Italian Antitrust Regulators Fine Pharma Company For ‘Excessive Pricing’ of Disease Drug

Italian Antitrust Regulators Fine Pharma Company For ‘Excessive Pricing’ of Disease Drug

June 5th, 2022 // 7:41 pm @

Antitrust officials in Italy fined a drugmaker almost $4 million last month for years of what they termed ‘excessive price hikes’ for a rare disease drug. This is the latest occurrence in Europe where regulators are dropping the hammer on pharmaceutical companies for allegedly overcharging customers.

The medicine involved is called CDCA and is used to treat patients with cerebrotendinous xanthomatosis, also called CTX, which is a very rare metabolic disease. A version of the drug was available for many years that was inexpensive, but the medicine was purchased by Leadiant Biosciences eight years ago and started raising the price in several nationals before it was pulled from the market.

But the firm brought the drug back in 2017 after the EMA determined that CDCA is an orphan drug. The move gave Leadiant 10 years of exclusivity rights or monopoly protection. But CDCA isn’t a new drug molecule. When a company gets an orphan drug designation, the idea is to give incentives for pharma to make new drugs for rare diseases and conditions.

However, the Italian Competition Authority said that Leadiant charged about $16 per package for the drug. But the price only came down after the regulatory body investigated high pricing in December 2019. An economic analysis showed that the pricing for the drug was still too high.

ICA said it determined that there was pricing abuse for many years and it was pursued on purpose. However, the company said it strongly disagrees with the ICA’s allegations and will challenge the ruling in the Italian Administrative Court.

This type of action has happened in other parts of Europe. In 2021, The Netherlands levied a $23 million fine against Leadiant for excessive price increases, but the fine was suspended. In 2020, the National Authority for Markets and Competition in Spain also investigated price gouging by Leadiant.

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