Well, readers, we finally have an answer. Or at least an interim answer. And, yes, it comes with “guardrails.” After the July 23-24, 2026, Pharmacy Compounding Advisory Committee (PCAC) meeting left compounders asking whether (and when) FDA enforcement discretion would follow the favorable peptide votes, …
On October 22, 2026, the DOJ Civil Division and the Department of Health and Human Services (HHS) announced a six-month pilot program that offers “legitimate American healthcare businesses” a defined path to come clean on potential False Claims Act (FCA) violations, in exchange for a …
Yes, we know — the O.N. Diagnostics Warning Letter has already been thoroughly covered since FDA posted it on October 6. We waited for the dust to settle, since we think software companies will be living with the implications of this letter for quite some …
On October 20, 2026, the Department of Justice unveiled the Fraud Whistleblower Incentive Program (WHIP), formally the National Fraud Enforcement Division Criminal Tip Rewards Pilot Program (the “Program”) — a three-year pilot that pays an up-front reward of $10,000 to $30,000 for tips leading to …
For the third time in this Administration, DOJ is directing its prosecutors to “take an aggressive, all-tools approach to investigating and prosecuting” certain categories of fraud. Unfortunately, the health care and life sciences space has been singled out, and remains solidly in the crosshairs for …
On September 10, 2026, the U.S. Attorney’s Office for the District of Massachusetts announced that Dompé U.S., Inc. agreed to pay $32 million to resolve allegations that it used patient assistance foundations to cover Medicare co-pays for patients receiving Oxervate, a biologic used to treat …
On August 31, 2026, FDA and the Securities and Exchange Commission (SEC) announced a new Memorandum of Understanding (MOU) intended to enhance cooperation between the agencies and facilitate the exchange of non-public information relevant to their respective oversight and enforcement responsibilities. The agreement runs for …
For anyone who thought FDA’s Office of Prescription Drug Promotion (OPDP) had lost interest in pre-approval promotion, think again. On August 21, 2026, OPDP issued an Untitled Letter to Alar Pharmaceuticals concerning promotional claims for ALA-3000 injection, an investigational extended-release ketamine product being developed for treatment-resistant …
For the first time, the Department of Justice has backed off its prior vigorous defense of FDA’s tobacco product administrative Civil Money Penalty (CMP) scheme as constitutional under the 7th Amendment and Jarkesy. Earlier this week, the Solicitor General sent a letter to Congress saying that it …
Last week FDA publicly posted the first Quality Management System Regulation (QMSR) Warning Letter and this week it posted the second. The QMSR went into effect in February of this year. For months, we have seen the top 483 citations shift in FDA’s inspection database …
FDA clinical investigator Warning Letters often involve familiar GCP themes, including protocol deviations, inadequate records, and insufficient oversight. FDA’s recent Warning Letter to a Florida clinical investigator following a Bioresearch Monitoring Program (BIMO) inspection is notable not because it breaks new regulatory ground, but because …
Keeping with the 2026 pace of issuing at least two letters a month, the Office of Prescription Drug Promotion (OPDP) has issued letters 20 and 21 this July, and it’s pretty clear to these bloggers that these summer letters are the “filler” to keep up …
Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce that Abdie Santiago has joined the firm as an Associate. Mr. Santiago advises healthcare and life sciences clients on a broad range of healthcare regulatory and compliance matters, including fraud and abuse issues, federal drug pricing …
On May 1, 2026, the House Committee on Appropriations submitted House Report 119-632 to accompany H.R. 8646—the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2027, which passed on June 4, 2026. The report serves as the Committee’s …
On June 15, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Happiest Baby, Inc., the manufacturer of the SNOO Smart Sleeper bassinet system, following a July 2025 inspection of the company’s Los Angeles facility. The Warning Letter highlights several key …
