3 FDA 483 Stories in the Last 3 Weeks – Gilead, Alexion, and Novartis

Now I know why we’ve been getting more calls/emails from financial institutions and hedge funds inquiring about FDA 483s – more and more investors are being introduced to the term during investor calls. While technical in nature, digging through a company’s history of 483s – especially when compared to competitor company’s profiles – can uncover potential vulnerabilities in their manufacturing systems.

In the last few weeks, there have been 3 stories around 483s in the biopharma world.  Biopharma executives are literally addressing 483s – their contents and context – during their quarterly investor conference calls.

Alexion’s Contamination gets an FDA warning letter. Looks like Alexion took the FDA’s advice to bring in the hired guns (who cleaned up shop swiftly and quickly).   As it typical in higher-profile cases like this, the FDA released the FDA 483 in question.  And in a somewhat unusual move, the FDA also released Alexion’s response (in all of its 22-page glory – just 16 days after the issuance of the 483).

Novartis cut 300 jobs in OTC Plant Restructuring after 483.  Joseph Jimenez, CEO of Novartis, suspended manufacturing at their Lincoln, Nebraska site in December 2011 and has cut 300 positions “ensure the sustainability” of the facility in the future.  The $50M in exceptional expenses to restructure the facility is the least of their concerns – some estimate that lost revenues from the manufacturing shut-down could be upwards of $1 billion.

Gilead Sciences shared during their 1Q investor call their response to a Form 483. As reported by the WSJ, “The letter cited deficiencies in the company’s laboratory records and test procedures, stability testing and laboratory controls.”  Norbert Bischofberger, an EVP of Gilead Sciences, said, “People have been working 24-seven since the FDA inspection started, so I have great comfort that we will overcome this little setback.”

Related FDA 483 Resources

 

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