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  • Enforcement

    • FDA Cracks Down on ClinicalTrials.gov Reporting FailuresMay 4th, 2021

      On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov.  The notice was given to Acceleron Pharma, Inc., for failure to submit the required information following completion of a clinical trial evaluating the safety …

    • The Supremes Give the FTC “Nothing but Heartaches”: Court Unanimously Rules No Restitution in Injunction Cases, and How Will This Ruling Impact FDA?April 23rd, 2021

      The Supreme Court has handed down a decision in AMG Capital Management, LLC, et al. v. Federal Trade Commission, No. 19-508 (Apr. 22, 2021) [hereinafter Slip Op.], gutting the FTC’s use of §13(b) of the FTC Act, 15 U.S.C. § 53(b), to obtain equitable monetary …

    • AMPed up—again– over Medicaid Rebate False Claims Act allegationsApril 13th, 2021

      Earlier this month, the Department of Justice announced another settlement in a Medicaid Rebate False Claims Act (FCA) case.  In this case, United States ex rel. Streck v. Bristol-Myers Squibb Co., Civil Action No. 2:13-CV-7547 (E.D. Pa)  Bristol Myers Squibb (BMS) agreed to pay $75 …

    • Keeping Up With the Kardashians – OPDP EditionMarch 11th, 2021

      I would be lying if I said I hadn’t expected this most recent OPDP Untitled letter.  OK, maybe not THIS letter.  Some background: Back in November 2020, after an article was published about the ethical questions surrounding “Sponcon,” (sponsored content – for those not hip …

    • OPDP Issues Second Warning Letter of 2021. But Wait, Where Did the OPDP Warning Letters Go?March 2nd, 2021

      Well, it’s been busy for OPDP (and the Rx Ad/Promo bloggers over at the FDA Law Blog).  After getting off to a slow start in 2021, OPDP issued yet another Warning Letter, apparently the day after its first.  Unlike the first letter, this OPDP Warning …

    • The Future of EUAs: What Happens Post-CrisisDecember 7th, 2020

      Hyman, Phelps & McNamara, P.C.’s Anne Walsh will be presenting on The Future of EUAs: What Happens Post-Crisis, as part of this year’s Food and Drug Law Institute’s virtual Enforcement, Litigation, and Compliance Conference on December 15-16.  Hear from your peers about how they are staying …

    • FDA Law Alert – December 2020December 4th, 2020

      To close out 2020, Hyman, Phelps & McNamara, P.C. is pleased to present the latest issue of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and enforcement …

    • In a Surprise Move, the Trump Administration Ends FDA’s “Unapproved Drugs Initiative”November 23rd, 2020

      If your 2020 FDA BINGO card included the end to FDA’s Unapproved Drugs Initiative, then, BINGO!  Late last Friday, the Department of Health and Human Services—but not FDA—announced a forthcoming Federal Register Notice withdrawing both the 2006 (Docket No. FDA-2003-D-0030) and 2011 (Docket No. FDA-2011-D-0633) …

    • Lemonade from Lemons: Fairness in FDA Enforcement ActionsOctober 20th, 2020

      Although it is difficult to glean much positive during these COVID-times, particularly if you are (or could be) the subject of a government enforcement action, this post attempts to provide a possible silver lining.  As part of an effort to support economic recovery during this …

    • Restitution and Disgorgement Authority Under FTC Act Section 13(b) Rejected – AgainOctober 5th, 2020

      The Third Circuit handed down a precedential decision this week in the case of Federal Trade Commission v. AbbVie Inc., et al., No. 18-2621 (3d Cir. Sept. 30, 2020), ruling that the District Court for the Eastern District of Pennsylvania erred in requiring AbbVie and …

    • A Couple of Firsts in Food EnforcementSeptember 22nd, 2020

      Last week brought a reminder that the government can bring to bear a range of legal theories – some old, some new – in pursuing alleged violations of food safety requirements. The U.S. Department of Justice (DOJ) announced a sentence levying $17.25 million in criminal penalties …

    • Why Aren’t FDA Drug Facility Inspections Resuming?June 25th, 2020

      It has been over three months since FDA issued its press releases stating that it was postponing most foreign and domestic facility surveillance inspections (see here and here).  Since then, apparently only “mission critical” surveillance inspections have taken place, leaving the bulk of registered facilities …

    • Much-Needed Clarity on Disgorgement from the Supreme CourtJune 24th, 2020

      A Supreme Court decision this week shows good potential to upend FDA and FTC’s claim that they can without limits seek disgorgement of “profits” from defendants who engage in unlawful activities.  In Liu v. Securities and Exchange Commission, the question was whether the SEC could …

    • Pricing in the Time of Price Gouging: Trying to Find a Safe HarborMay 5th, 2020

      As unfortunately happens during every national disaster or emergency, unscrupulous individuals and companies see an opportunity to make money.  A lot of it.  When that happens, there are always immediate calls to prosecute individuals and companies for “price gouging” certain products and taking advantage of …

    • Swift Enforcement Against COVID FraudstersMay 1st, 2020

      Since HHS declared a public health emergency caused by COVID-19 in February 2020, there has been an overwhelming response to develop and market products to treat or mitigate the effects of the virus.  Unfortunately, bad apples still are out there preying upon consumer fears and …