Assuring Adequate Veterans Health Funding
Simon&Co. worked with veterans’ services organizations under the leadership of the Disabled American Veterans to propose an alternative funding mechanism for veterans’ health. Simon&Co. recommended changing the Department of Veterans Affairs healthcare budget to an advance appropriation, providing veterans health funding for two years and allowing timely health systems planning. This approach was adopted into law by the passage of the Veterans’ Health Care Budget Reform and Transparency Act in 2009, as President Obama called it, “the most significant legislative victory for veterans in a generation.”
Achieving an FDA Solution for a Biotech Startup
Simon&Co. supported a biotechnology start-up company’s successful effort to negotiate an agreement allowing the client’s product to remain on the market after an unprecedented and unexpected Food and Drug Administration (FDA) product reclassification. While the product was initially regulated as a tissue–with no adverse events or safety signals reported–the FDA decreed that the product must be reclassified as a biologic, approval of which entails a multi-year review. For a small start-up, this was a devastating prospect, destroying jobs and removing a product in use in the field by the Department of Defense in Afghanistan. Working with Congress, Federal agencies, patient advocates, and other stakeholders, Simon&Co. convinced the FDA decision makers that the product must be allowed to remain on the market while the company conducted clinical trials.