Biden Administration

Can the FDA's New Commissioner Save the Agency From Itself?

Robert Califf must demand transparency and accountability from the bureaucrats.

|

Public trust in the U.S Food and Drug Administration (FDA) is at an all-time low, largely due to its bumbled handling of the pandemic. But its failures in tracking, testing, and combating COVID-19 reflect decades of dysfunction at the agency. The incoming commissioner, Robert Califf, has an opportunity to pull the agency out of its fiery tailspin—but only if he is willing to confront an institutional culture of perverse incentives.

In a better world, the FDA would be single-mindedly focused on protecting public health. The agency's performance would be measured by its effectiveness in achieving that goal, and its employees would seek out the best data to achieve it. Instead, the strongest incentives are to boost the bureaucracy's reputation, budget, and scope of authority—which aren't quite the same as public health gains.

Perverse Incentives

In his recent book Fixing Food, Richard A. Williams gives us a sobering glimpse at how those incentives undermine the FDA's stated mission. His account is rooted in personal experience: He worked at the FDA for nearly 30 years performing cost-benefit analyses on proposed regulations.

These analyses were ostensibly meant to help decision makers choose a course of action to maximize the public health benefit at the lowest cost to society. But as he quickly learned, delivering actual benefits to the public is not a high priority among much of the agency's leadership.

One of Williams' first assignments involved a proposed ban on an ingredient in men's hair dye that was suspected of raising skin cancer risk. After researching the issue, he determined that the ingredient was unlikely to give anyone cancer and that, because there was no alternative ingredient, the costs of banning it would be high. Rather than simply accept this assessment, a higher-up at the Center for Food Safety and Applied Nutrition (CFSAN), where Williams worked, instructed him to redo the analysis because "they haven't decided whether to ban that stuff yet, so they need one that supports a ban and one that doesn't."

Williams thought changing an analysis to reach a predetermined conclusion was tantamount to "economic prostitution." But when he refused, the center's deputy director threatened to fire him.

Faced with the threat of termination, it would be hard for even highly principled employees to disobey a superior's order, even if it violates his personal sense of ethics. (And sure enough, Williams folded.) But more often than not, employees develop an implicit understanding of what their workplace rewards, what it punishes, and how to behave in order to protect their livelihoods and advance their careers.

For example, after Williams conveyed his assessment that banning the hair dye ingredient in question would not protect anyone from cancer to his direct supervisor, his supervisor reportedly responded that protecting people was not the point, saying: "It's not necessary for us to actually protect anyone with a regulation. What we're trying to do is to stop people from attacking us." And to do that, they "have to appear to be doing something." On the bright side, "no one ever checks to see whether or not what we did actually did anything."

That pretty much sums up the work culture's incentive structure and its hazards.

Were this isolated to one rule, manager, or administration, it could be shrugged off as an outlier. But as Williams' account and other sources indicate, this type of thinking is common precisely because the same incentives operate throughout the FDA's chain of command. "Success" for FDA bureaucrats depends on how their actions help or hurt the agency's image among the politicians that approve its funding, the media that covers its activities, the industries it regulates, and the public, regardless of the effectiveness of any given policy or of the agency overall. This focus on appearances over results reflects the influence of politics.

Like all federal agencies, the FDA is inherently political. As part of the executive branch, it answers to the president, who nominates commissioners and recommends funding levels, and to Congress, which confirms commissioners and approves agency budgets. Should an agency do something that angers people in either branch, such as issuing rules they dislike or refusing to take action politicians desire, agency officials may find themselves harangued at congressional hearings, on the receiving end of inquiries, forced to resign, or facing budget cuts.

In theory, this oversight gives elected officials a way to hold unelected agency bureaucrats accountable, ensuring they stick to their mandate, enforce duly enacted laws, and deliver the public service they were established to provide. In practice, politicians mostly care about holding agencies accountable when they believe doing so advances their own political interests. And as with the perverse incentives for FDA employees, legislators see little benefit in holding agencies accountable for actual results.

How To Fix It

Restricted by statute, presidential executive orders, and absent congressional intervention, a single FDA commissioner is limited in the reforms he or she can unilaterally institute. But there is much a commissioner can do to set the stage for reform and long-lasting cultural change by changing the incentives that govern both bureaucratic and political behavior.

If the biggest problem is regulators' and political overseers' lack of interest in the effects of regulations, one solution could be to make agencies justify the regulations they promulgate. As Williams' anecdote suggests, such rules already exist—on paper. Since President Richard Nixon, both Democratic and Republican administrations have put forth requirements that agencies justify regulations to some degree. But without a way to verify the assumptions agencies use in their analyses or a way to hold them accountable after the fact, these cost-benefit analyses become little more than a meaningless exercise.

Beginning with President Ronald Reagan, the Office of Information and Regulatory Affairs (OIRA) within the executive Office of Management and Budget has been responsible for reviewing agency cost-benefit analyses. OIRA, with about 45 employees, is responsible for reviewing every major rule issued by agencies and can block rules that fail to comply with economic executive orders or a presidential administration's agenda.

Agencies use several methods to get around OIRA. One is to include superfluous requirements in a rule, which lets OIRA look like it is doing its job by eliminating those unnecessary requirements while preserving the parts the agency wanted in the first place. But in Williams' words, "the most common way to control OIRA is to lie to them"—or, more specifically, to fudge the numbers agencies use when producing cost-benefit analyses.

For example, in the early 1990s, after Williams had risen to the position of chief of CFSAN's economics branch, he was tasked with analyzing the costs and benefits of a proposal that would institute sweeping new requirements on seafood processors with the goal of reducing food-borne illnesses. The most dangerous of these illnesses was contamination from Vibrio vulnificus, a type of flesh-eating bacteria transmitted primarily by eating raw oysters, particularly those from the warm waters of the Gulf of Mexico. But the rule did not actually address the problem of raw oysters. So Williams found that its cost would be devastating for small seafood businesses (though not the large producers who had already voluntarily adopted the standards) and outweighed the benefits.

But the rule was a priority for the FDA commissioner, who wanted to beat the Department of Agriculture at claiming regulatory jurisdiction over seafood—and the budget that goes with it. So again, Williams was told to change his analysis. In fact, he was given the exact numbers he was to use to calculate the rule's "benefits." According to Williams, he was told to say that "it will prevent about fifty percent of the cases from occurring."

Again, Williams was told that if he refused to fudge the numbers, he "shouldn't come back to work on Monday."

Williams was forced to falsify an analysis to produce a result supportive of a predetermined decision made by higher ups. For all of this, Williams was given the highest award the agency offered its employees. Upon receiving that award, he was told that it "isn't for anything you've done, Williams; this is for what you will do!"

Fourteen years after leaving the FDA, Williams looked into seafood-related illnesses to see how the rule had performed. He found that cases of Vibrio vulnificus had not halved, as the agency had predicted; they had doubled.

The costs of this fell entirely on consumers and small businesses, while no one at the agency paid for its mistake: not the economists forced to produce erroneous cost and benefit estimates, not their bosses who compelled them to make analyses supporting a predetermined policy agenda, not the commissioner who set that agenda, and not the politicians supposedly responsible for holding agencies accountable.

Without any real negative consequences, this sort of malfeasance has grown worse. Politics and the focus on appearances have left agencies like the FDA unprepared to actually protect the public when it counts, like during a dangerous viral pandemic.

What can an FDA commissioner do to alter incentives both within the agency and for those overseeing its activities, even while constrained by the job's parameters and its political nature?

One step would be to uphold higher standards of conduct, such as rewarding employees for their commitment to the agency's public service mission and punishing those who prioritize politics. Another is to strengthen the agency's focus on results and punish falsification of data, even when doing so would support desired policy outcomes. Yet another is to boost transparency, giving greater freedom for agency scientists to speak with the media and the public (the FDA currently holds a "C" grade on scientific transparency from the Union of Concerned Scientists) and protecting whistleblowers who call out unethical behavior.

Perhaps the most important thing a commissioner can do is to bring public attention to the FDA's shortcomings and work with lawmakers to institute reforms, rather than looking for ways to protect its institutional reputation. Publicizing the FDA's flaws and failures may harm its chief's political standing and risk diminishing the agency's budget or authority, but it may be the only way to create real outside oversight.

Given his stellar reputation as a scientist, his commitment to transparency, and the mistakes he made in his last stint as commissioner, one can only hope that Robert Califf will set politics aside and do what is needed to save the FDA.

NEXT: Brickbat: Red-Carded

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  1. In a better world, the FDA would be single-mindedly focused on protecting public health.

    In a better world, the FDA wouldn't exist. Single-mindedly focused on protecting public health is what we got in 2019-2021 (and before). Focused to the point that they don't care how many lives they destroy in the process.

    1. FDA stands for FEDERAL DUMB ASSES. Like most federal travesties, it pisses away tons of citizens' money while producing nonthing good. The FDA should be dumped like the trash it is.

      1. But how are you going to do that, given the broad and longstanding public support for its existence, not only in the USA, but its equivalent in every other country? People all over the world, via their legislatures, have demanded a boss agency with this type of power. So what can be done to placate them while mitigating their impact?

        1. There is ZERO public desire for the FDA, just as there was zero desire for a federal government , as most issues are at the state or local livell,which the feds have zero knowledge about.

    2. Absolutely. The proper fix is to delete the FDA, root and branch. Leave the field to independent private agencies: consumer-focused ones will test and certify on their own, surviving off consumer donations; industry agencies will survive on certification fees; and some corporate shills will be funded directly by businesses, with little public trust.

      Then this guy wouldn't have to worry about being fired for not lying; he'd be a whistleblower hired by some other agency.

      1. So how do we get that? Are there any countries in which that reform has been achieved when it came to foods and drugs or with any other product or service that used to have a government boss agency for it?

        Take the example given in the article: FDA adopts procedures and standards for shellfish to cut the incidence of poisonings, and they double instead. How do we convince voters or the legislators who represent them to get government off the job entirely, when I'm sure their impulse would instead be to do something to make government do the job better? The fix to government doing a job badly usually seems to be to get a czar to oversee whoever's been in charge, and then when the czar doesn't fix it, to get a super-czar over the czars, etc. Because low trust leads to more untrustworthies being given authority.

        1. Where and when was the last revolution? If there's not politicians adorning lampposts, it probably wasn't thorough enough.

  2. No.

  3. #defundFDA

    1. Upon reflection,
      #defundall3letterfederalagencies.

      (makes for a long bumper sticker, doesn't it?)

  4. Beside protecting whistle blowers, I'm not sure how any of these proposals could be realistically implemented. The corruption came from the top for decades. Switching leadership priorities now sent change the fact that the people who were promoted for this entire time were the people willing to go along with the corruption. Rot like that would take decades to fix, and a non corrupt leadership can't be guaranteed for decades.

    1. Fire them all. If you are in a leadership position in the FDA, you have been corrupted.

      1. I've wondered sometimes if it is possible to perform a mass firing like that, or if the public unions have extracted protections that make it impossible.

        1. Unions need to go first. They are a huge part of why we can't fire bad gov't employees and cops.

    2. Corruption is inherent in coercive monopolies.

  5. No he can't, and he is NOT new to this position. He served in the same role under Obama. Wonder why that was left out of this article.

    1. Thank you, repeaters have short memories.

    2. Obviously because everyone at Reason hates Trump and voted for Biden.

      1. And you're totally not a lefty.

        1. I'm about as lefty as you are intelligent, witty, charming, and likable.

          1. Why, thank you. I blush.

            1. Thought you'd be embarrassed. I've got a suggestion. Rather than be a troll who I mute forever (unless your goal is to be cool like the people I never respond to because I don't bother to read their garbage) why don't you respond to what I actually say. Or keep being a dick and I'll stop wasting my time.

      2. POST THE LIST.

        It's hilarious to see the grand threadshitters crying because nobody takes you seriously and hasn't forgotten your lefty shilling for the past few years.

        "Obviously because everyone at Reason hates Trump and voted for Biden."

        Deep thoughts there, SQRLcasmic. What did Jimmy and Jack think about your cutting wit?

    3. Seriously? (Checks Wikipedia). Jesus fucking Christ Reason, this is journalism 101 type shit. Pathetic.

    4. Actually it’s sort of stated in the last paragraph with the link.

    5. It wasn't left out (see the last paragraph)

      1. But the article was so much about Richard Williams that I forgot all about Robert Califf. Seriously.

  6. Can a former insider bring a breath of fresh air and transparancy to a crooked federal agency?

    No. It's not gonna fucking happen.

    If you want to reform XYZ agency, make it easier to fire government employees to start. Disband unions next and then you can maybe institute some actual ethics policies.

    1. But it was the threat of firing hi that corrupted him, so how is making that easier going to improve things?

      1. And his appropriate response SHOULD have been to document the interaction, refuse to perform unethical actions and blow the whistle on his boss.

        The wrong response was to be corrupt, then cry about it years later.

        1. Amen! Except ...
          * What kind of whistleblower protections existed at the time?
          * It would require every single employee to have the guts to buck the system, and the resources to wait years to collect back pay while shelling out for lawyers.

          1. Sad but true. Unsure about protections, but I think we need incentives for whistleblowers - reveal corruption and get a bonus. Save the government money and get a percentage.

            Lots of resignations and squeaky clean books.

            ...and never gonna happen.

    2. Sadly, the swamp appears to be full of alligators that will vigorously resist any attempts at drainage installation.

      1. You in the market for some new boots?

  7. How was he able to publicize his adverse experience and still get appointed commissioner?

    1. The person who wrote the book isn't the person who is taking over the FDA, which, yes, I also found the text not exceedingly clear on who was being spoken of. I had to go back and check in the middle. It's because we get the headline question of the article, and then the article basically just doesn't even mention him until the end, past the first two paragraphs.

      1. Yes, on clicking back onto the article a few hours later I saw the name in the subhead and asked myself, "Who's Robert Califf and how'd HE get in there?" So really his reappointment was just a news hook for someone to write about Williams's book, which Michelle Minton happened to have read some time previously.

  8. Symptom:

    ,Instead, the strongest incentives are to boost the bureaucracy's reputation, budget, and scope of authority—which aren't quite the same as public health gains."

    Problem:

    CONgress ( emphasis on ' con" ) Ignored the Constitution in which the People ONLY authorized Three Govt entities and invented its own.

    They are unaccountable. CON gress and the Agencies.

    No one gets fired for failure.

    No one goes to jail for corruption.

    Odd that our legal system basically only levies penalties against Citizens.

    This problem became orders of magnitude worse when the Income Tax was created, fueling this money gobbling monster.

    Its created a top down, irresponsible, unaccountable, Statist, Authoritarian system ....

    rather like what Pres Reagan described in his 1983 speech about evil Russia. The Evil Empire speech exactly describes what Russia are doing in Ukraine right now.

    Just coinky- dink, Im sure. The evil cant be us..

    And we have a President now going to address Saudi Arabia and hes too senile to address a letter.

    "Were boned." Bender

    1. +

  9. Great read; two take aways that seem to sum up the entire history of all governments:

    1. "Faced with the threat of termination, it would be hard for even highly principled employees to disobey a superior's order, even if it violates his personal sense of ethics. (And sure enough, Williams folded.)"

    2. "It's not necessary for us to actually protect anyone with a regulation. What we're trying to do is to stop people from attacking us." And to do that, they "have to appear to be doing something." On the bright side, "no one ever checks to see whether or not what we did actually did anything."

    And there you have it; all of bureaucracy in two statements.

  10. Williams thought changing an analysis to reach a predetermined conclusion was tantamount to "economic prostitution."

    Heh, 'economic prostitutes'. "When they're dead, they're just hookers."

  11. The question BEFORE this one is -- was he hired to save the agency or simply to continue its decent?

  12. is he going to fire everyone and send back the money then quit?

  13. Williams was forced to falsify an analysis to produce a result supportive of a predetermined decision made by higher ups.

    He wasn't forced. He could have said no. He could have threatened to go to the press. He could have gone to the Justice Department.
    He probably could have gone to GAO. He could have pissed on his manager's desk.

    1. Exactly, this is called dump and run or in this case run and then dump. It’s like all those actresses who said nothing about Harvey Weinstein when he could affect their careers but once he was out suddenly they found their bravery, allowing many more women to be molested in the meantime. This guy allowed thousands of people’s lives to be ruined and or ended by disease knowing the regulations his reports backed would be or were responsible. Not only should the administrators be held responsible he should as well.

      1. Yes. Both situations are infuriating for me - how do people stand by and let this happen right in front of them when they can do something?

  14. How about a Reason article on the Drug Czar (Sultan? Raja?) Biden imported from India?

  15. How to fix it

    Ooooh, oh I know! Disband the agency entirely and rescind every regulation it was enforcing? Is that the answer you're looking for? Because that's the answer.

    1. I dunno, not enough woodchipper in it... Someone might have ideas about doing it again.

  16. You don't mention the most perverse incentive of all: since the FDA is a government agency, it *has* to screw up occasionally to maintain and increase its power and funding.

    When a Darvon or Quaalude event occurs, the FDA tells its funders in Congress, "This is what happens when you don't give us enough money and enough power and enough people." And Congress, which never passes up an opportunity to spend more money, especially to 'protect' the public, happily goes along.

  17. Doubt it. Califf is revolving door from Obama admin and govt resistance to publishing Pfizer docs is terrifying.

Please to post comments

Comments are closed.