By Kurt R. Karst – Over the past year or so, we’ve seen a change in FDA policy concerning what approvals the sponsor of a 505(b)(2) NDA can cite in an application; that is, what previous FDA approvals a 505(b)(2) sponsor can rely on for the …
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Hatch-Waxman
- When Can’t a “Listed Drug” Serve as a Reference Product for a 505(b)(2) Application?June 19th, 2012
- New Study Examines Citizen Petitions; Concludes that Petitions are on the Rise and that 505(q) Has Been UnsuccessfulJune 17th, 2012
By Kurt R. Karst – A new article, titled “Citizen Petitions: An Empirical Study,” analyzes citizen petitions submitted to FDA between 2001 and 2010 and concludes that petitions submitted to FDA concerning drug products are on the rise and show no signs of abating. The paper, …
- “Bring Out Your Dead” Says OGD in a Pre-GDUFA House Cleaning Move as the Agency Prepares for ANDAgeddonJune 13th, 2012
By Kurt R. Karst – In a move that brings to mind Scene 2 of Monty Python and the Holy Grail, in which a mortician roams the streets ringing a bell and calling out “Bring out your dead!” (a close second being the Monty Python “Dead …
- FTC Commissioner Objects to Certain Provisions in Senate FDA User Fee Reauthorization LegislationJune 5th, 2012
By Kurt R. Karst – As the U.S. Senate and U.S. House of Representatives geared up last month to consider bills in their respective chambers to, among other things, reauthorize and amend old and establish new user fee statutes, one FTC Commissioner – Commissioner J. Thomas …
- House Passes FDA Reform Act of 2012; Next Up – Conference CommitteeMay 31st, 2012
By Kurt R. Karst – After a round of congratulatory speeches, the U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. Unlike the U.S. Senate, which passed its version of the bill …
- Pennsylvania District Court Issues an XL Decision in WELLBUTRIN XL Antitrust, Sham Citizen Petition CaseMay 30th, 2012
By Kurt R. Karst – In a recent, 95-page decision from the U.S. District Court for the Eastern District of Pennsylvania in In re Wellbutrin XL Antitrust Litigation, the court once again tackled the issues of “sham” citizen petitions, liability under the Sherman Antitrust Act, and …
- Making the House FDA Reform Act of 2012 PAYGO Compliant – Are Expedited 505(q) Citizen Petition Responses the Answer?May 28th, 2012
By Kurt R. Karst – We’re not economists, but we’re interested in the topic insofar as it concerns Congress’ consideration of FDA-related legislation, such as H.R. 5651, the FDA Reform Act of 2012, which is on tap for consideration by the U.S. House of Representatives later …
- U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House BillMay 25th, 2012
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
- FDA’s PLAIR Program Collides With Hatch-WaxmanMay 23rd, 2012
By Kurt R. Karst – FDA’s recent approval of ANDAs for generic versions of sanofi-aventis’ (“sanofi’s”) blockbuster blood thinner drug PLAVIX (clopidogrel bisulfate) Tablets (approved under NDA No. 020839) upon the May 17, 2012 expiration of a period of pediatric exclusivity associated with Orange Book-listed U.S. Patent …
- Decisions, Decisions, Decisions! Our Updated Labeling Carve-Out Citizen Petition ScorecardMay 16th, 2012
By Kurt R. Karst – A lot has happened since we last updated our Generic Drug Labeling Carve-Out Citizen Petition Scorecard in October 2011. At that time, AstraZeneca had only recently submitted two citizen petitions concerning quetiapine fumarate (SEROQUEL and SEROQUEL XR). Petitions, FDA decisions, lawsuits, …
- Defendants Rack Up Another State Court Win in Mensing and RLD Liability Theory DecisionsMay 8th, 2012
By Kurt R. Karst – Following the recent decision by the U.S. Court of Appeals for the First Circuit in Bartlett v. Mutual Pharmaceutical Co., which our friends over at the Drug and Device Law Blog commented on as making no sense (“while a simple warning …
- Updated House Energy & Commerce UFA Bill Would Shorten FDA’s 505(q) Petition Response Timeframe; Require Timely Responses to RLD Withdrawal PetitionsMay 7th, 2012
By Kurt R. Karst – On Tuesday, May 8th, the House Energy and Commerce Committee, Subcommittee on Health is scheduled to hold a markup session to consider draft legislation to ensure the continuation of existing FDA user fee programs (i.e., PDUFA and MDUFA) and the creation …
- Eleventh Circuit Rules Against the FTC in ANDROGEL Patent Settlement Appeal; Sen. Bingaman Pushes for Legislative RemedyApril 30th, 2012
By Kurt R. Karst – In yet another decision out of the U.S. Court of Appeals for the Eleventh Circuit concerning patent settlements (or what opponents refer to as "pay-for-delay" deals), the Court affirmed a February 2010 decision by the U.S. District Court for the …
- Senate and House Bills Seek to Legislatively Overturn the Supreme Court’s Mensing DecisionApril 19th, 2012
By Kurt R. Karst – Carrying through on his promise to introduce legislation to legislatively overturn the U.S. Supreme Court’s June 23, 2011 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), Senator Patrick Leahy (D-VT), along with co-sponsor Sens. Al Franken (D-MN), Jeff …
- Absolutely, Totally, and in All Other Ways Inconceivable? Nope, Says the Federal Circuit in YASMIN Hatch-Waxman Method Patent LitigationApril 18th, 2012
By Kurt R. Karst – In a 2-1 panel decision handed down by the U.S. Court of Appeals for the Federal Circuit earlier this week, the Court affirmed a September 2010 Judgment on the Pleadings by the U.S District Court for the Southern District of New …