FDA is slowing down production of hand sanitizers

FDA is slowing down production of hand sanitizers
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We’re all doing everything we can in a tough situation, but the Food and Drug Administration (FDA) – my former employer – isn’t making that easy. In addition to stopping at-home coronavirus tests and insisting on efficacy trials for potential COVID-19 therapies that have already been proven safe, it is now slowing the production of hand sanitizer.

It’s a decision that keeps more people in danger. Here’s why.

Recently, the president announced that “it will be a crime to stockpile” several critical medical items including hand sanitizers. Without these items, both health care providers and patients are at high risk for the types of infections that affect 1 in 31 hospital patients every day. The Centers for Disease Control and Prevention (CDC) also notes that hand sanitizers can be effective at home if used correctly.

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The FDA, in recent guidance, has acknowledged that consumers and health care professionals are experiencing difficulties accessing alcohol-based hand sanitizers. Many hospitals are already out, and there are places where the product is needed because no sinks are available. The agency has also acknowledged that the need can be filled by distillers who can supply alcohol and compounders (like pharmacists, federal facilities and registered outsourcing facilities) who can make the sanitizer.

Some distillers have already stepped up, but there is a complication for others. The FDA has issued a “Temporary Policy for Manufacture of Alcohol for Alcohol-Based Hand Sanitizer Products During the Public Health Emergency” and stated that it will not “take any action against alcohol production firms” provided, among other things, that the alcohol used is not less than 94.9 percent ethanol by volume, the water used in the active pharmaceutical ingredient is sterile and the alcohol is “denatured.”

The FDA notes that denaturing – or adding unpleasant substances to deter consumption – is critical because if a child or otherwise confused person unintentionally drinks it, it can cause adverse events, including death. Pure alcohol can indeed kill. But when it’s denatured, it can still be toxic. The toxicity can also be increased by the purity of the alcohol FDA requires. 

Unfortunately, the two allowable denaturants are either in short supply or are not easily available in the United States. Beverage manufacturers would also have difficulty cleaning them from their lines later, so it would be a disincentive help now.

Either way, denatured or not, the type of alcohol used in hand sanitizer is dangerous to consume.

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Distillers have jumped in to help by supplying the alcohol they have on hand — much of which is undenatured alcohol. That product is safe, according to the World Health Organization (WHO) and the United States Pharmacopeia. In fact, the WHO discourages denaturing products because of the risk. 

The same problem applies to the FDA’s requirement of 94.9 percent-grade alcohol. The WHO requires only 80 percent, which is itself far more than the 60 percent minimum to be effective. Not only can many distillers not meet the FDA’s high requirement, but that high of an alcohol content is harsh on skin.

The problem here is that the FDA seems unable to move outside of its own comfort zone of highly precautionary standards — even when lives are at stake. We have seen this before. When people with HIV were dying in the 1980s and there was a drug available to save their lives, AZT, the FDA took seven years to approve it. They would not have done so without tremendous pressure from the patient community. More recently, the FDA dragged its feet while boys slowly died because of Duchenne Muscular Dystrophy

It remains to be seen how many distilleries will provide hand sanitizers, but we need fewer roadblocks. Alcohol manufacturers have been reluctant to go around the FDA, once called the “most powerful regulatory agency in the world.”

This is precisely the right time for elected leaders to step in and make decisions that are more in accordance with what is happening right now – what is needed urgently by the people they represent – and find a solution. After the crisis is over, they can go back and figure out whether we should return to a more precautionary standard, or they can look at where we may have gone wrong.

Richard Williams is a senior affiliated scholar with the Mercatus Center at George Mason University and a former director for social sciences with the FDA’s Center for Food Safety and Applied Nutrition.