By Kurt R. Karst – For several years now, the Obama Administration’s annual budget requests (here, here, and here, for example) have included proposals to reduce to 7 years the current 12-year period of Reference Product Exclusivity (“RPE”) for biological products licensed under Section 351(a) of …
By Kurt R. Karst – It’s been a little more than 4.5 years since we first revealed in a December 11, 2011 FDA Law Blog post the fruits of our hunt for the mythical list of pending proceedings under the Drug Efficacy Study Implementation …
By Karla L. Palmer – FDA published last week two final “Interim Policies” for compounding using bulk substances under Sections 503A and 503B of the Federal Food, Drug and Cosmetic Act (here and here). FDA first published draft policies back in October 2015 (see our previous …
By Kurt R. Karst – Earlier this week, Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) announced the introduction of bipartisan legislation that they say is intended to “end inappropriate delay tactics that are used by some brand-name drug manufacturers …
By Kurt R. Karst – It was just last week when one orphan drug exclusivity labeling carve-out case (presumptively) came to an end when the U.S. Court of Appeals for the District of Columbia Circuit ruled for FDA in the context of a generic version of …
By Kurt R. Karst & Douglas B. Farquhar – On June 3, 2016, a three-judge panel (Judges Thomas B. Griffith, Brett M. Kavanaugh, and Robert L. Wilkins) of the U.S. Court of Appeals for the District of Columbia Circuit ruled for FDA and Intervenor-Appellee Sandoz, Inc. …
By Jenifer R. Stach & Alan M. Kirschenbaum – In our blog post last Fall reporting on an a new price increase penalty imposed on generic drugs under the Medicaid Drug Rebate Program, we predicted more drug price legislation to come. The next statutory response to …
By David C. Gibbons & Jeffrey N. Wasserstein – The most recent assault on FDA’s regulation of off-label promotion came from Congress. In a recent letter to the Secretary of the Department of Health and Human Services (HHS), the House Committee on Energy and Commerce told …
By Kurt R. Karst – It’s been just over a year – May 28, 2015 – since Judge Randolph D. Moss of the U.S. District Court for the District of Columbia handed down his 40-page Opinion in a lawsuit lodged by Amarin Pharmaceuticals Ireland Limited (“Amarin”) …
By Kurt R. Karst – A recent letter decision from FDA to the Patent and Trademark Office (“PTO”) concerning the availability of a Patent Term Extension (“PTE”) for U.S. Patent No. RE 41,571 (“the ‘571 patent), a method-of-use patent listed in the Orange Book covering Purdue …
By Kurt R. Karst – The first iteration of the Generic Drug User Fee Amendments (“GDUFA”) – “GDUFA I” – is now well into Year 4 of the 5-year program, and anticipation is growing as to what the second iteration of the program – “GDUFA II” …
By Karla L. Palmer – A Massachusetts United States district court judge decided last week whether the United States’ reliance on alleged violations of the United States Pharmacopeia (“USP”) compendium addressing sterility of compounded preparations was a permissible delegation of legislative power to USP to define …
By James E. Valentine & Josephine M. Torrente – In March, FDA published a draft guidance document that describes FDA’s approach to the implementation of the statutory provision in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an …
By James E. Valentine & Alexander J. Varond – FDA recently issued draft guidance, entitled “Special Protocol Assessment,” which, when finalized, will replace FDA’s 2002 final guidance by the same title. At 23-pages long, the draft guidance is much more thorough than its predecessor (only 11 …
By Kurt R. Karst – Speculating about the prospects that FDA will grant a period of marketing exclusivity – 5-year New Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity, 7-year orphan drug exclusivity, or any other type of exclusivity or add-on exclusivity – upon the …
