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 …
Menu
Prescription Drugs and Biologics
- “You Can’t Handle the Truth!” Code Orange: Court Dismisses Lanham Act-Orange Book Therapeutic Equivalence Rating Complaint on Primary Jurisdiction GroundsSeptember 15th, 2013
- Not In Our Backyard! Pharmacists and Trade Groups Sue to Block Implementation of Maine Drug Importation LawSeptember 12th, 2013
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 …
- 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. …
- Alameda County Drug Take-Back and Disposal Ordinance Not Unconstitutional Says Federal JudgeSeptember 3rd, 2013
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 …
- 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 …
- Lifting the Veil on FDA Subpart H Surrogate Endpoint ApprovalsAugust 27th, 2013
By Kurt R. Karst – In June 2013, FDA announced the issuance of a draft guidance document, titled “Expedited Programs for Serious Conditions – Drugs and Biologics” (Docket No. FDA-2013-D-0575). As we previously reported, the draft guidance, as well as a related Manual of Policies …
- 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 …
- GAO Report on Drug Compounding: Lack of Both Clear Authority and Reliable Data Compounds FDA’s Inability to ActAugust 4th, 2013
By Karla L. Palmer – The General Accountability Office (“GAO”) recently released its Report on Drug Compounding as Congress faces dueling compounding bills in the Senate (S. 959, Pharmaceutical Compounding Quality and Accountability Act, sponsored by Sen. Tom Harkin) and the House of Representatives ( H.R. …
- 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 …
- Breakthrough Therapy Designation: Stakeholders Discuss the Program One Year LaterJuly 28th, 2013
By James E. Valentine* & Alexander J. Varond – Since the breakthrough therapy designation came into existence a year ago, drug companies (and their investors) have been trying to figure out the value of the program. The designation was initially proposed as a way to …