its co-owner David Newbaker each pled guilty to a misdemeanor criminal violation of the Federal Food, Drug, & Cosmetic Act …
- Expansion of Expanded Access? Federal Right to Try Legislation is IntroducedDecember 10th, 2014
By James C. Shehan – Over the past year, the plight of seriously ill patients seeking access to unapproved drugs has led five states to pass laws that permit manufacturers to provide patients in those states with investigational drugs on an emergency basis without going through …
- Third Circuit Kicks OPANA ER Therapeutic Equivalence Rating Lanham Act Case Back to District CourtDecember 8th, 2014
By Kurt R. Karst – 'Tis the season to give back. And that’s exactly what the U.S. Court of Appeals for the Third Circuit did late last week when it vacated and remanded for further proceedings a September 3, 2013 decision from the U.S. District Court …