By Kurt R. Karst – “Driveway moments” – most of us have had them. It’s that moment when we feel compelled to stay in the car and finish listening to something on the radio. This blogger recently had such a moment commuting home from work on …
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- FDA Was For PROCYSBI Orphan Drug Designation Based on Clinical Superiority Before It Was Against It . . . And Then For It AgainAugust 3rd, 2014
- FDA Issues Final Guidance on Evaluating Substantial EquivalenceJuly 31st, 2014
By Allyson B. Mullen — On July 28, 2014, FDA issued the final guidance document “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” The draft of this guidance was issued on December 27, 2011 (see our earlier blog post here). Very little has changed …
- “Pedigree Nouveau” Must Be Uncorked January 1July 30th, 2014
By Douglas B. Farquhar – While Wikipedia tells us that this year’s Beaujolais Nouveau will best be consumed during a flexible time period beginning November 21, drug manufacturers and drug wholesalers should be warned that there is less flexibility in an important deadline for the “pedigree …
- ACI’s 23rd FDA Boot CampJuly 30th, 2014
The American Conference Institute’s popular FDA Boot Camp, now in its 23rd iteration, is slated to take place at the Omni Parker House Boston in Boston, MA from Thursday, September 18 to Friday, September 19, 2014. The conference is billed as the premier event to …
- OIG Issues Favorable Advisory Opinion on Drug Manufacturer’s Direct-To Patient Discounted Drug Sales ProgramJuly 29th, 2014
By Jay W. Cormier & Alan M. Kirschenbaum – In an advisory opinion posted on Monday, July 28, 2014, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) determined that no enforcement action would be taken against a drug manufacturer’s …
- Second Circuit Overturns Win for Nonprofit Groups in Litigation with FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal FeedJuly 29th, 2014
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 …
- 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 …