DoJ and GMPs: A Prosecutor’s Take on Enforcing Product Quality

The wave of marketing promotions undertaken by the Department of Justice over the past decade may be abating, but prosecutors are looking at manufacturing violations as fertile new territory for cases. One prosecutor shares her thoughts on how companies can protect themselves.

We do not see our work as a list of statutes to enforce or collection of areas of law in which we practice. Rather, our focus is on the mission of protecting consumers, and our highest priority is to protect consumers where they are most vulnerable—where the harm to consumers is widespread and substantial or where consumers are at greatest risk of harm.

More from Legal & IP

More from Pink Sheet

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.