Debarment for criminal companies?
This article was originally published in The Gray Sheet
Executive Summary
FDA should have the authority to kick criminal medical device companies and involved individuals out of the regulatory process, a Feb. 11 staff report from House Energy and Commerce Committee ranking member Joe Barton, R-Texas, says. Presently, only companies or individuals from the generic drug industry can be debarred if they are convicted of bribery, fraud, perjury or other crimes related to the FDA regulatory process. The report says the debarment provisions in the Generic Drug Enforcement Act, originally passed more than 15 years ago, should also extend to biologic, name-brand drug and animal drug companies. FDA has only used its debarment authority nine times, and has never debarred a company
You may also be interested in...
FDA Will Move Faster To Ban Bad Actors From Clinical Trials
Recent changes will speed FDA's process for barring non-compliant clinical trial investigators from future product research, agency staffers say
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.