The Fort Washington facility was shuttered in 2011 after US FDA inspections found contamination in several over-the-counter children’s medicines, including Tylenol and Motrin.
J&J Group Worldwide Chairman Sandi Peterson told investors the company “recently had a successful FDA inspection in Fort Washington and are awaiting final notification” before production can start again. The company is currently advertising for staff at the site.
She added J&J has “remediated and relaunched” its OTC business, with 80% of products back on the market, and Tylenol Arthritis – one of the drugs manufactured in the past at Fort Washington – set to launch soon.
A permanent injunction from a Pennsylvania District Court means J&J must overhaul the facility before it can reopen, while a 2011 Consent Decree requires an FDA green light before Fort Washington can restart manufacturing.
The same decree kept open J&J facilities in Lancaster, Pennsylvania and Las Piedras, Puerto Rico but subjected them to several years of strict compliance inspections. Peterson announced the FDA has now certified the two sites as cGMP-compliant.
J&J CEO Alex Gorsky commented on reinstating the OTC portfolio, saying investors had previously been sceptical about the company’s ability to introduce branded pain drugs against generic competitors.
But the company is regaining market share, he said. “I think we are back up to now about 60% of the share that we achieved in areas like pain. So we are building our way back up.”
The company has spent the last few years investing in preparations for the OTC relaunch. This funding will continue, said Sandi Peterson, as the company chases higher manufacturing profitability via Cost of Goods Sold and gross margins.
J&J business unit McNeil-PPC pled guilty this year to the misdemeanour crime of selling adulterated medicine under the federal Food, Drug and Cosmetic Act (FDCA) and paid $25m (€23m) in fines.
Complaints date back to 2009 when a customer noticed “black specks in the liquid on the bottom of the bottle” of Infants’ Tylenol (paracetamol). The matter turned out to be nickel-chromium, but McNeil-PPC failed to activate a Corrective Action Preventive Action (CAPA) plan as required by cGMP.
Justice Department prosecutor Benjamin Mizer said at the time McNeil’s failure to comply with cGMP was “seriously troubling”
In 2010, McNeil recalled its Tylenol Arthritis Pain caplets after patients experienced stomach pain and the pills were found to have a “musty” odour, attributed to 2,4,5-tribromoanisole which had leaked from wooden pallets.
In the time between FDA inspections of the facility in 2009 and 2010, the company picked up on particle problems in 30 batches of OTC liquid drugs, including Children’s Motrin (ibuprofen) and two forms of Tylenol.
J&J issued large-scale recalls of many OTC drugs for infants and children manufactured at Fort Washington before receiving an injunction against production at the site.
The company has previously been overambitious in its recovery schedule. A spokesperson told in-Pharmatechnologist.com in 2013 the plant was “on track” for reopening in early 2014.