By Kurt R. Karst – Last month we posted on a bill introduced in the U.S. Senate – S. 2041, the Promoting Life-Saving New Therapies for Neonates Act of 2015 – that would amend the FDC Act to add Section 530 to create a transferable “Neonatal …
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Prescription Drugs and Biologics
- Congress Continues Spree of Proposing Alternative Incentives for Product Development: the “CBRN Countermeasure PRV” (Part 1)October 22nd, 2015
- You Win Some, You Lose Some: Federal Circuit Denies En Banc Review in BPCIA Dispute & Otsuka Files Suit Over 3-Year ExclusivityOctober 19th, 2015
By Kurt R. Karst – Predicting the future is a tricky business. Predictions don’t often pan out, even when most or all of the indicators prognosticators use say something will (or will not) happen. We have a pretty decent track record of guessing how a case …
- A Long Overdue Revision to the Intended Use RegulationOctober 18th, 2015
By Jeffrey K. Shapiro – A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. The intended use of …
- CTTI Releases Recommendations and Tools to Maximize Engagement between Research Sponsors and Patient GroupsOctober 7th, 2015
By James E. Valentine* – In recent years there has been an increasing focus on patient engagement, centering on new opportunities for FDA to incorporate the patient perspective into its regulatory decision making. These discussions have resulted in Congress and FDA establishing new policies and programs …
- FDA Rules on the Scope of ABILIFY 3-Year Exclusivity and Approves ARISTADA With NCE ExclusivityOctober 7th, 2015
By Kurt R. Karst – Hatch-Waxman controversies are often like trains barreling down railroad tracks. They first appear in the distance as small objects, seemingly moving at a slow velocity. But with each passing moment, the object grows larger and more distinct, and appears to pick …
- The NPRM for the Common Rule: 88 Questions to Answer in 90 DaysOctober 4th, 2015
By James E. Valentine* & David C. Clissold – On September 8, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies announced a Notice of Proposed Rulemaking (NPRM) to revise the Federal Policy for the Protection of Human Subjects, …
- No False Starts: FDA Prevails in Eisai Challenge Over NCE Exclusivity Start Dates for BELVIQ and FYCOMPAOctober 1st, 2015
By Kurt R. Karst – On September 30, 2015, Judge Randolph D. Moss of the U.S. District Court for the District of Columbia issued his highly-anticipated decision in a lawsuit lodged by Eisai Inc. (“Eisai”) last August challenging FDA's April 2014 denial of a Citizen Petition (Docket No. FDA-2013-P-0884) requesting that the Agency conclude that the …
- FDA’s Seventh Annual Report to Congress on 505(q) Citizen Petitions: A Lot of the Same Old Same OldSeptember 29th, 2015
By Kurt R. Karst – FDA recently released the Agency’s Seventh Annual Report to Congress, required by FDC Act § 505(q)(3), on FDA’s experience during Fiscal Year 2014 (“FY 2014”) with citizen petitions subject to FDC Act § 505(q). Other than some updated numbers fo FY …
- How Effective is a “Depomed Threat” at Resolving an Orphan Drug Clinical Superiority Dispute?September 27th, 2015
By Kurt R. Karst – The legal world is chock-full of tests, doctrines, and processes named after a particular case or court decision. It’s kind of a legal short-hand; a lexicon of legal eponyms. There’s the “Winter Standard” for preliminary injunctions in federal courts; the “Lemon …
- Amgen Wants Patent Dance Redo and a Halt to Hospira’s EPOGEN BiosimilarSeptember 24th, 2015
By Kurt R. Karst – One day in the future, reporting on biosimilar patent dance challenges lodged pursuant to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) will be considered passé. Such challenges will be as commonplace as Hatch-Waxman Paragraph IV challenges. Indeed, earlier …
- The Promoting Life-Saving New Therapies for Neonates Act of 2015: A New Twist on Transferable VouchersSeptember 20th, 2015
By Kurt R. Karst – Finding new ways to incentivize and reward drug development for particular therapeutic needs is all the rage these days. Over the past few years we’ve seen several new incentives incorporated (and proposed for incorporation) into the FDC Act. These new incentives …
- Latest FDLI Update Magazine Features Analysis of Amarin Case Written by HP&M AttorneysSeptember 17th, 2015
The latest issue of the Food and Drug Law Institute’s “Update” magazine features an analysis of the recent case of Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. May 7, 2015), written by Hyman, Phelps & McNamara, P.C. attorneys David C. Gibbons and Jeffrey N. …
- Another First Amendment Challenge to FDA’s Restrictions on Promotion; Pacira’s Postsurgical Analgesia Drug Could Mean More Pain for FDASeptember 16th, 2015
By David C. Gibbons & Anne K. Walsh – In the wake of what industry is touting as Amarin’s First Amendment victory (read our Amarin posts here and here), Pacira Pharmaceuticals, Inc. (“Pacira” or the “Company”) filed a suit raising similar claims in the same district …
- FDA Gives a “Nudge Nudge Wink Wink” in Denial of NORD Petition on Special Treatment of Orphan DrugsSeptember 16th, 2015
By Kurt R. Karst – In a September 10, 2015 Response to a September 2, 2011 Citizen Petition (Docket No. FDA-2011-P-0657) submitted by the National Organization for Rare Disorders (“NORD”), FDA refuses to add a statement to guidance documents concerning orphan drugs that the Agency’s official …
- Lather, Rinse, Repeat: Senators Take Another Stab at Passing the Preserve Access to Affordable Generics ActSeptember 14th, 2015
By Kurt R. Karst – Last week, Senators Amy Klobuchar (D-MN) and Charles Grassley (R-IA) announced the introduction of S. 2019, the Preserve Access to Affordable Generics Act. The bill is the latest attempt to pass legislation to address pharmaceutical patent settlement agreements (aka “reverse payment …