Reflections on the “New Biotechnology and Pharmaceutical Industry Commitment to Patients and the Public”

We read with great interest the Opinion piece in Stat News in which more than 200 corporate leaders—mostly from small and mid-sized companies, as well as some investors—signed on to what they called a “A New Biotechnology and Pharmaceutical Industry Commitment to Patients and the Public.” The Commitment outlines an aspirational approach to drug development and “putting the interests of patients first,” with activities focused in two main areas: Ensure Access and Act with Integrity and Responsibility.

We read with equal interest the comments on the article, which ranged from the cynical to the hopeful. Commenters reflected a “wait and see” attitude, and several questioned what such a commitment actually meant in practical terms. Put another way, the “what” and the “why” of the commitment was generally outlined, but there was a notable absence of details around the “how” that did not go unnoticed—including both the “hows” of the initiative’s creation, and details around both execution and accountability. What was the impetus for the document’s authors? How were signers engaged? What mechanisms will be established to ensure signers live up to their commitment?

Given that lack of transparency is one of the most significant issues raised by advocates and patients in the realm of drug development, we think that it will be crucial to the success of this initiative for its leaders to not only share the thinking behind its development, but also to invite collaboration with the communities it purports to serve as the initiative continues to evolve.

We will be encouraging and supporting our clients to align with these laudable principles. At the same time, we will be monitoring the evolution of this New Commitment and the activities of its signers, in hopes that we truly have reached a “pivotal moment in the history of our industry,” where all stakeholders in drug development have a seat at the table and that we can work together to fulfill the “moral obligation to develop the best medicines and ensure that every person who may benefit has access to them.”

Stay tuned.