By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
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Hatch-Waxman
- Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!June 25th, 2013
- Supreme Court Rules in Bartlett Generic Drug Preemption Case; Says State-Law Design-Defect Claims That Turn on a Drug Warning’s Adequacy are PreemptedJune 24th, 2013
By Kurt R. Karst – Shortly after 10:00 AM this morning, the generic drug industry let out a collective sigh of relief. It was at that time the U.S. Supreme Court issued its highly anticipated ruling in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-0142). …
- Supreme Court Rules in ANDROGEL Patent Settlement Agreement Case; Holds that Agreements are Subject to Antitrust Scrutiny, But Not Presumptively UnlawfulJune 17th, 2013
By Kurt R. Karst – On June 17th, the U.S. Supreme Court issued its much-anticipated opinion in Federal Trade Commission v. Actavis, Inc., 570 U.S. ___ (2013) (Docket No. 12-416) concerning drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”). In a 5-3 …
- House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action DeadlinesJune 13th, 2013
By Kurt R. Karst – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
- Obama Administration Gives Up Fight Over PLAN B After Second Circuit Issues Split Decision on Motion for Stay Pending AppealJune 11th, 2013
By Kurt R. Karst – In a surprising turn of events, the Department of Justice (“DOJ”) sent a letter to Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York indicating that FDA and HHS have complied with his …
- Momenta Spars with Amphastar; Says Federal Circuit’s LOVENOX Safe Harbor Decision Must be Taken Up by the Supreme CourtJune 5th, 2013
By Kurt R. Karst – Earlier this week, Momenta Pharmaceuticals, Inc. and Sandoz Inc. (“Petitioners”) filed their reply to the brief filed late last month by Amphastar Pharmaceuticals, Inc. (“Amphastar”) opposing Petitioners’ petition the U.S. Supreme Court to review the August 3, 2012 judgment of …
- ACI’s Legal and Regulatory Summit on Generic Drugs – the Must-Attend Conference of the Summer!June 5th, 2013
For years now, the American Conference Institute (“ACI”) has put on a series of excellent FDA-related conferences. Those of us in the Hatch-Waxman world look forward to attending the popular annual Paragraph IV Disputes, Maximizing Pharmaceutical Patent Life Cycles, and Hatch-Waxman Boot Camp conferences. They …
- A Fumble Return, Not a Punt Return, in the First FDA Resolution of a 180-Day Exclusivity Punt CaseJune 4th, 2013
By Kurt R. Karst – Fumble!! For years now we have discussed and tracked various FDA decisions (or non-decisions as the case may be) on what have been referred to as “180-day exclusivity punts.” These are instances in which a first applicant eligible for 180-day …
- Bayer Joins the Combo Drug NCE Challenge Club; Petitions FDA for 5-Year Exclusivity for NATAZIAMay 29th, 2013
By Kurt R. Karst – For the third time this year, FDA has been asked to recognize 5-year New Chemical Entity (“NCE”) exclusivity for a fixed-dose combination drug product containing both a never-before-approved active moiety and a previously approved active moiety. In a Citizen Petition …
- FDA is Asked to Deviate From ANDA “Exception Excipient” Policy for Generic VFEND Injection; Precedent Indicates Agency Will Remain FirmMay 21st, 2013
By Kurt R. Karst – A Citizen Petition (Docket No. FDA-2013-P-0203) submitted to FDA earlier this year raises an issue that comes up from time to time – although not typically in a public forum – about the Agency’s so-called “exception excipient” regulations applicable to sponsors …
- While We’re Waiting on Bartlett, Some New Preemption Challenges to ConsiderMay 20th, 2013
By Kurt R. Karst – As folks in the generic drug industry patiently await the U.S. Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-142), a design defect generic drug preemption case (see our previous post here), we thought we would whet …
- FDA Determines Original OPANA ER Not Discontinued for Safety Reasons; Decision Affirms Case-by-Case ReviewMay 13th, 2013
By Kurt R. Karst – Late last Friday, FDA announced that the Agency denied an August 13, 2012 Citizen Petition (Docket No. FDA-2012-P-0895) submitted by Endo Pharmaceuticals Inc. (“Endo”) requesting that the Agency determine that OPANA ER (oxymorphone HCl) Extended-release Tablets approved under NDA No. 021610 …
- Generic and Innovator Drugs: The Next GenerationMay 7th, 2013
By Kurt R. Karst – Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Doctor Who, Star Wars, and, of course, Star Trek. I remember well the voyages of the starship Enterprise under the …
- FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing DebateMay 5th, 2013
By Kurt R. Karst – By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013 Judgment from Judge Edward R. Korman of the U.S. District Court for the Eastern District …
- False Friends: FDA’s “Gift” on NESINA – Present or Poison? It May Depend on Which Hatch-Waxman Language is SpokenMay 3rd, 2013
By Kurt R. Karst – Frau Rommelfanger’s seventh grade German class: that’s where we first learned to appreciate “false friends,” which are pairs of words or phrases in two languages that look or sound alike, but differ significantly in meaning. Never write the word “gift” …