J&J Procrit Counterfeits Return: Contaminated Product Found In Florida

Johnson & Johnson's Ortho Biotech division appears to have a recurring problem with counterfeiting of Procrit in Florida.

The company and FDA warned physicians March 8 about three lots of counterfeit Procrit (epoetin alfa) discovered in the state.

The counterfeit product appears as a clear liquid that is possibly water, Ortho's ¹ 'Dear Health Doctor' letter says. FDA's testing of the substance indicated it does not include active ingredient and is contaminated with Acinetobacter, Pseudomonas spp and potentially other bacteria.

The product is labeled as Procrit 40,000 units/mL and carries the lot numbers P007645 (expiration 10/04), P004677 (expiration 2/04) and P004839 (expiration 2/04). Ortho said that authentic Procrit bearing these lot numbers is likely to have already been used.

FDA's Office of Criminal Investigations discovered the counterfeit product as part of its ongoing investigation of earlier Procrit counterfeiting incidents.

Ortho issued three "Dear Doctor" letters in June 2002 and a follow-up letter in October 2002, warning of a total of three lots of counterfeit Procrit discovered in Texas and Florida.

The state of Florida is conducting a general investigation into counterfeiting and the secondary wholesaler market.

A recent report from a Florida grand jury recommends more stringent state regulation of wholesalers, including stricter licensing requirements and requiring wholesalers to verify documentation of each product's source (see ² (Also see "Wholesaler Arguments Against Rx Pedigree Papers “Weak” – Fla. Grand Jury" - Pink Sheet, 17 Mar, 2003.) ).

The report points to June 2002 Procrit counterfeiting as an example of an incident that could have been avoided by verifying the product's pedigree papers.

Attention to the counterfeiting issue could have an upside for the industry: highly publicized counterfeiting cases such as Procrit could help strengthen the case against open borders and drug reimportation.

Dangerous cases of counterfeiting could also serve as a reminder to Congress that FDA has delayed implementation of its final rule on drug pedigrees three times (most recently until April 1, 2004) so that Congress can enact the agency's recommended changes to the Prescription Drug Marketing Act (³ (Also see "PDMA Authorized Distributor Exemption Undermines Rx Drug Pedigree - FDA" - Pink Sheet, 9 Jul, 2001.), p. 6).

Ortho's letter to health care professionals includes a capitalized and bolded statement about the company's policy on Procrit ordering. The policy was first conveyed in the company's June 2002 packaging update.

"We are reminding you of our current policy: Any direct account that purchases Procrit, or any other Ortho Biotech product, from a source other than Ortho Biotech will have their direct account status terminated immediately," the letter declares.

"Hospitals, retail pharmacies and physicians may want to consider having their distributor/wholesaler sign a document that guarantees all Ortho Biotech product is purchased directly from Ortho Biotech."

The letter also cautions against purchasing Procrit that has been repackaged.

"A number of companies are now offering Procrit and other biological products in pre-filled syringes to hospitals, pharmacies and physician's offices. These companies draw up product from the original product vial into a pre-filled syringe and provide it to hospitals or offices by courier or express mail service," Ortho said.

"The inability to authenticate the product at the end-user site is a major concern with this practice along with exposure to out of range temperatures, questions of sterility/contamination, and vibration of the protein during shipping that may lead to alterations in stability. Ortho Biotech does not endorse or condone this practice. As such, the repackaging center and the customer of such services assume all risk associated with this practice."

Ortho issued updates on packaging changes in late June 2002, October 2002 and most recently Jan. 22. The company began placing color-shifting seals on the tuck-flap of Procrit cartons in July 2002, and said in January that it has completed this step.

The company is in the process of implementing its most recent packaging change: color-coded flip-caps and aluminum bands on Procrit vials, corresponding to each vial's formulation and strength. The transition to the new bottles is expected to be completed by the end of the third quarter.

Ortho said some measures taken to date should help differentiate the most recent counterfeits from authentic Procrit, such as carton closure seals that leave a residue and reveal the words "OBPLP VOID" when removed.

The company said in a statement that the counterfeits "can be easily detected visually" based on pictures posted on its website and included in the letter. In addition to the carton closure seals, the differences include a 1/16 inch discrepancy in vial height, a label that may be pulling away from the vial, dented aluminum wrapping under the vial cap and differences in the appearance of text on the product cartons.

Ortho said it has not received any reports of patients receiving the counterfeit product found in Florida but is in the process of evaluating adverse event reports for those that could be related.

"The counterfeit product may pose a serious health risk for patients if injected, especially those who are immune compromised," Ortho said.

Procrit's patient population includes those likely to have weakened immune systems. The product is indicated for the treatment of anemia in patients with chronic renal failure, HIV patients taking zidovudine, cancer patients on chemotherapy, and surgery patients at risk for transfusion.

Ortho distributed approximately 180,000 copies of the "Dear Health Care Professional" letter, a wider population than the 100,000 health care professionals contacted via Ortho's previous letters.

In addition to expanding the list of wholesalers, doctors and hospitals notified, Ortho also sent the March 8 letter to orthopedic surgeons and retail pharmacists, two groups not included in earlier mailings. Patient groups in the areas of cancer, HIV/AIDS and kidney disease have also been notified.