Prescription Drugs and Biologics

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 …

By William T. Koustas & Jessica A. Ritsick – In light of California’s looming electronic pedigree requirement, still scheduled to become effective in 2015, we have been following Congress’s progress toward a national prescription drug track and trace system (see our previous post here).  The …

By Joseph W. Cormier – FDA recently issued a draft guidance, titled “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (“the Draft Guidance”), detailing its thoughts regarding appropriate quality agreements between product “owners”, which FDA defines as persons who introduce or cause the introduction of a …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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” …

By Kurt R. Karst –       Bayer HealthCare, LLC’s (“Bayer’s”) court challenge to FDA’s approval of Abbreviated New Animal Drug Application (“ANADA”) No. 200-495 submitted by Norbrook Laboratories, Ltd. (“Norbrook”) for Enroflox™ 100, a generic version of Bayer’s fluroquinolone animal drug Baytril® 100 (enrofloxacin) Injectable Solution, …

By Karla L. Palmer – The Senate’s Health, Education, Labor and Pensions (“HELP”) Committee released draft legislation on Friday, April 26, 2013, that would replace section 503A of the Federal Food, Drug & Cosmetic Act (“FDCA”), amend other sections, and clarify FDA’s authority to regulate …