How Are Clinical Trial Scandals Impacting FDA Regulations?

By Angela Woodall, Healthcare and Environmental Reporter

Mortalities are rare during a clinical trial, especially during the initial stages. But in January 2016, six men in France who had enrolled in a phase I trial of a pain relief drug suffered brain damage. One man died.

France’s health minister Marisol Touraine called the incident unprecedented. “I have no knowledge of a comparable event,” she told reporters.

There have been no clinical trials of the drug in the United States, according to the FDA. That does not mean, however, that the U.S. industry won’t feel blowback from the events that happened thousands of miles away. Indeed, judging from past experiences, the scandal could prompt the FDA to tighten regulations here, complicating efforts to make the nation’s cautious approval process more nimble.

In the meantime, FDA regulators began working with their French counterparts in the Agence Francaise De Sécurité du Médicament et des Produits de Santé to understand what happened to the six men who signed up to test the drug, which goes by the name BIA 10-2474.