The FDA is broken. What can be done?

Those hoping for a vaccine to be approved for kids 5 and younger are going to have to wait until June, if not later. The FDA is still dragging their feet, just as they have been on every vaccine and virus treatment they have looked at since the pandemic began. Moderna has submitted its data to the FDA and plans to formally request approval soon. There seems to be no doubt that it will be approved. Still, the FDA is in no rush.

I want to highlight two passages from the linked article to illustrate what is wrong with this picture. Some in the Biden Administration are not happy about what is going on. What Moderna has developed for those 5 and under is not being questioned in terms of its safety. The FDA is just sitting on their hands. Some of their reasoning is explained here:

Yet FDA officials have argued it’s a more complicated calculation. They worry that authorizing a single vaccine and then, soon thereafter, another one might make it harder for the administration to promote the shots and undermine confidence in their effectiveness.

A complicated calculation? Hardly. The vaccine from Moderna is safe and it should be approved, period. The FDA worrying about approving one vaccine after another being confusing and undermining confidence in their effectiveness is not science. The FDA is trying to play psychologist here. That is not their job. Their job is review medicine for its safety. If it satisfies their safety standards, then their duty is to approve it. All other considerations are irrelevant.

Whether what the FDA fears about confusion and confidence would even happen is hotly debatable. For parents who wish to vaccinate their 5 and younger kids, I can imagine most of them would be thrilled to be able to do it. They should have that option. There is no disputing the vaccine from Moderna is safe. It is infuriating and wrong what the FDA is doing.

Apparently, the FDA is also concerned that if they authorize the Moderna vaccine and the Pfizer vaccine turns out to be more effective, parents will be mad. Once again, the FDA is playing psychologist here. They are refusing to do their job because they think they know how others will think about vaccines. They have no way of knowing that and even if it was true it is not their purview.

Below is another quote from the article that exemplifies the biggest mistake the Biden Administration has made in its approach to the pandemic.

The White House has largely left the final decision to the FDA, wary of violating the “follow the science” pledge Biden made at the outset of his presidency. The White House referred questions for this story to the FDA.

Biden is making the opposite mistake of what Trump did. Trump disdained anyone with any expertise and treated them as if they were bad. That was a horrible approach. In his desire to not be Trump and to present himself as being driven by data and not emotion, Biden has gone in the opposite direction. He has deferred to the CDC and FDA at virtually every turn. There is plenty of middle ground between completely disdaining anyone with expertise and blindly deferring to everything they say no matter what.

The idea that pressuring the FDA to approve the Moderna vaccine now would violate his pledge to “follow the science” is beyond absurd. I really do not like that phrase and have written about that before. In this case, it is made all the worse because the FDA is clearly not following the science. On the contrary, they are ignoring the science that says the Moderna vaccine is safe because they are worried about how they think some people might react to the timing of their approval. Far from violating his pledge to “follow the science,” Biden forcing the FDA’s hand to approve the Moderna vaccine would be honoring it.

The FDA is not entitled any deference here. They have lost that right. They have dragged their feet on virtually everything from test kits to vaccines to antiviral pills. We were in an emergency for more than a year and the FDA kept operating like it was business as usual. I do not care what it takes, but Biden needs to bring down the hammer on the FDA. They are refusing to do their job and should be made to approve the vaccine that everyone agrees will be approved.

The good news is that those 5 and younger are the least vulnerable of any age group. They are even less vulnerable than those who are vaccinated and boosted. I am galaxies more worried about myself than I am about those 5 and younger and I am not worried about myself in the slightest. I would happily switch places with any of them.

The reason I want vaccines to be approved for those 5 and younger has nothing to do with them. It is for their parents to have peace of mind and to screw their heads back on. Despite their extremely low vulnerability, there are still parents who are insanely cautious and are denying their kids and themselves a social life. That is unnecessary and harmful, but it is still going on in some places. I would like to see that come to an end.

So far, as the linked article notes, a large majority of kids are unvaccinated. The number for those 5 and younger would probably be even lower. I think everyone should get vaccinated, but for kids I am much less concerned given how little vulnerability they have. Regardless of how many of those 5 and younger get vaccinated, parents should have that option. Right now, the FDA is depriving them of it for reasons having nothing to do with science.

What to do about the FDA going forward?

I think it is safe to say the FDA deserves an F for how they have handled the pandemic. The people running it have stuck to the same risk averse, slow, hypercautious approach they have taken for decades. It is time to revisit that model.

One thing that I think should be done is what is called “pharmaceutical reciprocity” or reciprocity for short. What it means is that any kind of medicine (or any item) that is approved by a trustworthy regulator similar to the FDA is automatically approved in the US. Trustworthy is the key word. Regulators would have to be from places with proven safety records, i.e., the UK, EU, Japan, Australia, etc., not North Korea or Afghanistan.

Allowing for reciprocity would mean many more drugs and other medicines would be available in the US than are available now. That would have come in handy late last year with test kits given that the FDA has not approved as many as the EU and UK have. Reciprocity would vastly expand the range of options people have and reduce the ability of existing businesses to use the FDA to keep away competing medicines.

There are two other measures besides reciprocity that I think should be looked at. One is for Congress to give the president the authority to override any decision by the FDA. The other is to give states the option to allow the use of unapproved medicine. Both of those would mark major departures from where we are today and could be much more sweeping than reciprocity.

I admit I have not given a ton of thought to either of those ideas, which is why I am saying they should be looked at and not acted on immediately. Both could do very good things, but also come with major risks. I have never heard anyone advocate for either of those ideas. I am not claiming to be the first one to think of them and am sure someone somewhere has suggested one or both of them, but I have never heard anyone do that.

In the case of the president overriding the FDA, there is a risk, for example, of a donor to their campaign pushing them to approve a drug that is not necessarily safe. That would, obviously, be a bad outcome, but the good news is at least there would be the option to hold accountable the person who made that decision. If a president overrode the FDA and the drug approved turned out to be dangerous, it would be on them and if they were in their first term it would probably be their only term. If it was found out they did it for a donor, that would be a huge scandal and hopefully would be the end of their presidency.

Regardless of what is done should such a situation arise, there would be the option of democratic accountability. The president and Congress are accountable to voters. The FDA is not. The people there wield immense power over who can have access to medicine, but do not have to worry about the fallout from any of their decisions, especially when they do not approve something. Sometimes that can be a good thing, but other times it can be very costly. I would argue that we are erring too much on the side of caution while not really achieving improvements in safety. While there can be a tension between safety and a quicker approval process, it is a needle that can be threaded and that is not what is happening right now.

Like I said, I am not endorsing that idea, at least not yet. It could have very far-reaching consequences and that is something that should be thought through before adopting it. Still, it is something that is very much worth at least taking a hard look at.

The same is true for allowing states to opt out of FDA regulations. There is a risk that a state could allow its residents to take an unauthorized medicine and people could get sick from and maybe die. Like with the president, a governor or legislator(s) could be pressured by a donor(s) to allow unauthorized drugs in their state even if they are not safe. Conversely, it may be that a drug is safe and the FDA is too cautious. If some states allow it to be used and it is proven effective, then other states will follow suit and maybe the drug will be available nationwide when it otherwise would not have been. Those are things that need to be taken into account before such an idea is adopted. Like the president overriding the FDA, allowing states to opt out of FDA regulations is something that should at least be looked at.

What should be clear is that the FDA right now leaves so much to be desired. Their culture is sclerotic and risk averse to an obscene degree and will not change by itself. While the more drastic steps I mentioned should be thought through carefully before being implemented, if ever implemented, reciprocity is a no-brainer. It will require an act of Congress to get done. Congress should do that right now.

What are the odds any changes will happen?

Unfortunately, slim to none. As much as I wish otherwise, there is no major push by anyone to change how medicine is approved in the US. Some economists and pundits have talked about the need for it, but that is basically it. While some elected officials may complain about the FDA from time to time, few seem to be willing to actually do anything about it. As for public opinion, I have never seen any large protests where people were shouting, “What do we want? To fix of the FDA approval process! When do we want it? Now!”

There is no popular demand for changing anything at the FDA or any government agency for that matter. I would be surprised if even half of Americans know what the FDA is. As bad as the FDA has been, civilization has hardly been destroyed. Yes, we could be doing much better on so many fronts, but we are hardly living in a dystopian nightmare. If someone running for office did push for changes at the FDA, I do not think it would hurt their election chances, but I doubt it would help either. It is just not an issue many people ever think about, let alone vote on.

Ultimately, most people are relatively content in their own lives. Most people spend almost no time thinking about politics, let alone policy. To the extent they ever do, it is general and abstract, not specific and concrete. Status quo bias is very strong and hard to overcome. Our political system with its many veto points makes change even harder on top of all that.

For any real change to happen with the FDA, there would have to be some kind of massive crisis that they were standing in the way of solving and I cannot even fathom what that would look like. As harmful as the FDA has been, a vast majority of people have not been hurt by it, at least not directly. If they have been harmed, there has likely been so many degrees of separation that few of them would connect the dots. I am not saying people are stupid. What I am saying is that people for the most part are focused on their own lives, do not follow politics or policy and are averse to change. They are not going to demand significant changes to anything absent something very disruptive happening to them or someone they care about.

I would love to be wrong about all this. There are so many areas where policy changes would improve people’s lives materially. Still, as much as there are many changes that we badly need, we are hardly living in a hellhole. We have been through a whole lot in the last twenty years and are still here. The financial crisis and the pandemic were huge events that did a lot of damage, but civilization is still very much intact and the vast majority of people are doing well enough. We should be grateful for that, but the flip side is that it makes the push for all kinds of needed changes much more difficult. Such is the paradox of success.