DOJ Prosecutors Turn Attention To Manufacturing, Safety Issues
This article was originally published in The Gray Sheet
The Department of Justice is increasingly tackling issues of FDA compliance beyond the standard sales and marketing fare, pursuing cases related to device manufacturing, adverse event reporting and even product labeling, recent cases suggest
You may also be interested in...
Firm's Guidant subsidiary will plead guilty to two misdemeanor charges related to its failure to include information in product safety reports to FDA, Boston Scientific announces Nov. 6. The plea is part of a settlement with the Department of Justice stemming from an investigation launched in 2005 by the U.S. Attorney's Office in Minneapolis (1"The Gray Sheet" Oct. 31, 2005). The federal investigators scrutinized whether then-independent Guidant made timely disclosures to FDA regarding malfunctions of its Ventak Prizm 2, Contak Renewal and Contak Renewal 2 implantable defibrillators. The products were the subject of a series of product safety advisories in 2005 amid criticism of industry and FDA processes for disclosing, tracking and responding to adverse event data. As part of the agreement, Boston Scientific will pay $296 million. On the same day, Boston Scientific disclosed to the Securities and Exchange Commission that it received a subpoena on Sept. 25 from the Health and Human Services Office of Inspector General requesting information relating to contributions made by the company's cardiac rhythm management division "to charities with ties to physicians or their families." The firm says it is "working with the government to understand the scope of the subpoena.
A $302 million settlement between Quest Diagnostics and the Department of Justice announced April 15 suggests DoJ will go after device firms for knowingly misrepresenting product information in labeling and marketing materials, even if FDA is not actively investigating the matter
Second read-out maintains 94% level of efficacy, with a very early signal that it could outperform Pfizer’s rival mRNA candidate in preventing severe cases.