By Kurt R. Karst – In a 2-1 decision handed down last week, a panel of judges from the U.S. Court of Appeals for the Second Circuit reversed both a March 2012 decision and a June 2012 decision from the U.S. District Court for the Southern …
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Year: 2014
- Second Circuit Overturns Win for Nonprofit Groups in Litigation with FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal FeedJuly 29th, 2014
- FDA Rejects Requests to Initiate Rulemaking for 505(b)(2) NDA Therapeutic Equivalence Rating DecisionsJuly 28th, 2014
By Kurt R. Karst – In a rather lengthy (33-page) response to two citizen petitions submitted to FDA by AbbVie Inc. (Docket No. FDA-2011-P-0610) and Auxilium Pharmaceuticals, Inc. (Docket No. FDA-2013-P-0371) concerning their testosterone gel 1% drug products – AbbVie’s ANDROGEL (NDA No. 021015) and Auxilium’s TESTIM …
- Consumer Groups File Motion to Intervene in Vermont GE Labeling LitigationJuly 25th, 2014
By Ricardo Carvajal & JP Ellison – The Vermont Public Interest Research Group ("VPIRG") and Center for Food Safety ("CFS") filed a motion to intervene in the lawsuit challenging Vermont’s new law requiring labeling for foods produced with genetic engineering (see our prior posting here). VPIRG …
- Court Finds Three Appointments Tainted the FDA’s Tobacco Products Scientific Advisory Committee, Including its Menthol ReportJuly 23rd, 2014
By Jay W. Cormier & David B. Clissold — Although an apple a day idiomatically keeps the doctor away, it appears true to one federal judge that one bad apple (or in this case three) really does spoil the bunch. As we previously reported here, in 2011, Lorillard, Inc., …
- New Developments in the Ongoing PhRMA v. HHS/HRSA Saga Over the Interpretation of the Exclusion of Orphan Drugs Under the 340B ProgramJuly 23rd, 2014
By Michelle L. Butler – On July 21, 2014, the Department of Health and Human Services (“HHS”)/Health Resources and Services Administration (“HRSA”) announced the availability of an interpretive rule titled “Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program,” which …
- FDA Releases Report on Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare DiseasesJuly 21st, 2014
By Alexander J. Varond — FDA recently released its report entitled “Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases Including Strategic Plan: Accelerating the Development of Therapies for Pediatric Rare Diseases.” The report fulfills the …
- FDA’s Intervening NDA Approval Policy Strikes Again; Agency Denies Antares Petition on MethotrexateJuly 20th, 2014
By Kurt R. Karst — Beginning in 1999, around the time FDA issued a (still) draft guidance document on 505(b)(2) applications, and lasting until about 2009, this blogger taught an introduction to drug law course at FDA to FDAers. The focus of my talk was – surprise, surprise …
- FDA Refreshes 16-Year Old Informed Consent Guidance, Addresses Considerations for Vulnerable PopulationsJuly 17th, 2014
By James E. Valentine* — On July 15, 2014, FDA announced the availability of a draft guidance, titled “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors” (“FDA Draft Information Sheet”). When final, it will replace the Agency’s informed consent 1998 Information Sheet, “A Guide …
- Yet Another Petition to FDA Says: “Gimme My 5-Year NCE Exclusivity!” But What’s it to Ya?July 16th, 2014
By Kurt R. Karst – Our FDA Citizen Petition Tracker is littered with petitions and petitions for reconsideration submitted to FDA over the past 18 months requesting that the Agency recognize a period of 5-year New Chemical Entity (“NCE”) exclusivity for certain Fixed-Dose Combination Drugs (“FDCs”) …
- Want to Unlock the 21st Century Cure? Hearing Witnesses Agree, Patient Input is KeyJuly 16th, 2014
By James E. Valentine* & Sara A. Khan** – On July 11, 2014, the House Energy and Commerce’s Subcommittee on Health held its fourth hearing, as part of its 21st Century Cures Initiative, to seek input regarding the incorporation of patient perspectives in drug development and …
- After a Draw in Court, Zogenix and Massachusetts Battle Over ZOHYDRO ER May Have to Proceed to a Penalty Shootout RoundJuly 14th, 2014
By Kurt R. Karst – We watched the World Cup final between Germany and Argentina this past weekend and were pleased with the outcome (well, at least this blogger was). Things got pretty intense as the minutes in extra time ticked away, edging the match ever …
- FDA Releases Updated Total Diet Study Results (and Advises Consumers to Keep Eating)July 13th, 2014
By Ricardo Carvajal – FDA released data for its Total Diet Study (TDS) covering the period from 2006 to 2011. Under the TDS, FDA collects data on levels of pesticide residues, industrial chemicals, toxins, and nutrients present in foods to monitor changes in the levels of …
- The 2014 ABA Blawg 100 – Our Best Arnold Horshack Plea for NominationsJuly 11th, 2014
It’s July, and that means the American Bar Association (“ABA”) has initiated the annual process for selecting the top legal blogs (or “blawgs”) in the blogosphere. The 8th iteration of the list will be revelaed later this year when the ABA announces the “Blawg 100” …
- FDA Issues GDUFA ANDA Amendment and PAS Guidances Explaining Implementation of Some of the More Complex Provisions of the User Fee AgreementJuly 10th, 2014
By Kurt R. Karst – Earlier this week, and just a day after the second anniversary of the 2012 FDA Safety and Innovation Act that, among other things, includes the Generic Drug User Fee Amendments (“GDUFA” ), FDA announced the release of two draft guidance documents …
- With Briefing Nearly Complete, Folks Get Set to Hunker Down for High-Stakes Rulings in Challenges to BPCIA Biosimilars “Patent Dance” ProceduresJuly 10th, 2014
By Kurt R. Karst – Earlier this year we posted on two pending lawsuits brought by potential biosimilar applicants challenging the the so-called “patent dance” patent resolution provisions added to the PHS Act by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). The BPCIA …