Patients, providers, and state and federal regulators are struggling with innumerable questions in the face of the COVID-19 pandemic. How do I get tested? Where can I find my next shipment of personal protective equipment? How can we lessen the burden on our healthcare systems, businesses, and citizens? There are no simple answers. However, there is one thing that is critical to the response strategy: planning. Planning will enable companies to find a seat at the table, whether to discuss a potential new product with the Food and Drug Administration (FDA) or to secure state or federal stimulus funding.
The pharmaceutical, medical device, and healthcare industries represent the front-line efforts in dealing with both patient treatment and product development. Pharmaceutical and device companies have undertaken significant research and development activities to address the pandemic in a matter of mere weeks and have recently warned governments to provide additional upfront funding related to treatments, vaccines and testing. FDA has been flexible in encouraging these development activities and interactions, providing near real-time guidance and responses.
The most successful companies have committed time and resources to gather information, assess the current situation, and plan their actions accordingly, recognizing that both short-term and long-term needs exist. In a time of crisis, it is not realistic to assume that FDA – which has been dealing with public health crises at various times for decades – will suddenly approve a product that is ill-conceived or inadequately tested. Despite its accelerated review pathways and interactions with industry, FDA must still adhere to its public health mission by only allowing safe and effective products on the market.
Likewise, the most successful companies across industries are those that not only understand the regulatory process, but also how to accomplish their goals in Washington. Congress is considering additional stimulus funding that will continue to impact most business sectors in the U.S. Despite these extraordinary times, the ordinary work of agencies and the government continues as well. Companies that understand how to work in Washington – at the speed of Washington – and how to present their and their industry’s needs, are more likely to be heard when decisions are made. Companies are lining up to make sure their voices are heard, and those that do not risk losing their seat at the negotiation table. Now is the time to plan for both short-term pandemic response and long-term pandemic recovery.
Buchanan can help companies on both fronts, including navigating the Washington landscape. We have assembled teams comprised of Government Relations professionals and attorneys to guide clients on the impact and direction of current and future stimulus funding, coupled with the legalities of obtaining and implementing the provisions once they become law. Our attorneys are also poised to guide companies through the regulatory issues they face not only from FDA but from any agency. The breakneck speed of COVID-19-related decisions and developments requires the kind of Washington insight that Buchanan is prepared to provide.