As the weather turns warmer and you’re looking for some beach reading, may I recommend FDA’s, “Strategic Priorities 2011-2015: Responding to the Public Health Challenges of the 21st Century.”
And therein the first issue. If the FDA views it’s job as only responding to challenges, which needs to change. The FDA needs to be a change agent – to drive change.
As the bard said, “Action is eloquence.”
The good news is that, under “Vision,” the report reads as follows:
FDA is dedicated to world-class excellence as a science-based regulatory agency with a public health mission. We aim to provide effective and innovative leadership — both domestically and internationally — to protect health, prevent illness, prolong life, and promote wellness.
Leadership. Crucial. Both domestic and international. Absolutely.
There are many crucial initiatives (and I am pleased to report that advancing regulatory science is given a lot of ink). But since we are dealing with the future here, the report is lacking in, what we might call, PDUFAbulousness.
Here’s what the report says about “accountability” —
Consistent with our strong commitment to public service, we will maintain the highest degree of individual and professional accountability in the quality and ethical conduct of our work. Currently, we set measurable goals and openly monitor performance within the agency to make sure we continue to meet our commitments. We hold staff members and executives accountable for achieving organizational goals through annual performance plans that are aligned with our strategic priorities. And we monitor program performance by holding quarterly meetings with program managers and agency executives and sharing program performance data with the public through a new initiative called FDA-TRACK. We understand the importance of FDA’s work to the health and welfare of our nation, and we will continue to hold ourselves accountable for delivering on the responsibility.
Hurrah. But one must add, “Yes, but additional Congressional oversight might help too.
There seems to be an inability (or a desire?) to openly discuss the importance and urgency of collaboration with industry. Consider this segment under the header, “Innovation/Collaboration” –
We have gained substantial knowledge through more than 100 years of building regulatory programs to ensure the safety and integrity of foods, medical products, and cosmetics. But we also recognize that the promises of science and technology require us to seek new approaches to performing our mission, particularly because competition for scarce public resources makes it difficult to simply scale-up past solutions to meet rising demands. By investing in the field of regulatory science, FDA is fostering innovations that we hope will enhance our effectiveness and productivity for years to come.
We cannot achieve our vision and address the challenges of the 21st century by working alone. To make rapid and efficient improvements in public health and drive innovation, we must harness the best ideas from a broad range of stakeholders and leverage resources through collaboration with other federal, state, and local regulatory and public health agencies; non-government organizations; consumer and patient organizations; academic medical centers and research universities; the private sector; and the public. For example, FDA is collaborating with state and local food safety authorities to develop standards and training that will establish a more integrated and coordinated national food safety system.
The Critical Path Initiative (CPI), an agency effort to modernize the sciences for developing, evaluating, manufacturing, and using FDA-regulated products, has long recognized the importance of collaboration to leverage critical expertise and resources in driving scientific innovation. Building on CPI, FDA’s Advancing Regulatory Science Initiative recently established a formal collaboration with the National Institutes of Health to advance regulatory science and build the capacity needed to ensure the safety and effectiveness of innovative new products and technologies.
One assumes that by “the private sector” the agency means “regulated industry.” So why don’t they say so? Why the need for code language. At the end of the day, if you can’t say it, you won’t do it. This is particularly disturbing relative to the Critical Path Initiative. And here’s a question – why do the words “Reagan/Udall not appear anywhere in the report?
The full report can be found here.
And enjoy the read.