As demand for evidence about the clinical and economic benefits of new treatments continues to grow, Food and Drug Administration (FDA) regulations on communications by biopharmaceutical companies remain rooted in the past and limit companies’ ability to meet these needs. A new Forbes op-ed by Dr. Scott Gottlieb highlights the negative consequences for patients and the health care market.
A range of efforts are underway to shift the U.S. healthcare system toward value-based care such as the new payment models being tested by the Center for Medicare and Medicaid Innovation to reduce spending and improve the quality of care, a framework for evaluating medical oncology treatments recently announced by the American Society of Clinical Oncology, and a Learning Action Network to inform payment reforms launched by Health and Human Services.
In his op-ed, Gottlieb highlights a restriction on biopharmaceutical companies’ ability to support this shift to value – specifically limitations on companies’ ability to communicate information, including cost effectiveness data, on approved treatments when that information is not included in the package insert approved by the Agency. While Gottlieb’s column focuses on the harmful effects of FDA’s failure to implement a provision of the 1997 FDA Modernization Act (FDAMA) related to healthcare economic information, it underscores a broader point – biopharmaceutical research companies will be hampered in their ability to support the move to value-based care if outdated FDA regulations impede their ability to communicate truthful and non-misleading information to payers and other entities that have incentives to control healthcare costs. “The end result is that there is less incentive to develop this data in the first instance,” Gottlieb writes. “Even if drug makers had rigorous data looking at the comparative risks and benefits of their medicines against cheaper alternatives, it’s unlikely they could share the economic aspects of these results under current FDA rules.”
Gottlieb’s op-ed cites results of a recent survey of 14 pharmaceutical companies by Avalere Health to better understand the impact of FDA regulations on the development and distribution of healthcare economic data. Not surprisingly, the survey found that 86% of companies indicated that they would invest more in research if FDA provided overdue guidance to implement the relevant provision of FDAMA. This information could help payers and providers make better treatment decisions, as they utilize information for a growing array of sources such as oncology value assessment tools, electronic clinical decision support tools and even, as highlighted by a recent Wall Street Journal article, information from social media.
Writing about the survey findings, Gottlieb explains, “The majority of respondents indicated that lack of FDA guidance or regulations outlining what economic information drug makers can share have impacted their organizations’ development of economic information related to their products… Absent a viable path to share this information, it follows that there will simply be less of it. This will reduce competition, and leave consumers, physicians, and the entities that purchase medicines with less information to inform their decisions.”
As the biopharmaceutical industry endeavors to advance and embrace 21st century science, governing regulations are preventing the industry from supporting the shift to value-based healthcare. As with new treatments, new information will be useless if it is not available to the people who need it. A robust exchange of accurate, data-driven information could help further medical knowledge, support good decision-making and, most importantly, improve patient outcomes.
Randy Burkholder Randy Burkholder is Vice President of Policy and Research at PhRMA. He has over 17 years experience in health care policy, advocacy and communications in the medical technology and pharmaceutical industries.