Behold: The Incredible Breadth, Depth, and Complexity of FDA’s Responsibilities
For much of the past 20 years, my primary professional responsibility has been to impress upon lawmakers, the media, and stakeholders that FDA’s value far exceeds its budget.
Sometimes, I would emphasize the economics — FDA oversees goods and services that total nearly $4 trillion per year globally. The US component amounts to about 20% of all consumer spending.
At other times, I would emphasize the history — the FDA was created in response to the dramatic failure of caveat emptor, which resulted in unsafe foods and medicines being a common and constant risk.
Sometimes, I would emphasize the complexity of the FDA’s mission. The Social Security Administration manages trillions of dollars but has only six or seven program activities that are repeated millions of times. In contrast, the FDA has hundreds, if not thousands, of program activities that require separate attention because they do not duplicate each other.
At other times, I would emphasize the global reach and responsibilities of the agency. FDA-regulated products are manufactured or handled at nearly 300,000 registered facilities. More than half of those facilities are located outside the U.S.
Regardless of my approach, I would always emphasize that FDA’s dedicated and diligent staff are the key to the agency’s success in managing this incredible breadth, depth, and complexity of responsibilities. It is crucial to recognize that FDA’s responsibilities are core functions of government. Accordingly, consumers are at risk whenever FDA lacks the necessary funding, workforce, and leadership.
With that perspective, I appreciate Dr. Makary’s efforts to build up staff and find more efficient ways to fulfill the agency’s responsibilities. Even still, I am troubled by how many FDA initiatives start with labor-saving conclusions rather than labor-expanding questions. In the past, FDA has always seen the wisdom of public input, especially consultation with outside experts through advisory committees chosen for balance and breadth of view. We need that back ASAP.
My most widely reprinted column, “ All of Us Need to be Rooting for FDA,” expresses a sentiment that not everyone shares. However, it may read differently to many in light of this week’s multiple resignations among CDC’s leadership (covered by MedPage Today here). Regardless of any disagreements we may have with current FDA policies and leadership, we must prioritize stability and continuity for the FDA to continue serving the American people effectively.
My role, through FDA Matters, is an extension of what I have done for several decades: perform policy analyses of issues facing FDA and advocate for positions that help the agency fulfill its responsibilities.
I hold the current administration to the same standards that I have applied to its predecessors in the past. That will never change because FDA’s incredible breadth, depth, and complexity require constant attention.
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