By Kurt R. Karst – After more than three years of litigation that started with a July 2010 Complaint filed in the U.S. District Court for the Southern District of New York (see our previous post here), and that went up to the U.S. Court of …
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OTC Drugs and Cosmetics
- FDA Enters Into Consent Decree; Agrees to Timely Complete Triclosan OTC Drug Antiseptic MonographsNovember 28th, 2013
- Sanofi Sues FDA to Prevent Disclosure of OTC NASACORT Labeling Before Product Launch; Claims FOIA Exemption 4November 7th, 2013
By Kurt R. Karst – Earlier this week, sanofi-aventis U.S., LLC (“Sanofi”) filed a Complaint in the U.S. District Court for the District of Columbia against FDA in what appears to be a first-of-its-kind lawsuit. Sanofi alleges that FDA’s decision to make public a copy of …
- As Partial Government Shutdown Kicks In, FDA’s Foods Program Is Hardest HitOctober 1st, 2013
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
- Alameda County Drug Take-Back and Disposal Ordinance Not Unconstitutional Says Federal JudgeSeptember 3rd, 2013
By Kurt R. Karst – Last week, Judge Richard Seeborg of the U.S. District Court for the Northern District of California issued an 11-page ruling in a lawsuit filed in December 2012 by the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and …
- An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing DirectionsAugust 26th, 2013
By Kurt R. Karst – Earlier this year, FDA’s Dallas District Office issued a Warning Letter to Sovereign Pharmaceuticals, LLC (“Sovereign”), a pharmaceutical contract manufacturing facility located in Fort Worth, Texas, containing a rather interesting – and quite perplexing – violation tagged under the heading “Unapproved …
- ACI’s 2nd Annual Over-the-Counter Drugs Forum & Inaugural Paragraph IV Disputes Master SymposiumAugust 4th, 2013
The American Conference Institute (“ACI”) will be holding two events in the coming months that are of particular interest to FDA Law Blog readers. . . . and, importantly, for which our readers can get a discount. The first event is ACI’s Legal, Regulatory, and …
- Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!June 25th, 2013
By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
- House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action DeadlinesJune 13th, 2013
By Kurt R. Karst – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
- FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing DebateMay 5th, 2013
By Kurt R. Karst – By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013 Judgment from Judge Edward R. Korman of the U.S. District Court for the Eastern District …
- Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as “Unprecedented” and “Politically Motivated”April 8th, 2013
By Etan J. Yeshua & Kurt R. Karst – Last Friday, a federal district court judge, in a 59-page decision, ordered FDA to make the emergency contraceptive PLAN B (levonorgestrel) available Over-the-Counter (“OTC”) and without age restrictions. In doing so, Judge Edward R. Korman of …
- Second Circuit Comes to a Split Decision on Standing in NRDC Lawsuit Over OTC Triclosan and Triclocarban ProductsMarch 19th, 2013
By Kurt R. Karst – Earlier this week, the U.S. Court of Appeals for the Second Circuit issued a decision that paves the way for the Natural Resources Defense Council (“NRDC”) to pursue its action to compel FDA to finalize the Agency’s review and regulation …
- U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House BillMay 25th, 2012
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
- On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for DebateFebruary 29th, 2012
By Kurt R. Karst – Every few years, interest in the creation of a third category of drug products – something other than prescription or Over-the-Counter (“OTC”) status – is piqued by FDA, Congress, or by some other entity. The most recent attempt to explore the …
- FDA Sued For Not Acting on Nanotech Citizen PetitionDecember 29th, 2011
By Ricardo Carvajal – Several nonprofit groups sued FDA for its failure to respond to a May 2006 citizen petition asking that products of nanotechnology be subject to specific regulatory requirements, and that FDA stop the marketing of sunscreens that contain nanoparticles. The complaint alleges that …
- NAD Says Fast Relief Claims for Crest Sensitivity Toothpaste Should Be DiscontinuedDecember 15th, 2011
By Susan J. Matthees – The National Advertising Division (“NAD”) of the Council of Better Business Bureaus recently concluded that claims that Procter & Gamble’s Crest Sensitivity Treatment & Protection Toothpaste could provide relief from sensitive teeth “within minutes” should be discontinued. Colgate-Palmolive brought the challenge …