Regulatory Focus™ > News Articles > US Generics Firm Reports Counterfeit Cancer Drug Sales in Three Countries

US Generics Firm Reports Counterfeit Cancer Drug Sales in Three Countries

Posted 12 May 2016 | By Zachary Brennan 

US Generics Firm Reports Counterfeit Cancer Drug Sales in Three Countries

New Jersey-based generic drugmaker Heritage Pharmaceuticals last week announced that counterfeit drugs labeled the same as its 100mg chemotherapy BiCNU (carmustine for injection) have been sold and distributed in India, Ireland and Israel.

The injection is primarily used for the treatment of several types of brain cancer, multiple myeloma and lymphoma (Hodgkin's and non-Hodgkin) and according to the company, is also sometimes used for immunosuppression before organ transplantation or hematological stem cell transplantation.

Heritage said it’s working with the US Food and Drug Administration (FDA) to determine the source of the counterfeit drug and prevent its distribution into the US and elsewhere.

An FDA spokesman told Focus: “We are aware of counterfeit BiNCU outside the United States and are working to provide information to health care professionals. FDA urges patients and health care professionals to purchase drug products only from legitimate pharmacies licensed in the state in which they conduct business. We remain vigilant at the border to protect US patients from receiving counterfeit drugs.”

Heritage added that any customers who may have recently distributed BiCNU have been requested to convey this information to their customers, healthcare professionals and any others who use the injection so as to identify the characteristics of a suspected counterfeit.

Customers also have been instructed by Heritage to examine their inventory immediately and to quarantine, discontinue distribution of, and return any suspected counterfeits.

The notice comes as Heritage in November 2015 received a warning letter from FDA for failing to submit Periodic Adverse Drug Experience Reports (PADERs) for each of its abbreviated new drug applications (ANDAs) and for its failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of all postmarketing adverse drug events.

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