By Ricardo Carvajal & John R. Fleder – On November 26th, Commissioner Hamburg issued an order suspending the registration of the Sunland Inc. food manufacturing facility alleged to be at the heart of the ongoing recall of peanut products potentially contaminated with Salmonella. Until the order …
By Kurt R. Karst – FDA’s opening brief in the Agency’s appeal of a March 27, 2012 Memorandum Opinion and accompanying Order issued by Judge Richard J. Leon of the U.S. District Court for the District of Columbia (as modified by a June 22, 2012 …
By Karla L. Palmer – The Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations issued a Majority Memorandum announcing that it is holding a hearing titled “The Fungal Meningitis Outbreak: Could It Have Been Prevented?” The hearing will begin at 10:00 am at Room …
By Kurt R. Karst & Jeffrey N. Gibbs – We’ve been following litigation involving the Florida veterinary compounding pharmacy Franck’s Lab, Inc. (“Franck’s”) for a couple of years. We won’t get into all of the case details here – for that, see our previous posts …
By Kurt R. Karst – It was 50 years ago today (October 10th) that President John F. Kennedy signed into law the Kefauver-Harris Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (1962), which amended the 1938 FDC Act to require, among other things, …
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. …
By Kurt R. Karst – In a decision handed down late in the day on Thursday, September 6th, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia dealt a blow to K-V Pharmaceutical Company’s (“KV’s”) efforts to “restore” orphan drug …
By John R. Fleder – On July 27, 2012, the United States Court of Appeals for the D.C. Circuit issued its long-awaited ruling in Friedman v. Sebelius, No. 11-5028. The case involves a challenge to a decision by the Secretary of Health and Human Services (“HHS”) …
By JP Ellison – In a July 3, 2012 memorandum opinion out of the Eastern District of Pennsylvania, the court granted in part and denied in part the defendants’ motion to dismiss the plaintiff’s claims for failure to state a claim. The case, United States of …
By Benjamin K. Wolf* & John R. Fleder – Dr. Glen R. Justice, a 67 year old oncologist and hematologist, pleaded guilty to defrauding government, public and private insurers out of at least $400,000. The government alleged that Dr. Justice billed for treatments either not given …
Earlier this week, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (“FDASIA”) (usually pronounced “fuh-day-zha”). In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDASIA establishes new user fee statutes for …
By Kurt R. Karst – In a rare lawsuit against FDA involving the Orphan Drug Act of 1983, as amended, K-V Pharmaceutical Company (“KV”) and its wholly-owned subsidiary, Ther-Rx Corporation (“Ther-Rx”), filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in the …
By Kurt R. Karst – In a notice that will publish in the Federal Register later this week, FDA, citing safety concerns, will announce the Agency’s plans to take enforcement action against all unapproved single-ingredient, immediate-release human drug products containing Oxycodone HCl for oral administration, and …
By JP Ellison & Jennifer M. Thomas – If you have ever sat in a meeting, received a letter or brief, or otherwise heard an interpretation from a regulatory agency that surprised, confounded or frustrated you, then you should read the Supreme Court’s recent decisions in …
Hyman, Phelps & McNamara P.C. invites you to register for our webinar, “Garbage Runs, Fake Identities, and Surprise Home Visits: Strategies to Deal With FDA's Nontraditional Investigative Tools,” which is scheduled to take place on Wednesday, June 20, 2012 from 12:30 – 2:00 p.m. ET. From …
