A group of pharmaceutical executives wrote a letter to Belcher Pharmaceuticals, criticizing the drugmaker for raising the price of dehydrated alcohol by almost 670 percent, STAT reported.
Dehydrated alcohol has been around for decades and is used to treat chronic pain or prevent infections in patients who need nutrients intravenously.
Older versions of the drug sold by other manufacturers were never FDA approved, but were available because they predated stricter FDA requirements.
In June 2018, Belcher Pharmaceuticals received FDA approval for its version of dehydrated alcohol, called Ablysinol. It received orphan designation, a special status given to drugs that treat rare diseases, because Belcher asked for it to be approved to treat a rare cardiac disease.
Other drugmakers sold it for about $1,300 for a 10-vial pack, but Belcher is selling it for $10,000 for the same amount.
Orphan designation means other drugmakers can't market their versions of dehydrated alcohol until 2025, so Belcher's is the only kind on the market, forcing healthcare providers to pay the higher price.
Belcher justified the price hike by saying it spent "multiple millions of dollars" on developing the drug, running clinical trials and preparing its application for the FDA. But Belcher didn't run its own clinical trials. It relied on previously published research, according to an FDA review.
The drugmaker did conduct its own stability studies.
"Those other companies can charge whatever they want because they’re unapproved. They never did any studies. We had to develop the drug. We can't trust what’s unapproved," Fabio Lanzieri, president of BPI Labs, a Belcher subsidiary, told STAT. "A drug that’s never been approved means nothing to me, because no test was done. You can’t prove safety and efficacy. We had to prove all that."
A group of pharmaceutical executives — the same ones who signed a letter published Jan. 8 in STAT promising to price drugs "reasonably" and to improve drug access — posted an open letter Feb. 19 to Belcher, saying the price hike is a misuse of orphan drug designation.
The executives argue in the letter that orphan drug designation is supposed to encourage drug development, not reward new versions of existing treatments, STAT reported.
"In our view, seven years of exclusivity based on existing published research and knowledge is a misuse of the Orphan Drug Act and serves as new fodder for the arguments around fair and equitable drug pricing by biopharma companies. It also potentially could compromise the ODA itself, harming the act’s ability to deliver enormous benefits to patients with rare diseases," the executives wrote.
The executives said Belcher needs to explain what new innovation its drug brings and provide evidence to justify its price hike.
Becker's Hospital Review has reached out to Belcher for comment and will update this story accordingly.
Editor's note: This article was updated Feb. 21 at 3:40 p.m.
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