• where experts go to learn about FDA
    • Here We Go Again . . . . Amphastar Renews Generic LOVENOX Case Against FDADecember 30th, 2010

      By Kurt R. Karst –       Amphastar Pharmaceuticals Inc. (“Amphastar”) has filed with the U.S. District Court for the District of Columbia an Amended Complaint for Declaratory and Injunctive Relief against FDA in Amphastar’s continuing battle to win approval of the company’s long-pending Abbreviated New Drug Application …

    • Must FDA Treat Similarly-Situated Competitors the Same Way?December 29th, 2010

      In his latest article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Director John R. Fleder explores whether the FDA should enforce the FDC Act by giving different treatment to similarly-situated competitors.  The article reaches the conclusion that the public is not well served …

    • U.S. Supreme Court Petitioned to Review Federal Circuit Patent Use Code DecisionDecember 28th, 2010

      By Kurt R. Karst –       Another week, another Petition for Writ of Certiorari filed with the U.S. Supreme Court on an issue involving the drug industry.  The latest petition comes from Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”) and Sun Pharmaceutical Laboratories, Ltd. (“Sun”) and requests the Court’s …

    • With the Food Safety Modernization Act Set to Become Law, Certain Provisions Will Take Immediate EffectDecember 23rd, 2010

      By Ricardo Carvajal -  Although many of the Food Safety Modernization Act's ("FSMA's") major provisions have a delayed effective date (including the requirement to develop and implement a HACCP plan), some significant provisions will take immediate effect, including:   Stronger records access authority (FSMA § 101).  FDA gains authority …

    • DEA to Hold Public Meeting on Controlled Substances Disposal RegulationsDecember 23rd, 2010

      By John A. Gilbert & Karla L. Palmer -  The Drug Enforcement Administration announced earlier this week that it is holding a public meeting to discuss with interested persons procedures for the surrender of unwanted controlled substances by ultimate users and long term care facilities.  The …

    • Will Bessie, Porky, Fido, Puss and Poly Get Their Meds?December 23rd, 2010

      By Wes Siegner – On December 20, 2010 FDA published a notice requesting comments on how the agency can address a “problem” that has existed since the 1960s, when the Federal Food, Drug, and Cosmetic Act ("FDC Act") was amended in to require premarket approval.  The problem …

    • Court Rules that a Dietary Supplement Company Needed Clinical Trials with Human Subjects to Support Advertising ClaimsDecember 22nd, 2010

      By Riëtte van Laack – In a short, unpublished decision issued on December 10, 2010, the D.C. Circuit denied a petition filed by Daniel Chapter One and James Fejio (“DCO”) seeking review of an FTC cease and desist order.  The FTC Order, issued in 2009, concluded …

    • House Passes Food Safety LegislationDecember 21st, 2010

      As expected, the U.S. House of Representatives passed the Food Safety Modernization Act (H.R. 2751) as passed by the Senate.  The bill now goes to the President, who is expected to sign it into law.  A copy of the bill is available here (scroll down to …

    • Sandoz Requests 180-Day Exclusivity Forfeiture Decision for Generic HECTOROLDecember 21st, 2010

      By Kurt R. Karst – In a recent citizen petition submitted to FDA, Sandoz Inc. (“Sandoz”) requests from the Agency a written decision that Cobrek Pharmaceuticals, Inc. (“Cobrek”), the alleged “first applicant” for a generic version of HECTOROL (doxercalciferol) Injection, has forfeited 180-day exclusivity eligibility.  The …

    • Notorious Affiliate Exclusion Provision of PPACA RepealedDecember 21st, 2010

      By Alan M. Kirschenbaum – Exclusion from Medicare and Medicaid is a potent weapon used by the government against program-related fraud, but it can be a double edged sword when wielded against drug and medical device companies.  Exclusion of a drug or device company means that …

    • Twitter Delayed is Twitter Denied: DDMAC Social Media Guidance Delayed until 2011December 21st, 2010

      By Jeffrey N. Wasserstein – As our loyal blog readers know, we are great fans of social media, and follow these topics in earnest (here, here, and here).  We have just learned that the long-awaited FDA guidance that was promised to come out by year-end will …

    • Are Attorneys the FDA’s New Enforcement Target?December 20th, 2010

      By Jamie K. Wolszon –   Hyman, Phelps & McNamara, P.C. Directors Douglas B. Farquhar and John R. Fleder presented a webinar on Monday December 20, 2010 for Thompson Interactive entitled: “Are Attorneys the FDA’s New Enforcement Target?”  The webinar slides can be found here.  The …

    • Court Upholds Exclusion of Former Purdue ExecutivesDecember 20th, 2010

      By JP Ellison – In Dickens’ A Christmas Carol, the main character is visited by three ghosts who by scaring him with visions of his past, present and future, seek to change him.  On December 13, 2010, in the form of a U.S. District Court for …

    • Surprise, Surprise. . . Food Safety Legislation Roars Back to LifeDecember 20th, 2010

      By Ricardo Carvajal – Capping a week-long flurry of legislative activity, the Senate reportedly passed the Food Safety Modernization Act by a voice vote Sunday night.  The legislation now returns to the House, where approval is likely.  Given that the President’s signature is certain, it now appears …

    • FDA Steps Up Efforts Against “Tainted” Products Masquerading as Dietary SupplementsDecember 19th, 2010

      By Riëtte van Laack – On December 15, 2010, FDA took several steps to increase its enforcement against products that are marketed as dietary supplements but contain analogs of, or the same active ingredients as, FDA-approved drugs, or other substances that do not qualify as dietary …