The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. How will the cuts at FDA impact inspections and enforcement? Will there be a heightened appetite for mergers and …
On January 7, 2025, FDA announced that back on November 12, 2024, the Center for Veterinary Medicine (“CVM”) issued Warning Letters to six online retailers marketing unapproved new animal drug products that purported to treat and control seizures and epilepsy in dogs and cats. At …
This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these “lessons” will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. Although FDA has long taken the …
A recent Warning Letter reflects an FDA citation of a company for refusing to permit FDA Investigators to take photographs during an inspection. We haven’t seen an FDA Warning Letter citing a refusal to permit photographs for years, so, just as FDA is apparently reviving …
It took only 3 months. In June, the Supreme Court ruled that the SEC cannot use its administrative authority to impose civil penalties for securities fraud on the ground that these penalties violate the U.S. Constitution’s Seventh Amendment right to a jury trial. See SEC …
FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. (AbbVie), for a direct-to-consumer (DTC) TV advertisement for its drug UBRELVY (ubrogepant) that features tennis star, social media influencer and entrepreneur Serena Williams. This …
While we hope readers of the Blog, as our clients and friends, come out of any FDA inspection with a clean bill of health, we know that based on FDA FY2024 data to date, approximately 40% of inspections of medical device companies end up classified …
FDA’s Office of Prescription Drug Promotion (OPDP) has issued two new Untitled Letters this summer after 5 months without any letter activity. The letters are vastly different from one another in subject matter, but together they make a cruel summer of OPDP enforcement against industry. …
On Thursday, the 27th of June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy. The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the …
Among the tools that the government has to enforce the FDC Act is the injunctive power granted by Congress in 21 U.S.C. § 332. That statute provides that courts “shall have jurisdiction, for cause shown, to restrain violations” of the FDC Act. Historically, courts have …
Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance …
Today’s email brings an interesting, and somewhat confusing settlement of what should have been an ordinary antikickback statute case, and may bring about a clash between what many companies do and what the government may be objecting to. Or, perhaps your loyal blogger is reading …
While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. Inspections went down—way down—during the pandemic. In March 2020, FDA temporarily postponed all foreign and domestic and …
Hyman, Phelps & McNamara, P.C. (HP&M) proudly announces that Director Anne Walsh will be a featured panelist at the highly anticipated 2024 Women’s White Collar Defense Association (WWCDA®) Leadership Retreat and Annual Attorney Meeting. The event is set to take place from March 4-6, 2024, …
As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. Interest rates may be on the way down, which in turn may …
