FDA aims to step up criminal prosecutions

The FDA plans to go after more drug company executives with criminal charges as a way to hold management personally accountable and to better enforce rules governing drugmaker conduct.

According to the Wall Street Journal, the agency already has the authority to prosecute corporate executives for criminal actions their companies take. To get a conviction, the agency doesn't have to show that the manager actually intended to defraud anyone. This particular power hasn't been used much in recent years, an agency official told the newspaper.

The FDA won't say what sorts of misconduct it might pursue in this way, but the idea is to choose its battles carefully.

The new approach apparently is part of a turnabout at the FDA's Office of Criminal Investigations, which the Government Accountability Office criticizes in a report released today. The GAO says that the criminal office has operated with too much autonomy and too little accountability to top FDA officials.

- read the GAO report (.pdf)
- see the WSJ story

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.