At many points in US history, regulatory and legislative bodies have emphasized safety in researching, testing, manufacturing, and distributing drugs. In 1901, the importance of safety in the production of drugs became even more apparent when 13 children who were treated with an antitoxin for diphtheria died of tetanus after it was discovered that the horse from which the manufacturer had derived the serum for the antitoxin had tetanus. After that tragic incident, Congress passed the Biologics Control Act (also known as the Virus-Toxin Law), which give the government control over monitoring the production processes for the manufacturing of biological products.
For years now, safety monitoring has been an important foundation of the process by which biopharma companies get their drugs into market and maintain their license to operate. From laboratory experiments to clinical trials, to the application stage, through long-term safety monitoring, biopharma companies have both a regulatory and ethical responsibility to ensure that the products they are producing are as safe as possible.
And now, with the transformation to value-based care taking hold across the system, biopharma companies are increasingly concerned with how to get their products into market via outcomes-based contracts. Indeed, this was a key takeaway we discovered from in-depth conversations about medical innovation in a value-based care world with 21 leaders from across the health care system. Value-based payment models will shift financial risk from health plans to providers and other stakeholders and change how these stakeholders evaluate innovation.
While we are still early in the move toward value-based care, in this new framework, medical innovation will likely be measured against an evolving definition of value, based on clinical and economic factors, as well as the ability of products to optimize care delivery. As a result, biopharma leaders are shifting their conversations to focus on value over the traditional marketing-centric messages, concentrating now on evidence to support a product’s efficacy, economic value, “beyond the pill” services, and – most importantly – safety.3 The bottom line in these new conversations: Does your product improve patient outcomes?
It is no longer enough for companies to produce safety information about their products and perform ongoing monitoring for the purpose of maintaining compliance and withstanding regulatory scrutiny. The safety data derived from the entire life cycle can and should be used to help companies make critical decisions and manage competing demands while delivering on their number one priority of improving patient outcomes.
This shift may be difficult to navigate for many. Too often, biopharma companies rely on cobbled together processes and siloed technological capabilities designed to address a specific need or issue. Traditional safety systems deliver on traditional needs – helping monitor and evaluate a product’s safety profile – but they often lack the level of integration required to deliver truly measurable impact of a product.
To ensure that safety data is properly and efficiently utilized throughout the cycle of drug manufacturing, companies should consider developing advanced analytics capabilities that support deeper insights and detect patterns and signals using real-time data. Ongoing monitoring and analysis will allow leading organizations to understand the challenges ahead of them – and shift to meet them.
Many biopharma companies recognize that in order to survive the transition to value in health care, their organizations must constantly adapt and begin to leverage non-traditional safety information (e.g., electronic health record data and social media sites) to enhance patient outcomes. Data should be the foundation of that adaptation and the path forward because with better evidence, biopharma companies can produce better results.
PS – Translating better evidence into better results is Deloitte’s theme for the DIA 2016 annual meeting. Explore more here, as Deloitte leaders share insights on key topics facing the discovery, development, and life cycle management of health care products.
3 Terry Hisey and Brett Davis, Pharmaceutical Executive, “Pharma’s Big Push for Value,” May 2016