FDA Law

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

Consulting 52

Consulting Manufacturing Provider Specialization 52

FDA Law

JUNE 7, 2023

Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in the pharmaceutical, device, and biologics space that benefit from reimbursements from Federal health care programs. The FCA incentivizes whistleblowers to come forward by awarding them a cut of any recovery.

Government 40

Government Patient-Centered Manufacturing IT 40

FDA Law

SEPTEMBER 30, 2022

Kirschenbaum — In November 2020, we blogged about a decision by the Federal District Court of Maryland dismissing a Federal False Claims Act (FCA) qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP), resulting in underpayment of rebates.

Manufacturing 40

Manufacturing Insurance Specialization Government 40

FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. We will discuss these actions in more detail in later blog. 44,710, 44,716 (July 24, 2020).

Management 40

Management Manufacturing Specialization IT 40

FDA Law

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. The case law on commission-based marketing agentsincluding the Sorensen decisionfollow in a similar vein. Marchetti , 96 F.4th

Referral 59

Referral Relationship Government Healthcare 59

FDA Law

MAY 11, 2023

Koblitz — Well, we’re a little late to blogging about this, but the significance of the ongoing Teva v. GSK litigation to Hatch-Waxman aficionados makes this case still ripe for blogging. government in the now-infamous (at least in FDA circles) Teva v. government in the now-infamous (at least in FDA circles) Teva v.

Government 72

Government Manufacturing IT Utilities 72

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law

MAY 23, 2025

During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. Radical Transparency. Deregulation Efforts.

Manufacturing 59

Manufacturing Specialization IT Provider 59