• where experts go to learn about FDA
    • GAO Report Blasts FDA for Failure to Implement 2008 RecommendationsOctober 31st, 2010

      By Jennifer B. Davis – Earlier this week, the Government Accountability Office (“GAO”) publicly released its September 2010 Report to the House Committee on Oversight and Government Reform concerning Drug Safety, titled “DRUG SAFETY – FDA Has Conducted More Foreign Inspections and Begun to Improve Its …

    • FDA Announces Meeting on Human MilkOctober 31st, 2010

      By Ricardo Carvajal – FDA announced that its Pediatric Advisory Committee will meet on December 6 to “obtain and discuss information and data that will provide the Agency with a better understanding of current practices, and potential benefits and risks associated with the donation and banking …

    • HP&M’s Frank Sasinowski Added to Biotech Company’s “Wall of Honor”October 29th, 2010

      On Thursday, United Therapeutics Corporation (“UTC”), a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions, unveiled a plaque honoring HP&M Director Frank Sasinowski for his contributions to UTC’s development …

    • REMS and 180-Day Exclusivity Forfeiture – Some Interesting Disclosures to the SECOctober 28th, 2010

      By Kurt R. Karst –       Company submissions to the Securities and Exchange Commission (“SEC”) can be a valuable source of information.  Consider, for example, a recent quarterly report from Celgene Corporation, which states with respect to Risk Evaluation and Mitigation Strategies (“REMS”) that: In the fourth quarter …

    • For Whistleblowers, Complaining to the Government Pays: GlaxoSmithKline Pays $750 Million to Resolve Criminal and Civil Liability for Alleged cGMP FailuresOctober 27th, 2010

      By Peter M. Jaensch & John R. Fleder – A company has “current Good Manufacturing Practice” (“cGMP”) issues.  FDA learns about the issues and engages in dialogue with the company regarding the purported violations.  No big deal and no news story!  Add in a terminated employee who files …

    • Another Capitol Hill Missive Objects to the Inclusion of Patent Settlement Provisions in FY 2011 Appropriations BillOctober 27th, 2010

      By Kurt R. Karst –       Some Senate Democrats have joined their Republican colleagues in voicing opposition to the inclusion of the “Preserve Access to Affordable Generics Act” (S. 369) in the Fiscal Year 2011 Financial Services and General Government Appropriations Bill (S. 3677).  As we previously …

    • Amphastar Challenges FDA Import DetentionOctober 26th, 2010

      By Dara Katcher Levy – How many lawsuits will it take before FDA starts exercising better judgment on imports?  On October 25, 2010, Amphastar Pharmaceuticals Inc. (“Amphastar”) filed suit against FDA seeking declaratory judgment and injunctive relief with regard to FDA’s detention of two entries of …

    • First Circuit Rules for the FTC in Dietary Supplement Advertising CaseOctober 25th, 2010

      By Riëtte van Laack – Direct Marketing Concepts, Inc. (“DMC”) and other companies and individuals marketed Coral Calcium and Supreme Greens by producing and distributing infomercials claiming that these products were an effective cure against many diseases including heart disease, cancer, lupus, etc.  The district court …

    • FDA Grants Petition Requesting a “Superseding” 30-Month Stay for Generic HECTOROLOctober 25th, 2010

      By Kurt R. Karst –       FDA’s recent decision to grant an April 27, 2010 citizen petition submitted on behalf of Genzyme Corporation (“Genzyme”) concerning the Agency’s ability to approve Cobrek Pharmaceuticals, Inc.’s (“Cobrek’s”) pending ANDA for a generic version of HECTOROL (doxercalciferol) Injection sheds some light on …

    • IOM Charts Narrow Course for FOP LabelingOctober 21st, 2010

      By Ricardo Carvajal – The Committee on Examination of Front-of-Package Nutrition Rating Systems and Symbols (part of the Food and Nutrition Board at the Institute of Medicine of the National Academies) recently released a report on the first phase of its study of front-of-package ("FOP") nutrition …

    • CDRH Usability Study – Participants NeededOctober 21st, 2010

      By Jeffrey K. Shapiro – FDA’s Center for Devices and Radiological Health is conducting a usability study of the establishment registration and device listing database. The objective is to make the database easier to use. They are looking for feedback from those who regularly use the …

    • Consumers Bring Action Against Basic ResearchOctober 20th, 2010

      By Susan J. Matthees – Two consumers, a resident of Florida and a resident of New Jersey, have filed a putative class action against Basic Research LLC, Carter-Reed Company, LLC, Dennis Gay, Daniel Mowrey, and Mitchell Friedlander, alleging that Defendants made false and deceptive claims about …

    • Improving Access to Clinical Trials Act Becomes LawOctober 19th, 2010

      By Kurt R. Karst –       Earlier this month, President Obama signed into law S. 1674, the Improving Access to Clinical Trials Act (Pub. L. No. 111-255).  The bill, introduced in the Senate by Senator Ron Wyden (D-OR) in September 2009, amends the Social Security Act (42 …

    • New Draft Guidance for Industry: INDs – Determining Whether Human Research Studies Can Be Conducted Without an INDOctober 18th, 2010

      By Dara Katcher Levy & Diane B. McColl -  Last week, FDA issued a draft guidance intended to assist sponsors and investigators with decisions as to whether human research studies can be conducted on products without an investigational new drug application ("IND").  The draft guidance explains  …

    • TRICARE Reissues Retail Pharmacy Refund Rule Largely UnchangedOctober 18th, 2010

      By Alan M. Kirschenbaum – After conducting a regulatory exercise mandated by court order, the Department of Defense (“DoD”) on Friday issued a regulation that is virtually identical to a regulation issued in March 2009 to implement its TRICARE retail drug refund program.  As we previously …