By
Bill McCormick
With rising costs throughout the nuclear pharmacy industry, perhaps it should not come as a surprise that Jubilant Radiopharma’s Sales and Pharmacy Teams respond to an increasing number of questions about incredible cost savings available from suppliers who substitute non-FDA approved compounds for FDA-approved products. The harsh reality is that often these substitutions are non-disclosed or are offered without a clear explanation of the differences and risks associated with the use of non-FDA approved preparations.
As such, Jubilant Radiopharma’s policy is to procure and supply FDA-approved radiopharmaceutical products exclusively from FDA-approved cGMP compliant manufacturers. There are a couple of very good reasons we do this:
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First of all, non-FDA approved medications (those prepared by “compounders” that basically manufacture medications without the authority to do so and market them to nuclear pharmacy providers) put patients at risk because they are not prepared with oversight from the FDA.
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Second, they will create False Claims when claims are submitted to government payors. Only FDA-approved products are eligible for reimbursement by Medicare and Medicaid. Submission of claims for non-FDA approved preparations will result in False Claims exposure for the entity that submits them.
The growing prevalence of non-FDA approved preparations is a threat that our industry is taking very seriously. On April 30, 2014, Michael Guastella, executive director of CORAR (Council on Radionuclides and Radiopharmaceuticals, Inc.) went on record with a strongly worded letter (see PDF below) to the FDA’s Acting Director of Compliance. Specifically, Guastella wrote to alert the FDA to unlawful compounding practices of two nuclear pharmacies: AnazaoHealth Corp. and IsoRx Inc.; and he encouraged government regulators to be vigilant in monitoring risky compounding practices.
Despite pressure to compete with nuclear pharmacies that procure raw materials from “compounding pharmacies”, our refusal to substitute non-FDA approved drugs is a point of no compromise for Jubilant Radiopharma. As the recent tragedy associated with deaths traced to the New England Compounding Center reminds us: there is no cost savings that justifies putting lives at risk.
— Jubilant Radiopharma’s Managing Risks in Nuclear Medicine CE program, which addresses this important issue, is available live or online through the Online Learning Center.