Category Archives: Consent Decree

The Story of 3 Consent Decrees

by Barbara Unger, FDAzilla GMP Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence

A consent decree agreement is an agreement filed in the US courts formalizing a voluntary agreement between two parties.  Here we will address consent decree agreements between FDA and several pharmaceutical companies based on repeated failures to adequately address CGMP deficiencies.  It is not an action taken on the basis of a single form 483, or a single warning letter.  Generally, a series of events play out over time when critical inspection observations are not addressed and are identified in subsequent inspections.  Frequently one or more warning letters are involved.  Consent decree agreements often include fines, with the option for additional financial penalties if conditions to which the firm agrees are not met.  Often these firms are required to use a 3rd party consultants to perform lot release.  Firms operating under a consent decree agreement have largely lost their independence in GMP activities.  Unlike Corporate Integrity Agreement which have a defined duration, firms must petition to have the consent decree agreement condition rescinded.

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What Does Getting an 483 or Warning Letter Really Cost You?

“Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.”

I heard this from a reputable Head of Manufacturing of one of the largest biopharma companies in the world.  While most pharma and med device companies seems to learn quickly from everyone else’s mistakes, companies still occasionally get a “moderately bad” 483.  And then what happens after that? Continue reading

We Learned 5 Things from 2014 FDA and EU GMP Drug Enforcement Actions

2014 proved to be another busy year for the FDA.  We asked Barbara Unger, President of Unger Consulting and Editor-in-Chief of GMP Regulatory Intelligence, to summarize her key take-aways from the enforcement actions of the FDA and EU in 2014. Here’s Barbara: Continue reading

Top 30 FDA Stories | 2Q 2011

The FDA is having a very busy year.  Q1 saw a slew of approvals, policy changes, high-profile stories, enforcement activities, and personnel changes.  Q2 was no different.  Here are our top 30 stories on the FDA for Q2 of 2011.

The Big Stories of the Quarter

  1. The Drug Shortage:  Some people say the FDA is inadvertently at fault.  Some say the FDA prevented 38 close calls. Some say that the shortage is a niche business opportunity.  There was also some chatter that the FTC take these drug shortages into account when looking at M&A.
  2. The Avastin Battle: back and forth, back and forth, the FDA and Roche have gone. Finally last week, the FDA rejected arguments from Roche/Genentech that its approved anti-cancer drug  should continue as an approved therapy for advanced breast cancer.  Now that the science round is over, let the politics round begin.
  3. The other Triad/H&P Industries shoe drops. The big MSNBC lead story in February was just the beginning.  Here’s a good background post by PharmaLot.  And finally, in June, the FDA issued the consent decree. Continue reading

Top 30 stories on the FDA for Q1 2011


The first quarter of 2011 proved to be a busy one for the FDA.  We saw a deputy commissioner resign, a chemist charged for insider trading, a couple of big consent decrees, a big cancer drug approval, a big no-news on social media guidance, and more.  Here’s our wrap-up of the key developments. Continue reading

How to Lead Your Organization Out of a Consent Decree Crisis

It’s a most unfortunate tragedy that the approach taken by many when addressing underlying CGMP compliance issues is effectively based in a checklist mentality—a “To Do List.”  To be sure, solving fundamental regulatory compliance problems involves tactical work that is broken down into discrete executable steps. However, I become more convinced every day that the most significant challenges in life—regulatory, or otherwise—are more about “being” than “doing.” Continue reading

FDA Consent Decrees: How do you make compliance sustainable?

By the time a consent decree comes along, it’s no longer a discussion about responses to Form FDA 483s observations replete with well-turned phrases—it’s about a DIY Network renovation—a complete makeover. It’s a “gut-it” approach, as never before, which exposes the cracked foundation and termite-eaten beams weakened over time. Continue reading

FDA Consent Decrees: the Cost of Doing Business?

The strategic reasons behind the acquisition in the works for Sanofi to purchase Genzyme are clear. It was a matter of fixing a sale price that reflected the true current and future value of Genzyme.

For those of us in the quality assurance and regulatory compliance professions, there has been the curiosity of how the history of manufacturing and compliance woes at Genzyme would factor into the sale price.  Continue reading