https://morningconsult.com/opinions/rewarding-value-means-sharing-information/

If you wanted to know the headlines in 1962, you watched the evening news, read the daily newspaper, or listened to the radio. Those were your only options.

But if you want to know the headlines today, the range of sources available to you is nearly limitless.

As news has evolved, we also have seen a rapid transformation in access to health care news and information. When the Food and Drug Administration began to regulate communications around the marketing of pharmaceuticals in 1962, neither the FDA nor Congress could have predicted the evolution of our health care system or the information explosion we have seen in the past 20 years.

When Congress enacted the Food and Drug Administration Modernization Act of 1997, which created a pathway through Section 114 for pharmaceutical companies to proactively communicate health economic information with specific stakeholders, health care looked dramatically different than it does today. We did not yet have biologics or personalized medicine. We got our information through paper health care records, not real-time feedback from mobile health devices, searchable electronic health records, and other data sources. We have revolutionized how we treat many conditions, and who pays for medications now includes Medicare Part D, exchanges, and consumer directed health plans.

Given these changes, broader exchange and communication of how treatments work in the “real-world,” how they compare to alternatives, and their related impact on the total cost of care is needed. In fact, the ability to communicate valid, reliable information from many sources is critical to helping us achieve the common goal of delivering more efficient, high-quality health care.

Unfortunately, despite the best intentions of FDAMA Section 114, the exchange of information remains limited.

Ambiguities in the law’s language, coupled with a continued lack of guidance about its scope, have led to a lack of information exchange due to concerns from biopharmaceutical companies regarding the risk of penalties for violating standards.