DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure

Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.

Disclosure
Companies must self-disclose misconduct directly to Department of Justice to get credit to avoid guilty plea • Source: Shutterstock

The US Department of Justice’s new policy of giving companies credit for voluntarily self-disclosing corporate misconduct has raised questions about whether communicating problems to the US Food and Drug Administration could count as timely disclosure.

Amanda Liskamm, director of DOJ’s Consumer Protection Branch, was asked about FDA’s role during a panel discussion at the Food...

More from Compliance

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By 

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.

More from Pink Sheet

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.