Bass, Berry & Sims attorney Jennifer Michael provided insight for an article in Law360 outlining the latest challenge to the U.S. Department of Health and Human Services (HHS) Office of Inspector General’s (OIG) interpretation of the Anti-Kickback Statute (AKS). Vertex Pharmaceuticals (Vertex), the manufacturer of a gene therapy drug that requires patients to undergo treatment that can cause infertility, sought an advisory opinion from OIG regarding its fertility preservation program. OIG informed Vertex that the opinion would be unfavorable. Although OIG has not yet issued its written opinion, earlier this week, Vertex filed a lawsuit against HHS and OIG seeking a declaration that Vertex’s fertility preservation program does not violate the AKS and setting aside OIG’s opinion that the fertility preservation program implicates the AKS.
Vertex’s suit comes on the heels of challenges to OIG’s interpretation of the AKS filed by Pfizer and the Pharmaceutical Coalition for Patient Access (PCPA). While the Vertex arrangement differs from Pfizer and PCPA’s proposed arrangements in that Vertex would pay for a related service (fertility preserving treatments) rather than provide copayment assistance (like the Pfizer and PCPA arrangements), OIG’s AKS analysis is similar.
Jennifer, the former Chief of the Industry Guidance Branch at the HHS Office of Counsel to the Inspector General (OCIG), told Law360 that Vertex has taken a page out of Pfizer’s playbook by pursuing the “inducement” argument. However, it’s made in a slightly different context because the Pfizer and PCPA challenge involve direct payment assistance. “It looks like they’re trying to create a circuit split, potentially, to allow for review by the Supreme Court,” she said.
The full article, “Vertex Pharma Widens War On Watchdog’s Kickback Views,” was published by Law360 on July 16 and is available online. To read more about Pfizer’s challenge, click here.