• where experts go to learn about FDA
  • Anne K. Walsh

    • When Refusing a Picture During a Food Inspection Could Prove CostlyOctober 27th, 2022

      The question of whether FDA has authority to take pictures during an inspection of a facility has bounced around the food and drug bar for many years. FDA’s view is stated in the agency’s Investigation Operations Manual, and it is one with which a number …

    • Fraud-on-the-FDA As A Basis for A False Claims Act Lawsuit: Is It Dead Or Just Resting?June 13th, 2022

      Legal doctrines can be like parrots.  Sometimes it is hard to know if they are dead or just resting. Under the False Claims Act (FCA), if a company’s fraudulent conduct induces a governmental entity to enter into a contract with the company, then any claims for …

    • Are You Recall Ready? FDA Expects You to BeMarch 21st, 2022

      All companies dread the logistics, cost, and reputational harm associated with conducting a recall when necessary to remove or correct products in the field.  But the more prepared a company is for a potential recall, the less pressure it will feel when a situation necessitates …

    • FDA Proposes to Harmonize the Quality System Regulation with ISO 13485March 7th, 2022

      On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR).  The QMSR omits many of the specific QSR requirements that …

    • “The Name’s Bond. James Bond.”: DOJ Requires Companies to Identify All Responsible IndividualsNovember 15th, 2021

      It may be just a coincidence that DOJ released its latest policy pronouncement at the same time as the final “Daniel Craig as James Bond” movie.  But like James Bond, companies in the crosshairs of a government investigation have No Time to Die, as they …

    • Giving Regulatory Due Diligence Its DueSeptember 2nd, 2021

      The adage that “no one is perfect” applies as equally to companies as it does to people.  Before committing to a merger or acquisition with another company, a potential Buyer must conduct due diligence to identify the imperfections of a target company so the Buyer …

    • DOJ Re-Brands Guidance DocumentsAugust 30th, 2021

      Companies often use rebranding to reposition and refocus their business.  Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally.  The federal government does its own version of rebranding with each change in administration.  Just before the July 4 holiday weekend, …

    • FDA Medical Device Ban Overturned For the First TimeJuly 7th, 2021

      In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban.  In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to …

    • Ninth Circuit Allows Fraud-on-the-FDA Claim in FCA Whistleblower Suit Against Medtronic, But Affirms Dismissal of Off-Label Promotion ClaimApril 8th, 2021

      On April 2, 2021, the Ninth Circuit issued a decision in a False Claims Act (FCA) case against Medtronic.  The Dan Abrams Co. LLC v. Medtronic Inc., No. 19-56377, 2021 U.S. App. LEXIS 9637  (9th Cir. Apr. 2, 2021).  Relator appealed the U.S. District Court …

    • FDA Warns Against Use of Registration Certificates: It Don’t Mean A ThingMarch 5th, 2021

      It’s not just drug companies that push the limit on marketing their products – see our posts about recent OPDP warning letters.  Medical device companies are fighting for any edge to differentiate their products too.  Even before COVID-19 brought an onslaught of new players to …

    • When Will the Emergency End?January 11th, 2021

      It’s a burning question: when will we return to normal?  And although the answer is hugely subjective, this post focuses on the date the official emergency declaration for COVID-19 will terminate.  Despite the general sentiment that we want to be back to normal sooner rather …

    • 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 …

    • Courts Reject Demands to Force FDA to Approve Hydroxychloroquine for COVID-19October 1st, 2020

      Two federal courts, in unrelated cases, separately rejected plaintiffs’ attempts to force FDA to authorize the use of hydroxychloroquine to treat or prevent COVID-19.  Hydroxychloroquine, a drug that has been used for over 60 years, has been touted by President Trump as an effective treatment …

    • 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 …

    • 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 …