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The Demonstration of Accountability to Multiple Stakeholders

January 8, 2016 defines “accountability” as:

The obligation of an individual or organization to account for its activities, accept responsibility for them, and to disclose the results in a transparent manner. It also includes the responsibility for money or other entrusted property.

As taxpayers and voters, we expect government in general to be accountable to us for the funds and authority that we give it. As advocates for a very specific agency within the federal government, we recognize that organizational accountability is critical to the success of the FDA’s public health and regulatory functions, as well as essential to any claim that FDA needs additional funding.

Accountability is not a pass/fail process. Rather, the quality and success of agency accountability can vary by activity, such that FDA might get an A for its advisory committee process (extraordinarily public and transparent) and maybe a C for its hiring processes, which are widely viewed as struggling. Looking at some relatively recent FDA efforts to increase accountability, I think of the patient-engagement initiatives, release of strategic plans and progress reports by the Centers, the 2015 Science Board evaluation, and the continued involvement of the Office of Chief Scientist in driving regulatory science initiatives.

One FDA effort of particular note is FDA-TRACK, a series of performance measures and activities indices that criss-cross every part of FDA. The goal of the program is in its name: Transparency-Results-Accountability-Credibility-Knowledge Sharing. FDA was one of the first federal agencies to adopt this program that has its roots in state government accountability efforts. Accordingly, there is still a learning curve about how to make sure it is an effective tool for driving and measuring performance and increasing meaningful accountability at the federal level. An important goal is to make accountability a priority even in programs that would otherwise be far removed from the oversight of FDA senior leadership.

Accountability matters. Without it, we cannot know whether FDA is achieving its broad organizational responsibilities for safe and effective medicines and a safe food supply. Nor, without accountability, can we be sure that FDA is achieving its myriad other vital responsibilities in homeland security, radiation health, cosmetics, animal health, infant formula, etc.

As advocates for funding for FDA, the agency’s accountability plays a special role in our efforts. If the public, media, and, of course, Congress are not satisfied that FDA is a high-achieving agency and a good steward of its public funding, then our prospects for future increases are greatly diminished. The most immediate form is the question we are asked all the time in Hill meetings: What did FDA do with last year’s monies and why can’t they perform the same services for less? While there is a long answer that takes many forms (the heart of our advocacy arguments), the simple response is that FDA responsibilities grow each year because of innovation, globalization, and increased scientific complexity. Most years there are also new legislative authorities to implement, such as food safety modernization and drug quality and security.

Overall, we believe that FDA is an effective public health and regulatory agency that produces far more value for the public than it costs. But, as noted, accountability is not pass/fail and the agency will always have some areas for which it needs to be more accountable.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.

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