The Competition and Markets Authority said Thursday it reached the preliminary view that the companies “exploited a loophole by de-branding the drug known as Epanutin prior to September 2012,” so that its price wasn’t regulated the same way as other branded drugs.
“Thousands of patients depend on this drug to prevent life-threatening seizures as a result of their epilepsy,” Andrea Coscelli, the CMA’s chief executive officer said in the statement. “This is a matter that is important for government, for the public as patients and taxpayers, and for the pharmaceutical industry itself.”
The provisional decision follows a 2020 ruling by the U.K. Court of Appeal that decided the CMA’s previous investigation was “insufficiently deep or intense.” The U.K. watchdog in 2016 fined Pfizer a record 84.2 million pounds ($117 million) and Flynn 5.2 million pounds for increasing their prices as much as 2,600% in September 2012 for unbranded versions of the Epanutin anti-epilepsy drug.
Pfizer will have the possibility to respond to the CMA’s so-called statement of objections before a final decision is adopted. The company said it “continues to co-operate fully with the CMA’s ongoing investigation.”
“Ensuring a sustainable supply of our products to U.K. patients is of paramount importance to Pfizer and was at the heart of our decision to divest the product in 2012,” it said in an emailed statement.
Spokespeople for Flynn didn’t immediately respond to a request for comment.
The CMA said it decided to re-investigate the case after last year’s court ruling and opened the new probe in June 2020.
