FDA Pressure Likely In Novartis OTC Plant Shutdown, Recalls
This article was originally published in The Tan Sheet
Executive Summary
FDA inspectors were in Novartis Consumer Health’s Lincoln, Neb., plant in December and January, as the company was deciding to halt production and recall products. An inspection report notes 10 observations – eight of them repeats from FDA’s visit in mid-2011.
An FDA inspection report suggests the agency influenced Novartis Consumer Health Inc.’s decisions to cease production at its Lincoln, Neb., facility and recall OTC products.
While the company stated its actions were voluntary, precautionary measures, a Jan. 20 form 483 from FDA’s Lenexa, Kan., district office shows a follow-up inspection was ongoing when Novartis AG made those decisions.
FDA inspectors were in the plant Dec. 19 – the day Novartis AG stopped shipments from Lincoln – and on Jan. 6 – two days before the firm recalled Excedrin and other OTC products (Also see "Novartis Opts For OTC Recall, With J&J/McNeil Lessons Still Fresh" - Pink Sheet, 16 Jan, 2012.).
Further, with 10 agency observations to correct – eight of them repeats from a mid-2011 inspection – Novartis’ remediation of the 150,000-square-foot Lincoln plant could stretch beyond summer 2012, the facility’s projected return to operability (Also see "FTC goes after QVC" - Pink Sheet, 29 Mar, 2004.).
At a J.P. Morgan analyst conference Jan. 9, Novartis CEO Joseph Jimenez discussed the Swiss company’s determination to apply the same best-in-class manufacturing quality standards across its operations. He did not mention the presence of FDA inspectors at the Lincoln plant that same day.
“We took the Lincoln site down temporarily in the month of December so that we could accelerate maintenance and improvements at that site,” Jimenez said. “During the process of that shutdown and the investigation of the consumer complaints, we were getting a large number of complaints around chipped and broken pills [and] stray tablets, so we decided to go get that product and bring it back.”
Prevacid 24HR In The QC Problem Mix
After inspecting the Lincoln plant on 12 days across June and July last year, FDA inspectors returned five months later and were on site 21 days between Dec. 14 and Jan. 20.
The more recent form 483 submitted to Novartis Consumer Health, posted on FDA’s website Jan. 27, says the firm’s failure to follow quality control procedures fully affected the recalled Bufferin, Excedrin, Gas-X and NoDoz products, as well as Prevacid 24HR, which was not recalled.
FDA says the proton pump inhibitor, like the other OTCs, was part of inadequately investigated product mix-ups, including one consumer complaint of a bottle of Excedrin packaged in a Prevacid 24HR carton.
Novartis Consumer Health “was aware of partial/incomplete Bufferin tablets/caplets issues since at least 2009. … There is no justification or explanation for the approximate two-year delay.”
–FDA inspection report
As of Dec. 12, NCH had a backlog of approximately 1,360 consumer complaints remaining to be investigated fully – 31 of which were “critical,” FDA says.
The agency found NCH tended to close investigations without fully addressing root causes. For example, the company received 80 consumer complaints regarding partial tablets in a single lot of Bufferin but did not act in a timely fashion, FDA says.
“Your firm was aware of partial/incomplete Bufferin tablets/caplets issues since at least 2009, yet a medical safety assessment report was not released until [Oct. 14, 2011]. There is no justification or explanation for the approximate two-year delay in obtaining this report,” according to the form 483.
The agency also calls out NCH for failing to recall potentially mixed-up tablets until FDA’s inspectors were in the Lincoln facility – representing a delay of at least two years after the firm began receiving mixed product complaints.
Doubt About Six-Month Turnaround
Morningstar analyst Damien Conover saw enough from Johnson & Johnson’s prolonged OTC quality problems to know Novartis’ issues are not as severe. Still, he said in an interview he expects the Lincoln remediation to last at least through 2012.
If recent history is a guide, Novartis could be hard-pressed to turn around the Lincoln plant in six months. J&J submitted a remediation master plan to FDA for its troubled Fort Washington, Pa., facility in July 2010; the plant now is slated to resume production in 2013 (Also see "Andrx Concerta" - Pink Sheet, 29 Mar, 2004.).
After Perrigo Co. PLC’s Allegan, Mich., facility received an FDA warning letter in April 2010, executives curtailed production there and said they hoped the agency would return for a re-inspection in November that year. Ultimately, it took until April 2011 for the private labeler to get FDA’s go-ahead to restart full production at the site (Also see "Perrigo Takes Two Steps Forward: Generic Allegra Launch, Manufacturing Compliance" - Pink Sheet, 18 Apr, 2011.).
Conover thinks Novartis likely is done with OTC recalls for now – J&J’s extensive recalls in 2009 and 2010 taught other companies to “try to nip everything in the bud,” he said – but the issues at Lincoln could remain a major stumbling block for the otherwise well-positioned, diversified pharma company.
“Despite the company’s solid overall strategy, manufacturing issues in the consumer division as well as an increasingly competitive generics industry will weigh on the company’s near-term prospects,” Conover wrote in a Jan. 30 research note.
A Novartis spokeswoman reiterated the company conservatively estimates that OTC shipments will resume from Lincoln mid-year. The firm is investing in upgrades and training at the facility, she said in an email.
Novartis also is evaluating possible alternative sites for supplying the OTC products made at Lincoln, she added.