J&J expects consent decree to extend through ‘most of 2013’
pharmafile | July 30, 2012 | News story | Manufacturing and Production | FDA, J&J, JJ, McNeil, OTC, recall
Johnson & Johnson has said it expects the production capacity issues affecting two plants covered by a consent decree with the FDA to extend through most of next year.
Three facilities in J&J’s manufacturing network are operating under the decree, which was implemented in 2011 after the FDA uncovered numerous violations affecting the some of the firm’s leading over-the-counter (OTC) pharmaceutical and consumer health brands, including Tylenol and Motrin.
The company also said recently it will strip out around 200 jobs at one of the affected plants – at Las Piedras in Puerto Rico – with the reduction equivalent to around a quarter of the workforce, according to an Associated Press report.
J&J’s consumer health subsidiary McNeil has been forced to recall millions of products as a result of the quality problems which emerged in 2009 and also affected manufacturing facilities in Fort Washington and Lancaster in the US.
Las Piedras and Lancaster are both bring upgraded whilst still in operation, while the Fort Washington plant is undergoing a $100m refit before it returns to production status.
The problems have forced J&J to slim down its McNeil product ranges and have contributed to declining sales at McNeil in recent quarters. Earlier this month, the company reported a near-5% decline in second-quarter consumer health sales to $3.6 billion.
“Production volumes continue to be impacted by additional review and approval processes,” noted J&J’s vice president of investor relations Louise Mehrotra on the firm’s second quarter conference call.
“We expect this to continue throughout 2012 and most of 2013. Plants operating under the consent decree will produce a simplified portfolio focused on key brands.”
J&J’s recently-appointed chief executive Alex Gorsky said that a year on from the signing of the consent decree “one of my highest priorities is to restore reliable supply of high quality OTC products to the marketplace and to do what it takes to continue to build trust in our products and brand”.
Phil Taylor
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
