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Private Equity Firm Settles with DOJ in False Claims Act Matter Based on Claims Submitted by Its Health Care Portfolio Company

Compounding pharmacy Diabetic Care Rx, LLC d/b/a Patient Care America (“PCA”), two individual executives, and the pharmacy’s private equity fund owner, Riordan, Lewis & Haden, Inc. (“RLH”) recently reached a $21 million settlement with the U.S. Department of Justice (“DOJ”) to resolve allegations that the parties engaged in an illegal kickback scheme resulting in submission of false claims to the government in violation of the False Claims Act (“FCA”).

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Proposed Legislation Would Authorize FDA To Approve Follow-on Biologics


Time to Read: 1 minutes Practices: Life Sciences

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The "Access to Life-Saving Medicine Act," introduced in late September, would authorize the Food and Drug Administration to approve follow-on biologics that closely resemble previously approved biological products. In its current version, the bill provides manufacturers of follow-on biologics with virtually everything they could ask for. The bill gives FDA substantial discretion to approve follow-on biologics and, in sharp contrast to the current legislative scheme governing drugs, the bill would not afford innovator companies any period of marketing exclusivity whatsoever for their biologic products. As a result, the manufacturers of previously approved biological products would be well-served to follow the forthcoming legislative debate on this issue very closely. For more on the bill and its various provisions, please click "Download PDF" to read Ropes & Gray's client alert.

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