Because major drug companies keep breaking the law with regard to illegal marketing of pharmaceuticals, officials with the Food and Drug Administration (FDA) are finally thinking about prosecuting executives of the companies.

 

In recent years, companies like Pfizer have been busted multiple times for selling their products for uses not approved by the FDA. Last year, Pfizer paid the largest settlement ever for off-label promotion—$2.3 billion—for unauthorized marketing of its recalled painkiller Bextra and three other drugs.

 

But the penalties don’t seem to be convincing Big Pharma to change its marketing ways because they look at the penalties as an operating expense rather than a deterrent. So tougher action may be required, says FDA Deputy Chief for Litigation Eric Blumberg.

 

“It’s clear we’re not getting the job done with large, monetary settlements,” Blumberg said. “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.”

 

If the FDA decides to go after company leadership, executives could face fines of up to $100,000 and one year in jail. The FDA also has the power to blacklist individuals from working in the drug industry.

 

Officials could be prosecuted using the Park Doctrine, which hold executives responsible for the actions of their underlings. The doctrine is named for a 1975 Supreme Court case, United States v. Park.

-David Wallechinsky

 

Drugmaker CEOs May Be Targets for U.S. FDA in Off-Label Cases, Lawyer Says (by Anna Edney, Bloomberg)

Smelling a Rat: Feds Threaten Drug CEOs With “Park Doctrine,” But What Is It? (by Jim Edwards, Bnet)

Pfizer’s Bad Week: Kickbacks, Whistleblowers, and Doctors on the Payroll (by David Wallechinsky, AllGov)

Drug Companies Find it Cost-Effective to Pay Fines and Keep Breaking Laws (by David Wallechinsky, AllGov)

Pfizer to Pay Largest Criminal Fine in History (by David Wallechinsky, AllGov)

Bush’s Last-Minute Gift to Drug Manufacturers (AllGov)