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to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance …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 …
Primacy and recency are recognized psychological phenomena: people tend to remember the first thing they hear, and the last. It’s why litigators concentrate on their opening statement to a jury, and their closing argument. Maybe that’s also why FDA last week publicized the highest number of …
It has been a few weeks, but we thought it important to do a deeper dive on the two Office of Prescription Drug Promotion (OPDP) Untitled Letters published in November. The letters, both issued on October 31, 2023 but published in early November, were to …
The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special …
The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), as well as other experts from FDA, DOJ, and the private sector. HPM Director Anne Walsh will moderate a panel discussion on “Due …
Although the Consumer Product Safety Act (CPSA) has been around for over 50 years to “protect the public against unreasonable risks of injury associated with consumer products,” it was not until 2008 that the statute was amended to authorize the Consumer Product Safety Commission (“CPSC”) …
The word last week was that FDA is re-organizing the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER). It is the latest item on a long list of similar initiatives that have marked 2023. Those efforts add up to …
We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April …
