Enabling U.S. Biopharmaceutical Innovation

Lengthening and improving human lives is an important mission, but also one that is both difficult and expensive.  At the core of that mission is a vibrant, thriving and innovative biopharmaceutical industry and the modern medicines it brings to market. Yet, biopharmaceutical innovation, the foundation for producing these medicines, is a process defined by uncertainty, complexity and, all too often, failure.  Moreover, biopharmaceutical innovation plays a critical role in the long-term health of our economy.

Biopharmaceuticals have time and again been demonstrated to be the most cost-beneficial intervention in healthcare. Why, then, is the discussion around private and government decision-making on pricing and reimbursement for healthcare increasingly focused on pharmaceutical costs alone?   Why are we not talking about what is gained by investing in longer, healthier lives and less human suffering?   Why is there significantly less focus on the public policies required to facilitate and maintain a dynamic bio-pharmaceutical innovation economy in the United States?  The current cost versus value discussion has not tackled a key question: How can policymakers continue to enable biopharmaceutical innovation?

To ensure that the United States maximizes public and private investments in biomedical innovation three broad principles ought to be addressed:

One, to stimulate investment in bio-pharmaceuticals we need to build new paradigms in policies such as intellectual property protection, collaboration between private and public research organizations to optimize the role of both in research and development, access to medicines and treatments even the sickest patients need, provide access to appropriate data sets and allow collaborative efforts with academia. All this is necessary while we also put in place effective trade and tax policies.

Second, in addressing the drug approval environment, there needs to be more streamlined and decisive regulatory bodies and processes. At times, the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), to cite two examples, engage in areas outside the scope of their mandates such as utilizing cost as a parameter in evaluation or approval of new therapies. We also need more innovative clinical trial designs and recruitment, including the use of Real World Data, and a regulatory framework which understands the complexity of manufacturing. Such complexity certainly includes the inevitable introduction of biosimilars in this country.

Finally, we need to have a robust access strategy for new therapies. Policies need to shift to allow for the ability to look at costs more dynamically than the current system of siloed reimbursement schemes that do not consider overall cost savings or improvements in quality of care and life for patients. This includes addressing an outdated insurance model. We need to develop appropriate quality measures to ensure that new payment models are not harming patients or shifting inordinate costs for new innovations to those who suffer. There are also barriers to communication with external audiences that hinder access to exchange of appropriate scientific data with interested parties which ultimately hurt access to innovative therapies. And we need to address long term issues such as compliance/adherence which, if ignored, will not allow society to fully garner the benefit from the use of new technologies.

All too often policymakers take a bumper sticker approach to supporting innovation, such as increasing funding for government-sponsored research or fixing the FDA bureaucracy. Ultimately, biopharmaceutical innovation requires attention to a complex set of intersecting public policy issues – intellectual property protection, tax and trade policies, pricing and reimbursement and access to Real World Data.  If we are not successful in addressing each of these critical issues, we will miss the opportunity to usher in a new golden age of medicine and fall short of our duty to help those who are sick and whose lives could be vastly improved and extended by the hope of biopharmaceutical innovation.

Robert Popovian is the Senior Director of Pfizer US Government Relations.