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. …
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Enforcement
- The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not WarrantedSeptember 18th, 2012
- KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17PSeptember 6th, 2012
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 …
- D.C. Circuit Decides Case Involving Exclusion of Former Purdue ExecutivesJuly 27th, 2012
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”) …
- Lack of Regulatory Guidance Fatal to Some, But Not All Claims in AMP False Claims Act CaseJuly 19th, 2012
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 …
- Debarred By FDA! For What? For How Long? Really?July 17th, 2012
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 …
- FDASIA Enacted; HP&M Issues Detailed Summary and AnalysisJuly 11th, 2012
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 …
- FDA Sued for Abrogating MAKENA Orphan Drug Exclusivity; Suit Alleges that FDA is Turning a Blind Eye to Compounded 17P and Bowing to Political PressureJuly 8th, 2012
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 …
- FDA Announces Intent to Take Enforcement Action With Respect to Certain Marketed Unapproved Oxycodone Drug Products; Denies Lannett “Grandfather” Drug PetitionJuly 6th, 2012
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 …
- Supreme Court to Regulatory Agencies: Due Process Requires “Fair Notice” of Agency InterpretationsJuly 1st, 2012
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 …
- HP&M Webinar: Garbage Runs, Fake Identities, and Surprise Home Visits: Strategies to Deal With FDA’s Nontraditional Investigative ToolsJune 17th, 2012
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 …
- Court Rejects FTC’s Effort to Require Two StudiesJune 13th, 2012
By Riëtte van Laack – As we previously reported, the United States District Court for the Southern District of Florida denied the Federal Trade Commission’s (“FTC’s”) motion to hold Garden of Life and its founder, Jordan S. Rubin (collectively “GOL”) in contempt for allegedly violating a court-issued …
- FDA Misdemeanor Cases—Not Always A Sure Win for the GovernmentJune 4th, 2012
By John R. Fleder – It is often said that a grand jury would indict a ham sandwich if asked to do so by a prosecutor. Some lawyers also say that the government cannot lose an FDA misdemeanor prosecution against current and former company officials because …
- House Passes FDA Reform Act of 2012; Next Up – Conference CommitteeMay 31st, 2012
By Kurt R. Karst – After a round of congratulatory speeches, the U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. Unlike the U.S. Senate, which passed its version of the bill …
- 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, …
- Abbott’s Resolution of Off-Label Allegations Has Familiar and New Elements to ItMay 22nd, 2012
By JP Ellison – Virtually all of the mainstream and trade press outlets have covered the recent Abbott resolution with the U.S. Department of Justice regarding allegations of off-label promotion of Abbott’s drug Depakote. Undoubtedly, the $1.5B price tag and that coverage have made most readers …