By Kurt R. Karst – Those of us who work in the drug approval world know that a high degree of coordination among various FDA components is necessary for a smooth and efficient approval process. This is particularly true for ANDA generic drug …
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Hyman Phelps McNamara
- What’s the Hang-up? Apotex Sues FDA Over Compliance Failure That’s Stalling ANDA ApprovalsOctober 4th, 2012
- HHS OIG Reports Take Aim At Weight Loss and Immune Support Dietary SupplementsOctober 3rd, 2012
By Ricardo Carvajal & Wes Siegner – The Department of Health and Human Services Office of Inspector General released two reports (see here and here) critical of dietary supplements in the weight loss and immune support categories. OIG focused on those categories because they were reported …
- FDA Sued Over Generic DIOVAN 180-Day Exclusivity; Lawsuit Takes Issue With FDA Forfeiture Decision and “Trust Me” Approach to Exclusivity DecisionsOctober 3rd, 2012
By Kurt R. Karst – The question was not whether, but when, FDA would be sued over a decision involving 180-day generic drug exclusivity and the so-called “failure to obtain timely tentative approval” forfeiture provision at FDC Act § 505(j)(5)(D)(i)(IV). That day has finally come. …
- New Legislation Would Provide Exclusivity Add-on for Significant Drug CombinationsOctober 2nd, 2012
By Kurt R. Karst – Legislation co-sponsored by Representatives Brian Bilbray (R-CA), Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT), and supported by the Melanoma Research Foundation, seeks to encourge the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing …
- GAO Report on Potential Information Security Risks for Certain DevicesOctober 1st, 2012
By Jennifer D. Newberger – The Government Accountability Office (“GAO”) recently issued a report titled, “Medical Devices: FDA Should Expand Its Consideration of Information Security for Certain Types of Devices.” The report was intended to examine how FDA protects active implantable devices against information security risks that …
- FDA’s Voluntary ISO Audit Submission ProgramSeptember 30th, 2012
By Jeffrey K. Shapiro & Jessica A. Ritsick – ISO 13485 (2003) is an internationally recognized management system for the design and manufacture of medical devices. Most device manufacturers have quality systems intended to comply with ISO 13485. FDA has finally implemented a 2007 statutory …
- White House Releases Major Paper on Propelling Innovation in Drug Development and Recognizes HP&M’s Frank Sasinowski for ContributionsSeptember 27th, 2012
By Alexander J. Varond – On September 25, 2012, the President’s Council of Advisors on Science and Technology (“PCAST”) released a report entitled “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.” PCAST is a commission of leading scientists and engineers who …
- Another Orphan Drug Battle; Depomed Sues FDA Over GRALISE Orphan Drug ExclusivitySeptember 27th, 2012
By Kurt R. Karst – Public turmoil over FDA decisions involving orphan drug exclusivity has been relatively rare in recent years. That has changed over the past several months. First there was the lawsuit brough against FDA by K-V Pharmaceutical Company to “restore” …
- In Search Of (ISO) Court in Which to Challenge DEA ISO? The D.C. Circuit May Have an Answer for YouSeptember 26th, 2012
By JP Ellison – Traditionally, challenges to a Drug Enforcement Administration (“DEA”) immediate suspension order (“ISO”) have been litigated, in the first instance, in federal district courts. This is true even when the physician, pharmacy, distributor, wholesaler or other DEA registrant has taken a “belt and …
- Is it a Drug or Device? Court Requires FDA to Explain ItselfSeptember 26th, 2012
By Jennifer M. Thomas & Anne K. Walsh – Yesterday, in a big win for industry, District Court Judge Rosemary Collyer granted French company PREVOR’s Motion for Summary Judgment in a case challenging FDA’s decision to regulate PREVOR’s Diphoterine® Skin Wash (“DSW”) product as a …
- Insight into FDA’s Implementation of FDASIA for DevicesSeptember 25th, 2012
By Jennifer D. Newberger – On Thursday, September 20, the Food and Drug Law Institute (“FDLI”) and the Drug Information Association (“DIA”) co-sponsored a program titled “Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next?” The program discussed many aspects of the recently passed …
- Suit Targeting Benecol Dismissed on Preemption GroundsSeptember 25th, 2012
By Ricardo Carvajal – A federal district court dismissed a class action that took issue with a number of allegedly false and misleading claims made on the label of Benecol, a butter/margarine alternative. The claims at issue include “each serving contains .85g of plant stanol …
- FDA Issues Draft Compliance Guide on Pet Food Intended to Diagnose, Cure, Mitigate, Treat or Prevent Disease, Including ObesitySeptember 21st, 2012
By Riëtte van Laack – Earlier this month, FDA announced the publication of a draft level 1 Compliance Policy Guide (“CPG”) titled “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.” The CPG in clear …
- Legislative Fix Would Allow FDA to Collect GDUFA User FeesSeptember 19th, 2012
By Kurt R. Karst – Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (“GDUFA”) is expected to be introduced this week (and perhaps voted on by both the U.S. House of Representatives and the U.S. Senate). …
- The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not WarrantedSeptember 18th, 2012
By Kurt R. Karst & JP Ellison – The U.S. Solicitor General filed a brief last week urging the U.S. Supreme Court not to grant a Petition for Writ of Certiorari filed earlier this year by a group of ear candle advocates after the U.S. …