Antitrust regulators in Spain have fined a drugmaker $10.6 million for years of “excessive” price hikes on a rare disease medicine, the latest instance in which European authorities have cracked down on the pharmaceutical industry for harming consumers and taxpayers.
At issue is a medicine called CDCA that is used to treat people with a rare genetic metabolic disease known as cerebrotendinous xanthomatosis, or CTX. There was a low-cost version available for decades. But the drug was bought by Leadiant Biosciences which, by 2014, began raising the price in several countries before withdrawing the medicine from the market entirely the following year.
However, the company brought the medication back to the market in 2017 after the European Medicines Agency designated CDCA as an orphan drug. The move gave the company 10 years of monopoly protection, although CDCA was not a new molecule. Orphan drug designations are meant to provide incentives to create new medicines for rare diseases.
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