FDA Cracks Down On Unapproved Oral Colchicine

The US Food and Drug Administration (FDA) just ordered a halt to the marketing and took action against companies that manufacture, distribute, and/or market unapproved single-ingredient <"https://www.yourlawyer.com/practice_areas/defective_drugs">oral colchicines, a drug commonly used to prevent gout, treat gout flares, and treat Familial Mediterranean Fever (FMF).

The companies are expected to stop manufacturing single-ingredient oral colchicine within 45 days and must stop shipping this unapproved product in interstate commerce within 90 days. A small amount of unapproved colchicine is expected to be available after these dates until supplies are exhausted.

The medical community has used many single ingredient oral colchicine products for decades. These and a variety of other medications have not received the mandatory modern-day FDA-approval required of all prescription drugs.

Colcrys is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market. Approved by the FDA in 2009, Colcrys’ prescribing information contains important safety data and recommendations on drug interactions and dosing not available with unapproved products.

The manufacturer of Colcrys, Mutual Pharmaceutical/URL Pharma, has established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure all patients will be able to continue affordable access to colchicines and has informed FDA that it will maintain PAP and CAP at a minimum until there is FDA-approved generic competition for Colcrys.

PAP covers three groups: Those with insurance; those without insurance; and Medicare beneficiaries enrolled in Part D who do not want the cost of Colcrys to contribute toward their true out-of-pocket expenditures under Part D. CAP helps eligible patients reduce their Colcrys prescription co-pay to no more than $25 per prescription. Specific information on these programs can be found at www.colcrys.com, www.needymeds.org, or by calling 1-888-811-8423.

The FDA noted that this action is part of its broader initiative against marketed unapproved drugs, announced in a June 2006 Compliance Policy Guide describing the agency’s risk-based enforcement approach for marketed unapproved drug products. “The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients.”

Unapproved versions of colchicine are not generic drugs. Of note, generic drugs are approved by the FDA to ensure approved generic drug products meet the same standards as the innovator, or original, drug. All single-ingredient oral colchicine products, other than Colcrys, currently being marketed are unapproved and were never evaluated by the agency.

The FDA previously took action against unapproved colchicine for injection products on February 6, 2008.