Court Ruling: Suspended Sentence and Heavy Fine for Falsifying Stability Data

Recommendation

12/13 September 2024

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A London court has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified data to the Medicines and Healthcare products Regulatory Agency (MHRA) in order to obtain a Marketing Authorization for a product. This was preceded by extensive investigations by the authority, during which thousands of scientific data files were analyzed and reviewed.

The defendant was sentenced to eight and seven months on two counts. He will not have to spend time in prison as the sentence was suspended for 18 months. However, both the defendant and the company must pay a fine of £50,000. The defendant must also pay the prosecution costs of over £80,000. A confiscation order of over £1 million, reflecting the profit from the crime, have already been confiscated.

What happened?

A press release dated 15 March 2024 states that "Evotrox Oral Solutions (a liquid solution containing the active ingredient levothyroxine) was licensed in 2006 in three strengths for the treatment of hypothyroidism (underactive thyroid)." As usual, the manufacturer also had to submit stability data as part of the licence application.

Back in 2008, reports emerged that the product was not stable for the whole duration of the shelf-life claimed in the original licence application. The MHRA took this as an occasion to launch an investigation. During this investigation, "the company continued to submit falsified data to the MHRA to try to support the medicine’s stability and effectiveness."

A comprehensive series of independent analyses by the MHRA and a detailed evaluation of the data seized from laboratory computers brought the falsifications to light. This culminated in the termination of the marketing authorisations by the MHRA in 2013 and subsequent criminal prosecution.

Statement of the MHRA

In the press release, Andy Morling, MHRA Deputy Director (Criminal Enforcement), emphasizes the complexity of the investigations. "Whilst the MHRA found no evidence that patients were harmed, the fact that the manufacturers were prepared to put them at risk by knowingly supplying a substandard product is very concerning." 

All in all, "this is a shocking case of a pharmaceutical company that thought it was above the law and was not required to uphold our stringent standards for safety, quality and effectiveness."