A recent analysis examines ongoing enforcement risks tied to drug pricing and Medicaid rebate reporting under the Medicaid Drug Rebate Program (MDRP), focusing on a federal court decision addressing how “strength” should be defined for products with the same concentration but different volumes. The court adopted a broader FDA-based definition and dismissed False Claims Act allegations, but the absence of clear statutory or regulatory guidance leaves room for continued scrutiny and potential shifts in agency interpretation. Read the full article for key takeaways on how courts may approach undefined MDRP terms, how FDA regulations can influence rebate reporting obligations, and practical steps manufacturers can take to mitigate False Claims Act risk through consistent, well documented compliance practices.

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