A new gene therapy drug named Zoglensma became the most expensive drug in the world, costing patients over $2.1 million for one-time use. Zoglensma joins a small (and outlandishly expensive) group of treatments called gene therapy drugs. Gene therapy uses actual genes to treat or prevent diseases.

Before Zoglensma’s approval, its predecessor treatment, named Spinraza, cost patients $750,000 for the first year’s treatment and an additional $375,000 for each additional year. Other FDA approved gene therapy treatments cost between $375,000 and $875,000.

Zoglensma treats spinal muscular atrophy (SMA), a rare genetic disease that restricts the nervous system’s ability to coordinate voluntary muscle movement. Nearly one in eight-thousand people carry the SMA gene. Tragically, the disease typically affects infants. In severe case, infants with SMA are unable to sit upright, suffer from severe joint pain, and ultimately die from respiratory failure. SMA is considered the most common genetic cause of death in infants.

Despite providing rare and promising results, many gene therapy drug prices place them beyond financial reach for many families in tragic situations. But why are these treatments so expensive?

A significant reason is government regulation.

Unlike other drugs regulated by the Food and Drug Administration, gene therapies are subject not only to the regulatory structure of the FDA, but also to the Office of Biotechnology Activities, and the Recombinant DNA Advisory Committee. Excessive regulatory oversight creates an elongated and expensive route to approval. By one estimate, an approved gene therapy drug costs nearly $5 billion (five times as high as the average cost of FDA approval). Covering these costs is difficult because many of the diseases gene therapy drugs treat are extremely rare.

Gene therapies are also often tailored to specific individuals, making completing clinical trials for FDA approval very challenging and costly. One estimate holds it costs drug providers nearly $1 million per clinical trial participant. For reference, the first phase of the FDA approval process typically requires twenty to eighty participants. The third and largest phase usually requires at least 3,000 participants.

Gene therapies provide those with rare, serious, and possibly terminal conditions with the ability to significantly improve their quality of life. When pioneering medical breakthroughs provide such an opportunity, it is imperative to provide treatment where possible. Existing regulations serve to hinder access to treatment by making it prohibitively expensive. Drugs costing over $2 million are the latest symptom of the overregulation disease.

The FDA recently committed to deregulating the frozen cherry pie market. Specifically, the agency is re-examining current regulations dictating that frozen cherry pies are required to be at least 25 percent cherries by weight and that no more than 15 percent of these cherries may be blemished.

The FDA has dedicated considerable effort to publicize its efforts. As (recently resigned) FDA Commissioner Scott Gottlieb tweeted, the agency considers deregulating cherry pie to be “among other high priorities.” He later referred to the initiative as “a down payment on a comprehensive effort to modernize food standards to reduce regulatory burden and remove old-fashioned barriers to innovation.”

Some thought Gottlieb was joking. But those who believe the FDA involving itself in determining how many cherries should be in cherry pie might not know how wacky frozen pie regulations have become.

The agency has been regulating frozen pies since 1977. In that time, it has developed numerous additional regulations specifying what makes cherries blemished, what counts as frozen, and how much crust is needed to cover the pie. Frozen cherry pies are also the only fruit pies which must meet these standards.

Even bakers seeking political favors (yes, they exist) are eager to see such outlandish regulations eliminated. As one New York Post article reports, Lee Sanders of the American Bakers Association is “hopeful the cherry pie standard will finally be revoked, but that it would not make a big difference for the industry.” It’s not every day you find a regulation so poorly executed that not even special interest groups support them.

Regardless of how the regulation passed, and how long overdue removing it is, we should be happy it will soon be gone. Maybe next the FDA will loosen its requirements on the size of the holes in Swiss cheese.