By Kurt R. Karst – The voice of Michael Corleone – “Just when I thought I was out . . . they pull me back in” – played over and over again in our heads today when we learned that Apotex, Inc. filed a Petition for …
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Hyman Phelps McNamara
- It Lives!! Apotex Asks the Supreme Court to Review Generic COZAAR/HYZAAR 180-Day Exclusivity Decision (Our 1,000th Post)October 5th, 2010
- WSJ Stakes Out Position on Patent Settlements; Takes Issue with the FTC’s “Evangelical Zeal”October 5th, 2010
By Kurt R. Karst – In a short, but scathing opinion piece published in the October 5th Wall Street Journal (“WSJ”), the editors take on the Federal Trade Commission (“FTC”) and those Members of Congress who want to ban patent settlements between brand-name and generic drug …
- HP&M Attorney to Speak at CBI Paragraph IV Disputes ConferenceOctober 5th, 2010
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be speaking at the Center for Business Intelligence’s (“CBI’s”) 3rd Annual Life Sciences Congress on Paragraph IV Disputes, which is scheduled for October 18-19, 20109 at the Hilton Alexandria Old Town in Alexandria, Virginia. This popular …
- Of Fish, Milk, and Beets: Biotech Heats Up (Again)October 4th, 2010
By Ricardo Carvajal – No sooner did FDA hold its advisory committee meeting and public hearing on bioengineered AquAdvantage salmon than Congressional representatives made their displeasure known with the prospect of FDA approval. In addition to signing on to letters of protest to the Commissioner (here …
- HP&M Presents the Evolution of FDA and the Park Doctrine for Criminal Prosecutions of Corporate ExecutivesOctober 4th, 2010
Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic. You can register for the free webinar here. The webinar will feature attorneys with decades of experience in FDA’s application of …
- Secure and Responsible Drug Disposal Act Passes CongressOctober 3rd, 2010
By John A. Gilbert & William T. Koustas – The United States Congress passed the Secure and Responsible Drug Disposal Act of 2010 (“the Act”) on September 29, 2010, and it is soon expected to be signed into law by the President. This Act is intended …
- FDA Releases Draft Guidance on Acidified FoodSeptember 30th, 2010
By Ricardo Carvajal – FDA announced the availability of a draft guidance on acidified food intended to help processors determine whether their products are subject to the current good manufacturing practice ("CGMP") requirements in 21 CFR part 114 and the “Specific Requirements and Conditions for Exemption …
- OIG Enforcement Initiative Regarding AMP and ASP ReportingSeptember 29th, 2010
By Michelle L. Butler – Yesterday, the Office of the Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued a Special Advisory Bulletin regarding a new enforcement initiative to promote increased compliance by manufacturers with regard to reporting of average manufacturer prices …
- FTC Complaint Charges POM Wonderful LLC’s Advertising Not Supported by Competent and Reliable EvidenceSeptember 29th, 2010
By Riëtte van Laack – On September 27, 2010, less than two week after POM Wonderful LLC (“POM”) filed a complaint against the Federal Trade Commission (“FTC”) (see our previous post here), the Agency filed a Complaint against POM, its sister corporation Roll International Corp. and …
- HPM Attorneys to Present at FDLI’s Enforcement and Litigation ConferenceSeptember 29th, 2010
Hyman, Phelps & McNamara, P.C.’s Douglas Farquhar and Ricardo Carvajal will be presenting at FDLI’s upcoming two-day conference on FDA enforcement and litigation. Mr. Farquhar will moderate a panel on elements of proof in an injunction case, and will present on misdemeanors, debarment, and exclusion. …
- California’s Green Chemistry Regulations; A Lot of R&R (Requirements and Responsibilities) for Regulated IndustrySeptember 28th, 2010
By Randy Pollack*, Wes Siegner & Brian J. Donato – In September 2008, California Governor Arnold Schwarzenegger signed landmark green chemistry legislation authorizing the Department of Toxic Substance Control (“DTSC”) to: (1) identify and prioritize chemicals of concern, evaluate alternatives as well as to specify regulatory …
- Reform of The De Novo Classification Process Needs To Be A Top PrioritySeptember 27th, 2010
By Jeffrey K. Shapiro – The de novo classification procedure was added to the FD&C Act in 1997 to create a middle pathway between the 510(k) process and full blown premarket application ("PMA") approval. It is intended for devices that utilize novel technologies that are not …
- Flare-Up Over Generic Herpes Drug Could be Short-LivedSeptember 27th, 2010
By Kurt R. Karst – Just two days after Novartis Pharmaceuticals Corporation (“Novartis”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s September 14th approval of Watson Laboratories, Inc.’s ANDA No. 78-278 for a generic version of the herpes …
- Novartis Sues FDA Over Generic FAMVIR; Alleges that FDA Failed to Require a Split CertificationSeptember 23rd, 2010
By Kurt R. Karst – On September 22, 2010, Novartis Pharmaceuticals Corporation (“Novartis”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s September 14th approval of Watson Laboratories, Inc.’s ANDA No. 78-278 for a generic version of the herpes …
- HRSA Initiates Rulemaking to Implement Health Reform Changes to the 340B Drug Pricing ProgramSeptember 22nd, 2010
By Jennifer B. Davis – On September 20, 2010, the Health Resources and Services Administration (“HRSA”) issued two Advanced Notices of Proposed Rulemaking and Requests for Comment (here and here) announcing its preliminary plans, and requesting stakeholder input, on how best to implement new authorities over …