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 …
We have written on this blog about FDA’s modernization agenda from several angles lately—from the psychedelics Executive Order to the peptide compounding landscape (part 1, part 2)—but here is a storyline that cuts to the operational heart of regulated industry (or at least appears to): FDA …
It’s been a month since DOJ announced the “first-ever Department-wide corporate enforcement policy” for criminal matters. Touted as a means of “promoting uniformity, predictability, and fairness” in how DOJ pursues white-collar cases against corporate defendants, the new “Corporate Enforcement and Voluntary Self-Disclosure Policy” (CEP) sets …
If you’ve been tracking FDA’s international presence, you know FDA has been through a bit of a roller coaster over the past decade. After consolidating from 13 foreign offices down to 8 between 2012 and 2014—and losing its Pretoria, South Africa office in 2015—the Agency …
Here’s a puzzle: You can sue FDA to challenge a decision on a Citizen Petition, because it is final agency action. See 21 C.F.R. § 10.45(d). Courts have held that you ordinarily cannot sue FDA to challenge Warning Letters, because they generally do not rise to the …
As prosecutions for manufacturing and distributing counterfeit drugs continue to rise with enhanced investigatory tools and federal statutes (see DEA’s recent announcement on “Operation Meltdown”), courts are grappling with how to fashion appropriate sentences. Last week, the Sixth Circuit Court of Appeals affirmed the 90-month …
Monday was an eventful day for the parties and practitioners alike who are closely following the ongoing legal challenges to FDA’s attempt to impose civil penalties on businesses alleged to be selling unauthorized e-liquid tobacco products. The day included oral arguments at the Fifth Circuit …
On January 27, 2026, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a Special Advisory Bulletin addressing direct-to-consumer (“DTC”) prescription drug programs. These DTC programs allow cash-paying patients, including those enrolled in Federal health care programs such as Medicare …
Hyman, Phelps & McNamara, P.C. Director Kalie E. Richardson will be moderating a Food and Drug Law Institute webinar this coming Wednesday on Ensuring Effective Responses to FDA 483s and Warning Letters. This webinar will cover fundamental considerations for responding to FDA 483s and Warning …
