Formula Shortage? Federal Failure

Posted on Monday, May 16, 2022
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by AMAC, Robert B. Charles
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FDA formula shortage

The Food and Drug Administration (FDA) has broad authority, big budgets, experts, and a mission that matters. A big part of their mission is food safety – for health and national security. The current baby formula crisis, a shortage driven by contamination and slow FDA action, is a warning: the FDA is behind the curve and must be proactive. Ditto for the entire federal government.  

Recent investigations suggest the FDA is – like much of the federal government – in that “good enough” mindset. Only “good enough” is not good enough. Across government, “good enough” leads to policy, program, budget, and mission failures. This is not a secret and it’s not getting better.

Having once been Chief Counsel to the U.S. House Oversight Committee’s investigative subcommittee focused on Defense, State, Justice, and NASA, my perspective is shaped by what is possible – not what passes for acceptable, not what is okay because it’s not criminal.

Taxpayer accountability is what is missing. As with oversight of baby formula supply – which now appears to have been inadequate, untimely, inconsistent, and slow to resolve – other parts of government are missing the mark.

At State, “withdrawal preparations” out of Afghanistan were “good enough,” deterrence of Russia’s invasion into Ukraine was “good enough.” At Defense, morale, readiness, and ballistic missile protection are – somewhat frighteningly – “good enough,” despite hypersonic missiles.

Closer to home, in one year, the Government Accountability Office (GAO) just added seven new “high risk areas,” where things have gotten measurably worse – on top of those already sliding. Thus, new urgency is attached to cybersecurity, the Post Office, the Environmental Protection Agency (EPA), Census, and Human Capital Management (across government), plus Health and Human Services and prison management.

These weaknesses come on top of unresolved high-risk issues at 38 other federal departments, bureaus, and agencies, from Defense, small business, surface transportation, information technology, energy sector management and Veterans’ care to the multi-agency failure in stopping exponential growth in drug abuse, addiction and overdoes (diffuse responsibility, finger pointing, loose accountability, low priority). 

So, stepping back 20 paces, what we are seeing nationwide on baby formula shortages, based on a major missed cue last September, slow response, and a boatload of excuses – is not uncommon. High risk areas exist across the government, and of course the missing pieces are leadership and accountability.

So, what exactly is wrong at the FDA? And then, more broadly, how do you fix erosion of leadership and accountability? At the FDA, the issues are several and well known, just ask the non-partisan GAO. The FDA needs “leadership commitment” for starters, as “federal agencies have not developed a national plan or strategy for food safety” and “Congress has not directed the Office of Management and Budget (OMB) to develop a government-wide performance plan for food safety.”

Of course, having a plan and directing it to exist is just a start – it then must be responsibly, swiftly, and effectively implemented. What else does the GAO show missing at the FDA? Lots, such as internal capacity, action plans, program monitoring, and seriousness of remedies.

The GAO says bluntly: “The safety and quality of the U.S. food supply, both domestic and imported, are governed by a highly complex system stemming from at least 30 federal laws that are collectively administered by 15 federal agencies” and “we have long reported on the fragmented federal food safety oversight system, which has caused inconsistent oversight, ineffective coordination, and inefficient use of resources.” Boom, tick.

What does all this mean? At the FDA, it should mean get yourself in gear and move out. Is it better to nurse a baby formula crisis or prevent it? Is it better to get ahead of domestic or foreign supply contamination – let alone intentional contamination – or wait?

Obviously, since we have the ability, the goal should be 100 percent food safety. Is that not what tax dollars are for? If we cannot all run a farm, we should have an FDA that runs food safety.  

You reverse poor leadership with good leaders. You assure accountability by demanding it – having Congress demand it, doing real oversight, not playing political games, and then rallying citizens to demand accountability.

In the end, the baby formula debacle was preventable – and by whom? Biden’s FDA and a Congress doing their job, namely, hands-on, real-world, and proactive government oversight.

Net-net, the shortage we face may be less about baby formula than national leadership, federal accountability, and congressional oversight…But for now, let’s just hope the FDA can end this unnecessary crisis and get the bottle back to half full or better. “Good enough” is not good enough.

URL : https://amac.us/newsline/national-security/formula-shortage-federal-failure/