FDA Ready to Rumble: 3 To Dos for CEOs


For CEOs of companies regulated by the Food and Drug Administration (FDA), the message is clear: If you aren’t working to seek out and prevent off-label marketing within your company, you could be charged with a crime.

Rick Blumberg, Deputy Chief Counsel for Litigation at FDA, recently  spoke at the 7th Annual Medical Device and Diagnostic Compliance Congress. He said the FDA is looking for opportunities to prosecute individuals — and he gave CEOs as examples – using the Park strict liability doctrine.

The Park Doctrine requires that corporate officers and responsible managers will proactively:

  1. Seek out,
  2. Remedy, and
  3. Implement measures to prevent future violations.

If charged under the Park Doctrine, a CEO would have to show that she/he actively tried to find and prevent off-label use of a product.  The rationale is that those with authority must be held to a higher standard in the case of public interest and safety. They have to show that they steer their employees toward preventing wrongdoing.

What can CEOs do to prevent off-label use and avoid Park Doctrine prosecution?

1. Tell first. Terminate employees who engage in  off-label sales and marketing within your company and then report those individuals and the actions to the OIG and the FDA.

2. Ask often – and check. Conduct background checks on employees, and have sales and marketing staff file signed reports to a compliance officer about any off-label activity: their own, or anyone else’s. Then follow up on the reports.

3. Get people talking. Presentations, publications, in-service meetings, company hot lines for reporting – make sure your company culture speaks clearly and often about “no off-label use.”

You can see all of Rick Blumberg’s presentation here.

And while Blumberg listed 29 pharma settlements as examples of how bad the problem is, medical devices and biotechnology companies need to take note, too. It’s a new day, and the FDA is looking to rumble.

2 responses to “FDA Ready to Rumble: 3 To Dos for CEOs

  1. Pingback: Attacks on FDA’s Aggressive Stance: Off vs. On-Label | Good Promotional Practices

  2. seems FDA officers are also executing 3 dos, now tell first, good news for fair industry

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