Citizen Petition to FDA Increases Pressure to Regulate Manufacturing of Copy-Cat Radiopharmaceuticals

All around us, the storm rages on about the use of non-regulated, non-FDA approved products in the practice of nuclear medicine. Most recently Jubilant DraxImage (JDI) — the Canada-based manufacturer of I-131 (HICON®), DRAXIMAGE® MAA and DRAXIMAGE® MDP/MDP-25  — submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) that calls for the FDA Commissioner to take immediate action to correct disparate treatment of compounding pharmacies and other facilities that produce and distribute non-FDA approved products.

Jubilant Radiopharma Radiopharmacies Division is in full support of this call to action. Bill McCormick, my predecessor and colleague, articulated our refusal to substitute non-FDA approved drugs is a point of no compromise for our company and team members.

Two primary issues are at the heart of JDI’s complaint, which is echoed by others throughout the nuclear medicine industry. (See recent letter from CORAR executive director to the FDA Office of Compliance.)

JDI’s Citizen Petition initially discusses seemingly disparate treatment by the FDA of compounding pharmacies and other facilities that are manufacturing unregulated “copy-cat” versions of FDA-approved products. They assert that facilities producing unauthorized copies of FDA-approved, commercially available products are not held to the same standards as the approved manufacturers, as follows:

In order to produce and distribute drug products on a large scale nationwide, Petitioner and other manufacturers producing FDA-approved drugs are required to adhere to all of the FDCA requirements for manufacturers. Nuclear pharmacies and outsourcing facilities, however, that engage in manufacturing and wholesaling of what are essentially copies of approved drugs are not being subjected to these same standards and requirements.”

The second major concern raised in JDI’s complaint is that of public safety and welfare. In strongly worded language, it is asserted that public interest compels this disparate treatment be stopped:

The FDA is treating radiopharmaceutical manufacturers and their products differently than it treats facilities engaging in manufacturing and wholesaling activities (and their products) without a rational basis. … By taking these actions, the FDA is ignoring its mandate to protect the public from unsafe compounded drugs, and to maintain the integrity of the premarket approval process for new drugs, including radioactive drugs.”

Specifically, JDI’s Citizen Petition requests action by the FDA to do the following:

  • Cease carving out compounding pharmacies that are manufacturing copies of FDA-approved products from the FDA’s federal jurisdiction and requirements.
  • Treat manufacturers and wholesalers of radiopharmaceuticals operating under the guise of compounding pharmacies or outsourcing facilities, and their copy-cat products, substantially the same as the FDA treats manufacturers producing FDA-approved products, with the same requirements to comply with the FDCA.
  • Prohibit the production by compounding pharmacies and outsourcing facilities of drugs that are copies, or essentially copies, of FDA-approved commercially available products, in the absence of a drug shortage or when this is not supported by sufficient documentation of medical significance for a specific patient.

In addition, the petitioner calls for immediate remedies to address, in particular, the manufacturing and distribution practices of one specific commercial pharmacy operation that is named in the complaint.

While recent public health tragedies involving the nationwide distribution of non-FDA approved products has increased scrutiny of this practice, it has not yet brought unregulated and unsafe processes to a halt.

As an industry, we cannot sit by and allow this to continue. In fact, we have an absolute responsibility to “be the change we want to see.” Not only is it essential that we add our voices to the outcry for regulatory changes, such as those outlined in the JDI Citizen Petition; but we must also refuse to take the risk of using non FDA-approved products in our daily practice of nuclear medicine. To echo Bill McCormick’s observation on this topic: “There is no cost savings that justifies putting lives at risk.”