Outdated Regulatory Framework Hinders Exchange of Information in Healthcare System

We Must Utilize Accurate and Data-Driven Information to Achieve Best Possible Patient Outcomes

01.28.14 | By Stephanie Fischer

Before the holidays, PhRMA’s General Counsel Mit Spears wrote a post in The Catalyst about the need for a new regulatory paradigm to govern how the biopharmaceutical industry communicates with healthcare professionals about the medicines that our companies research and develop.

This is a topic you will see more regularly on the Catalyst as we consider the importance of the exchange of information within the healthcare system and how our current outdated regulatory framework is hindering this dialogue, to the detriment of patient care.

Biopharmaceutical companies have the most in-depth, sophisticated information about the medicines they make, including healthcare economic information.  The ability of biopharmaceutical companies to proactively share this information with payers, formulary committees, and similar entities can benefit formulary decisions, ensuring that they reflect the full body of evidence regarding the most effective and economical treatments for specific conditions.

Unfortunately, just as companies are restricted in what information they communicate about medically-accepted, alternative uses of medicines with healthcare professionals, they are also restricted from proactively disseminating healthcare economic data even to limited audiences such as payers and formularies.

These restrictions exist despite provisions of the Food and Drug Administration Modernization Act (FDAMA) which was signed into law in 1997.  When crafting the legislation, Congress specifically recognized the value of allowing biopharmaceutical companies to proactively disseminate economic claims backed by “competent and reliable scientific evidence” to sophisticated health care stakeholders.

Unfortunately, FDA has neglected to issue formal guidance about this provision (known as FDAMA 114) in the intervening 16 years.  Without this guidance, companies are reluctant to share the growing wealth of economic information to discrete sectors of the healthcare ecosystem out of legitimate fear that they could face harsh penalties under the current regulatory environment.

As Mit said in his blogpost, information is a critical tool. As the healthcare system continues to grow ever more complex – which it is sure to do – we must utilize accurate and data-driven information to achieve the best possible outcomes for patients.


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