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 …
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Prescription Drugs and Biologics
- A New and Improved (Updated) List of Pending DESI Program ProceedingsJune 21st, 2016
- FDA Publishes Final “Interim Policy” for Both Sections 503A and 503B Compounding from Bulk Substances: Section 503B BulksJune 20th, 2016
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 …
- The CREATES Act Would Create a Cause of Action to Obtain Restricted Product Sample and to Facilitate Shared REMSJune 17th, 2016
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 …
- Just When FDA Thought It Was Out, They Pull It Back In: AstraZeneca Raises 505A(o) and Orphan Drug Exclusivity Carve-Outs in CRESTOR PetitionJune 8th, 2016
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 …
- FDA, Sandoz Prevail at D.C. Circuit on Generic FUSILEV ApprovalJune 6th, 2016
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. …
- Vermont Responds to Drug Price Increases With Transparency LawJune 6th, 2016
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 …
- First the Courts, Now Congress… House Committee Throws its Weight Behind Evolving Legal Landscape of Off-Label PromotionJune 1st, 2016
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 …
- It’s Finally Here! FDA’s VASCEPA Exclusivity Determination on Remand: NCE Exclusivity Granted!May 31st, 2016
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”) …
- FDA Rejects “Extraordinary” Position in Battle Over BUTRANS Patent Term ExtensionMay 23rd, 2016
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 …
- RLD Designation Citizen Petitions: One Item on Our GDUFA II Wish ListMay 18th, 2016
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” …
- Congress’ Dubious Delegation of Legislative Authority to USP Standards Results in “Instructions”– But Not “Dismissal” – Related to the NECC Criminal IndictmentMay 12th, 2016
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 …
- HP&M Seeks Alternative Statutory Reading of BPCI Act “Deemed to be a License” ProvisionMay 9th, 2016
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 …
- FDA Revises Guidance on Special Protocol Assessments, Attempts to Reduce UncertaintyMay 9th, 2016
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 …
- Speculating About the Prospects of Exclusivity – A Potentially Risky GameMay 5th, 2016
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 …
- The COMBAT Act Would Add New Brand and Generic Exclusivity-Stacking Incentives for Abuse-Deterrent Opioid DevelopmentMay 2nd, 2016
By Kurt R. Karst – On April 29, 2016, Represetatives Gerry Connolly (D-VA) and Morgan Griffith (R-VA) announced the introduction of H.R. 5127, the “Curb Opioid Misuse by Advancing Technology (COMBAT) Act.” The COMBAT Act is the latest effort by Congress to incentivize the development of …