By Kurt R. Karst – Section 11 of the Best Pharmaceuticals for Children Act (“BPCA”) of 2002 amended the FDC Act to add a new provision, which was reauthorized under the FDA Amendments Act of 2007 and is located at FDC Act § 505A(o), to …
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Hatch-Waxman
- BPCA Section 11 and Pediatric Labeling; Revised Labeling Carve-Out Citizen Petition ScorecardJune 22nd, 2009
- Will FDA Apply a Presumption in Favor of NCE Status for Pancreatic Enzyme Products?June 16th, 2009
By Kurt R. Karst & Frank J. Sasinowski – FDA’s recent decision to approve the Pancreatic Enzyme Product (“PEP”) CREON (pancrelipase) to help patients with cystic fibrosis and others with Exocrine Pancreatic Insufficiency (“EPI”) digest and absorb nutrients from foods has apparently left the Agency …
- FDA’s Holding-on-the-Merits Standard – Will it Apply Post-MMA?June 14th, 2009
By Kurt R. Karst – Will FDA apply the Agency’s pre-Medicare Modernization Act (“MMA”) “holding-on-the-merits standard” to the post-MMA “failure to market” 180-day exclusivity forfeiture provisions? It is a reasonable question, and one that FDA has not yet definitively answered. Nevertheless, there appears to be …
- FTC Issues Highly Anticipated Report on Follow-On Biologics; Report Concludes that Special Legislative Exclusivity Incentives are Largely Unwarranted for Innovators and GenericsJune 10th, 2009
By Kurt R. Karst – On June 10th, the Federal Trade Commission (“FTC”) announced the release of its highly anticipated report on Follow-On Biologics (“FOBs”). The 120-page report, titled “Emerging Health Care Issues: Follow-On Biologic Drug Competition” is the product of an FTC Roundtable held …
- Multiple PTEs; Federal Circuit Decision in Generic OMNICEF Litigation Puts the Issue on Hold for Another DayJune 8th, 2009
By Kurt R. Karst – The U.S. Court of Appeals for the Federal Circuit’s recent decision in Abbott Labs. v. Sandoz, Inc. concerning U.S. Patent No. 4,935,507 (“the ‘507 patent”) covering OMNICEF (cefdinir) has been discussed at length in the blogosphere for its possible implications …
- Galderma Submits New QI Act 30-Month Stay Citizen Petition; a New Variation on an Old ThemeJune 4th, 2009
By Kurt R. Karst – Galderma Laboratories L.P. (“Galderma”) recently submitted a citizen petition to FDA (also see our Citizen Petition Tracker) requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”) to impose a 30-month stay of approval of …
- PhotoCure and Wyeth District Court PTE Decisions Appealed to the Federal Circuit; Effects of the PhotoCure Decision are Already EvidentJune 4th, 2009
By Kurt R. Karst – Recent decisions by the U.S. District Court for the Eastern District of Virginia and the U.S. District Court for the District of Columbia in PhotoCure ASA v. Dudas and Wyeth Holding Corp. v. United States, respectively, concerning certain Patent Term Extension …
- Apparently Tired of Waiting for an FDA Opinion, GSK Submits Drug Delivery Patents to FDA for Orange Book ListingMay 28th, 2009
By Kurt R. Karst – The recent addition of numerous patents to the Orange Book covering various GlaxoSmithKline (“GSK”) drug products, such as VENTOLIN (albuterol sulfate), FLOVENT (fluticasone propionate), ADVAIR (fluticasone propionate; salmeterol xinafoate), and SEREVENT (salmeterol xinafoate), begs the question why? Many of the new patent …
- WLF Legal Backgrounder Discusses PDUFA User Fee “Catch-22;” FDA’s ANDA “Non-Exception Excipient” Regulations and Policies Taken to TaskMay 21st, 2009
By Kurt R. Karst – The Washington Legal Foundation is publishing a Legal Backgrounder authored by Hyman, Phelps & McNamara, P.C., attorneys Robert A. Dormer and Kurt R. Karst. The article, titled “The Drug User Fee Catch-22,” argues that FDA should be more flexible in receiving and …
- Stereoisomer Orphan Drug “Sameness” – Another Interesting Counterpoint to FDA’s First Permitted Commercial Marketing or Use PTE DeterminationsMay 14th, 2009
By Kurt R. Karst & Frank J. Sasinowski – Earlier this week, we posted on a recent district court decision affirming the validity of a Patent Term Extension (“PTE”) for a patent covering an enantiomer of a previously approved racemate. The court’s decision relied heavily on …
- NJ District Court Affirms Enantiomer PTE Validity; Decision Quickly Appealed to the Federal CircuitMay 12th, 2009
By Kurt R. Karst – In a recent unpublished opinion issued by the U.S. District Court for the District of New Jersey, the court ruled that the Patent Term Extension (“PTE”) granted by the U.S. Patent and Trademark Office (“PTO”) with respect to U.S. Patent No. …
- FDA Petition Response Reaffirms FDA Orange Book Dosage Form Nomenclature PolicyMay 6th, 2009
By Kurt R. Karst – FDA’s recent decision to grant in part and deny in part a citizen petition concerning generic versions of DORYX (doxycycline hyclate) Delayed-Release Tablets reaffirms FDA’s policy that in order for two drug product to be in the same “dosage form,” …
- Attention Orange Book Junkies: FDA Petition Response Cements Orange Book Preface Therapeutic Equivalence ClarificationApril 23rd, 2009
By Kurt R. Karst – FDA’s April 2009 response to a September 2007 suitability petition requesting permission to submit an ANDA for a lyophilized generic version of ZOMETA (zoledronic acid) Injection and an FDA determination that such drug product, if approved, would be therapeutically equivalent …
- FDA Resolves Pre-MMA/Post-MMA 180-Day Exclusivity Ambiguity; Determines that Pre-MMA 180-Day Exclusivity Regime Will Apply in “MMA Straddle” CasesApril 16th, 2009
By Kurt R. Karst – FDA’s April 15th decision to approve ANDAs for generic versions of Topiramate Sprinkle Capsules signals a new FDA interpretation of the 180-day generic drug exclusivity provisions of the FDC Act, which were amended in December 2003 under Title XI of …
- Lawsuit Against FDA over VYVANSE NCE Exclusivity Put on Ice While FDA Solicits Public CommentApril 14th, 2009
By Kurt R. Karst – We recently reported on a complaint filed in the U.S. District Court for the District of Columbia by Actavis Elizabeth LLC (“Actavis”) against FDA in which Actavis requested the court to enter an injunction directing FDA to rescind the Agency’s …