Promote vs. Protect – For almost 100 years the FDA mission was to protect, from the "snake oil" salesmen in the early days, to today's modern science and technology across international commerce. It is only in the last decade that the term "promote health" was formerly added to the mission.
In 1848 the idea of the FDA was born with the appointment of Lewis Caleb Beck in the Patent Office to carry out chemical analyses of agricultural products. To put into context, Texas and Florida were still becoming states and the California Gold Rush had not yet happened. "Snake oil" salesmen sold products to consumers until they were run out of town, and yet continued to stay in business by simply staying ahead of their reputations. More Clint Eastwood's "Unforgiven" and Wayne's "The Searchers" than the happier "Red River."
After a quarter-century in the making, the 1906 Pure Food and Drugs Act put into law regulatory functions that prohibited interstate commerce in adulterated and misbranded food and drugs, providing basic elements of protection that consumers had never known before that time. This point has never made it into the westerns, but by 1930, the oldest comprehensive consumer protection agency in the Federal Government was formally named Food and Drug Administration. You can imagine the early 1900's public health officers were like sheriffs protecting citizens.
Though intuitively to "promote" health has been a value held for decades by individuals working at FDA, the recent explicit focus on "to promote health" is a fundamental change to the culture of the organization, and thus processes are changing.
At FDA's Center for Devices and Radiological Health, new guidelines such as Benefit-Risk Determination in Medical Device classification are emphasizing the dynamic factors FDA must consider for approvals. No longer is it sufficient to simply evaluate risks. Now Patient Benefits must be taken into consideration as a tradeoff.
Thus a device with higher risks, which in the past may not have received approval because of its risk despite the relief to patients, may now be considered. In the drive towards patient centered health care, adding patient Benefits is ideal, right?
Yes, but conditionally yes. Any opposing consideration brings complexity and uncertainty. To address this uncertainty, industry is moving to understand how to assess Benefit relative to Risk, by leveraging computer analytics to digest the right data sets and enable intelligent decisions.
Tools such as ClearRoadmap's Benefit & Risk Analysis are designed to aid with this sort of decision making process. In essence, it is the old "Measure Twice, Cut Once" paradigm of craftsmanship brought to medical processes.
-- Vizma Carver, Founder and CEO, Carver Global Health Group