Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines. We are thinking of all of you in these difficult times, and hope that you and your loved ones are healthy and safe.

Industry Insights

OTC Monograph Fees Announced… Not So Fast!
By: Carolina M. Wirth and David Wilson of Reed Tech

On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter Monograph User Fee Act (OMUFA) Program for Fiscal Year 2021. Reed Tech contributors Carolina Wirth and Genevieve Razick, both of Arnall Golden Gregory, LLP, quickly digested the information and summarized the OMUFA program. More importantly, the authors provided some information regarding the types of facilities that were impacted by these fees. You can read the full bulletin here. However, less than a week later, the Department of Health and Human Services (HHS) published a withdrawal of the notice creating a lot of uncertainty within the industry. According to the withdrawal notice, “FDA lacked the delegated authority” to issue the Federal Register notice and, as such, the agency was “ordered to cease further collection efforts.” More >

Beware Sponsored Events and Honoraria: A FCPA Trap for the Unwary
By: Michael E. Burke

Under the U.S. Foreign Corrupt Practices Act (FCPA), foreign health care professionals (HCPs) are considered “foreign officials” for purposes of the statute’s antibribery prohibitions and recordkeeping requirements. On November 16, 2020, the Department of Health and Human Services – Office of Inspector General released a Special Fraud Alert regarding Speaker Programs. While the Alert is specific to the Anti-Kickback Statute, U.S. life sciences companies should use the Alert’s recommendations to minimize FCPA risk given the FCPA enforcement theories and actions undertaken by the Justice Department. More >

Pharmaceutical Companies Beware: New Final Rule Changes Existing Anti-Kickback Statute Discount Safe Harbor Provisions
By: Rebekah N. Plowman and Genevieve M. Razick

In November 2020, the Department of Health and Human Services (HHS) finalized a regulation aimed at lowering prescription drug prices and out-of-pocket spending for prescription drugs by excluding rebates on prescription drugs paid by manufacturers to or purchased by Medicare Part D plan sponsors or pharmacy benefit managers (PBMs) acting under contract with Medicare Part D plan sponsors from the existing discount safe harbor under the federal Anti-Kickback Statute (AKS). The regulation reflects the first change to the AKS discount safe harbor since the Medicare Part D program was established. In addition to the rebate exclusions, two new safe harbors were added. More >