Lawmakers Want Pharma Execs Criminally Liable for Withholding Safety Data

Two House Democrats have introduced legislation that would hold pharmaceutical executives criminally liable when they fail to disclose evidence of serious adverse events related to their products.

The Pharmaceutical Research and Manufacturers Accountability Act (PhRMA Act), introduced by Reps. Pete Stark (D-Calif.) and Marion Berry (D-Ark.), would impose stiff jail sentences and financial penalties on executives who knowingly withhold safety data. The legislation would also impose heavy fines on drug companies that don't meet FDA requirements for postapproval studies.

"It is unfortunate we need this legislation, but the only way to make manufacturers accountable for drug safety is to hit them where it hurts -- putting executives in jail and imposing large individual and corporate fines for wrongdoing," Stark told House members while introducing the bill.

To view the PhRMA Act, go to http://www.house.gov/stark/news/109th/legislation/PhRMAtext.pdf (http://www.house.gov/stark/news/109th/legislation/PhRMAtext.pdf).