Wyoming-based drugmaker Cody Labs is facing the shutdown of a portion of its business that contributes one-third of its sales. A U.S. district judge recently denied the company's request to halt FDA enforcement of a cease-production order that the regulator issued more than a year ago for unapproved morphine sulfate in 20-milligram-per-milliliter dosages.
The FDA had ordered the company to halt production by July 24, 2010, following a warning letter and two follow-up letters sent between March 30, 2009 and March 1, 2010. Cody and parent company Lannett in Philadelphia argue that the drug is grandfathered because of its use prior to establishment of the FDA and therefore requires no approval, according to a local press report. Cody began manufacturing its formulation about five years ago.
Cody also argues that the FDA has shown preferential treatment to its competitor, Roxane Labs in Ohio, which in January received approval for its previously marketed yet unapproved version of the drug. Cody's approval application, filed a month after Roxane's product was approved, currently awaits FDA action, projected for January 2011. The company also has not petitioned for a ruling on the grandfathering issue.
The FDA says it has an ongoing effort requiring makers of unapproved drugs to gain formal agency approval. It notified Cody and other drugmakers that, without marketing approval, they would have to halt production of 14 unapproved narcotics. The FDA's Unapproved Drugs: Enforcement Actions Internet page [1] currently includes 12 classes of drugs in addition to narcotics.
"If your firm manufacturers or ships/distributes your unapproved morphine sulfate oral solution 20 mg/ml product beyond July 24, 2010, that activity may result in legal action without further notice, including, without limitation, seizure and injunction," the regulator writes in the March 10, 2010, letter. "We encourage you to adjust manufacturing to prevent surplus morphine sulfate oral solution 20 mg/ml that may need to be destroyed. A copy of this letter will be forwarded to DEA."
- see the article [2]
- here's the 2009 warning letter [3]
- and the 2010 follow-up [4]
Links:
[1] http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm118712.htm
[2] http://billingsgazette.com/news/state-and-regional/wyoming/article_95305cb2-979e-11df-bd7f-001cc4c002e0.html
[3] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm131695.htm
[4] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/UCM202843.pdf