Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued the following statement:
“As the U.S. health care system evolves to become increasingly focused on value, patients, payers and providers seek more science-based safety, effectiveness and economic information about existing and emerging treatments for patients. The market for medicines is changing rapidly as alternative payment models proliferate and novel decision tools like value frameworks are being applied. Increasingly, prescribing decisions are made not by independent physicians, but influenced by the integrated delivery systems in which they practice or by financial incentives created by powerful health plans. In this changing environment, it is important that biopharmaceutical companies be able to share appropriate science-based information with population health decision makers, yet the U.S. Food and Drug Administration’s (FDA) current federal regulations have not kept up with this new reality.
“As outlined in PhRMA’s Principles on Responsible Sharing of Truthful and Non-Misleading Information, greater sharing of information between biopharmaceutical companies, payers and health care professionals can benefit patient care and insurance coverage by allowing decisions to be based on more complete information about medicines. The Principles serve as a responsible model for the type of regulatory changes the FDA is considering.
“Given our increasingly data-driven, value-based health care system, we hope the FDA will adopt a stepwise approach in defining new and clearer regulatory standards to permit responsible sharing of information and data about medicines with other parties in the health care system. The FDA should start by clarifying rules around information sharing with insurance companies and other population health decision makers by the end of the year. Such clarification – also requested by stakeholders in the insurance industry – will help improve the efficiency of our health care system and facilitate increased value-based care”