FDA-Induced Shortages Are Nothing New | Opinion

By opening America's door wider to foreign imports of baby formula, the Food and Drug Administration (FDA) implicitly acknowledged its role in creating the shortage, a government-induced crisis that sent mothers scavenging through empty grocery store shelves in desperate attempts to feed their babies.

While boasting about military flights importing inconsequential amounts of baby formula, Health and Human Services Secretary Xavier Becerra stated that European baby formula is just as "safe and nutritious" as American baby formula. What he left out is the fact that FDA programs have been banning parents from buying it, even going as far as destroying it at the border, while babies risked starvation and even went to the emergency room.

As astonishing as it is to see these Soviet-style scenes in America, unfortunately, as the author of Ecclesiastes put it, "there is nothing new under the sun." This is not the first time FDA policies caused avoidable suffering for children and families.

Another FDA program you've likely never heard of, the Unapproved Drugs Initiative, made it harder for families to find—and afford—life-saving medicines.

Here's how it worked: FDA asked drug companies to gather new data on old drugs, some of which had been used for hundreds of years, and take them through the FDA approval process. In exchange, FDA would outlaw any other drug manufacturer from making and selling that drug—granting complete monopoly power to that company.

Once a drug manufacturer had no competition, their prices skyrocketed—in some cases by nearly 5,000 percent! The price of Vasopressin, used to treat critically low blood pressure and COVID-19 patients, increased more than 1,600 percent, and the price of colchicine, a drug Benjamin Franklin used to treat gout, shot up by more than 3,000 percent.

The program also created drug shortages. One infuriating example is dehydrated alcohol. Doctors use it to clean the feeding tubes of children with intestinal failure. In March 2020, FDA ordered all manufacturers off the market except the one company participating in the program. The price increased dramatically, doctors resorted to rationing care, and children ended up with potentially life-threatening infections.

As fathers of young children, we got to work trying to make this right. In Europe dehydrated alcohol was widely available and around 600 percent cheaper. We worked with desperate hospitals and doctors and attempted to facilitate importation during our final days in office, but ran out of time amid concerns the incoming Biden administration would not be friendly to importation. Those concerns proved valid.

The Unapproved Drugs Initiative is a swamp creation par excellence. It brought massive drug price increases and drug shortages, decreased domestic drug manufacturing, and harmed vulnerable patients. What about the benefits of additional data—did it at least produce that? No. A Yale University study found the program "rarely generated additional clinical evidence of safety or efficacy." So, lots of harm, and little benefit. We took responsible action, and shut the program down.

Baby formula shortage empty shelves
Shelves normally meant for baby formula sit nearly empty at a store in downtown Washington, DC, on May 22, 2022. - A US military plane bringing several tons of much-needed baby formula from Germany landed on May 22, 2022, at an airport in Indiana as authorities scramble to address a critical shortage. Samuel Corum / AFP/Getty Images

After getting President Trump to personally announce the termination, we joked that we had proved one of our favorite presidents, Ronald Reagan, wrong—he famously said, "government programs, once launched, never disappear. Actually, a government bureau is the nearest thing to eternal life we'll ever see on this earth!"

Sadly, the joke was on America. The Biden administration, where supposedly "policy and program decisions are informed by the best-available facts, data and research-backed information," brought the program back to life.

The Unapproved Drugs Initiative serves as a great illustration of how the administrative state threatens our constitutional system of divided government. The House did not vote on it, the Senate did not approve it, and no president signed it. Unelected FDA bureaucrats created it by fiat. By arbitrarily outlawing competing drug manufacturers, the executive branch both wrote and enforced federal law. So much for our democracy.

Our nation's food and drug laws are supposed to put Americans first. They are not there to provide employment for consultants, lobbyists, and attorneys who work to create profit opportunities for corporate interests on the backs of taxpayers, patients, and working families. And they certainly are not there to empower the unaccountable federal bureaucracy over our elected representatives.

As far as we know, doctors are still rationing dehydrated alcohol to care for sick children—our nation's most vulnerable.

In the United States of America.

In 2022.

In 2023, a new Republican Congress should finish what we and President Trump started by enacting legislation to send FDA's Unapproved Drugs Initiative to the ash heap of history.

Brian Harrison is a member of the Texas Legislature and served as Chief of Staff at the U.S. Department of Health and Human Services (HHS). James R. Lawrence, III served as a Deputy General Counsel at HHS and was outgoing Chief Counsel of the FDA. Both served under President Donald J. Trump.

The views expressed in this article are the writers' own.