Post-Market Study Or Marketing Plug? Government Attorneys Are On Watch
This article was originally published in The Gray Sheet
Executive Summary
Government investigators say they are increasingly on watch for post-market device studies designed to make a sale or explore an off-label use, rather than for bona fide clinical research.
You may also be interested in...
News In Brief
St. Jude Medical inks DOJ settlement
Boston Scientific settles kickback charges
Firm will pay $22 million to settle civil charges that its Guidant subsidiary used four post-market studies as vehicles to pay kickbacks to physicians for implanting its defibrillators and pacemakers. Guidant, which was acquired by Boston Scientific in 2006, allegedly paid participating physicians $1,000-$1,500 per study in 2003 and 2004. The settlement, announced Dec. 23, closes a Department of Justice investigation initiated in 2005 into Guidant product feedback surveys (1"The Gray Sheet" Oct. 31, 2005). Boston Scientific admits no wrongdoing under the settlement, which also includes a corporate integrity agreement with the HHS Office of Inspector General. The agreement requires the company's cardiac rhythm management business to publish its payments to doctors on the Internet, as well as make "enhancements to certain compliance procedures related to financial arrangements with health care providers," according to Boston Scientific. Although device and drug makers "can use post-market studies legitimately to obtain information about how their products work in the field, they cannot use those studies, and the honoraria associated with them, to induce physicians to use their products," said U.S. Attorney Carmen M. Ortiz. Boston Scientific recently settled a separate Justice Department investigation, also initiated in 2005, into possible lapses in Guidant's product safety reporting to FDA (2"The Gray Sheet" Nov. 9, 2009)
Who’s Hired? Hikma Recruits New US Generics President
A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris announcing new hires while focusing on their targets for the year.