BIO filed an amicus brief in the U.S. Court of Appeals for the District of Columbia Circuit, seeking the reversal of a lower court decision that found plaintiff Vertex Pharmaceuticals’ patient assistance program in violation of the Anti-Kickback Statute.In this case, Vertex established an assistance program that would provide financial support for fertility preservation services to patients prescribed the company’s cell and gene therapy —developed to treat the congenital blood disorders of sickle cell disease and transfusion-dependent beta-thalassemia.Cell and gene therapies can be highly innovative and life-changing for patients, providing potentially curative treatments for severe and difficult to treat diseases, like sickle cell disease. However, administering cell and gene therapies is often an intensive and sometimes months-long process, including requiring preparatory treatments. Specifically, a patient's immune function needs to be suppressed to help prevent rejection of new cells and genetic material post-infusion. This immune suppression is commonly achieved through chemotherapy, which poses many serious health risks, and in this case, included infertility.The brief asserts that the district court erred in its decision, not only by misinterpreting statutory language, but also by applying an overly broad interpretation of the statute, thereby potentially criminalizing an assistance program that simply aimed to mitigate a serious side effect associated with treatment