Jubilant Radiopharma, Radiopharmacies Division Participates in Recent NANP Legislative Visit to Washington, D.C. to Discuss Unlawful Compounding of Radiopharmaceuticals

On April 18, Nick Plumeri, Jubilant Radiopharma, Radiopharmacies Division's  Business Unit Director, Northeast Business Unit, and I traveled to Washington, D.C., to participate in National Association of Nuclear Pharmacies (NANP) annual legislative visit to our nation’s Capitol to discuss industry issues and concerns. For those who are unfamiliar with NANP, the association was founded in 1984 and is a non-profit industry association of approximately 350 nuclear pharmacies in the United States. This membership represents the vast majority of nuclear pharmacies and includes large commercial chains, and independent and institutional nuclear pharmacies. 

Those in attendance this year included: (pictured below, from left, in U.S. Senate Majority Leader Mitch McConnell’s office at the Capitol) Danny Allen (NuTech), Scott Claunch (Cardinal Health), Jeff Norenberg (executive director and chairman of NANP), Jay Lilly (Jubilant Radiopharma, Radiopharmacies Division), David Barnes (GE Healthcare), Wayne Boudreaux (Cardinal Healthcare) and Tim Quinton (Radiopharmacy, Inc.); and (not pictured) Rebecca McGrath (Cardinal Health) and Nick Plumeri (Jubilant Radiopharma, Radiopharmacies Division).

The primary topic of discussion at this year’s visit was the Unlawful Compounding of Radiopharmaceuticals. It is the position of NANP that drug manufacturers have developed and obtained FDA approval for radiopharmaceuticals currently used in nuclear medicine procedures to diagnose, monitor and/or treat cancer, cardiovascular disease, dementia, infection, and many other diseases and conditions. However, it is believed that certain nuclear manufacturers are preparing essentially unapproved copies of these FDA-approved and commercially available products under the guise of nuclear pharmacy practice by becoming licensed as “compounding pharmacies”. These products are now available as lower cost alternatives to the commercially available, approved products, and are being shipped nationwide. The FDA has not approved this process and during the discussion it was noted that this practice could potentially put the facilities that use these copies as well as the prescribing physicians, administering nuclear technologists, and, most important, the patients at risk. (Read more about Jubilant Radiopharma, Radiopharmacies Division's policy to procure and supply FDA-approved radiopharmaceutical products exclusively from FDA-approved cGMP compliant manufacturers here.)

Over the course of two days and more than 20 meetings, our group met with congressmen, deputy chiefs of staff, legislative assistants, and healthcare policy advisors. These individuals are chosen by NANP based on their influence, geography and background. Our “ask” of these key members was for Congress to require the FDA to use its enforcement authority to stop the practices of rogue and illegal nuclear manufacturers that are hiding behind nuclear pharmacy compounding licensure that distribute essentially copies of FDA-approved drugs. A few examples of representatives and advisors we met with include Congressmen Brett Guthrie and Earl (Buddy) Carter, and Health Care Policy Advisor Scott Raab. Rep. Guthrie of Kentucky serves as vice chair on the Subcommittee for Energy and Commerce with jurisdiction over our nation’s energy, healthcare, telecommunications and consumer product safety policies — and represents the constituents who receive the radiopharmaceuticals dispensed by Tim Quinton, owner of Radiopharmacy, Inc. We also met with Rep. Carter, who is not only the congressman for my district in Georgia, but is also the only pharmacist on Capitol Hill. His interpretation of pharmacy law and influence may have lasting effects on our industry. But the highlight of the week for me came near the end of the second day when we met with Scott Raab, the healthcare policy advisor in the Office of U.S. Senate Majority Leader Mitch McConnell. It was truly a humbling experience to be in the Capitol Building, shoulder to shoulder with our industry colleagues, discussing policies that affect 30,000 patients per day in this country with our government representatives. During the middle of our meeting with Raab, we had to pause for a moment as we looked out the window. In the distant background of Pennsylvania Avenue that stretches from the Capitol to the Washington Monument, Marine One (the helicopter that carries the President of the United States) was landing on the South Lawn of the White House. To witness that, as I sat in one of the highest offices in this great nation, was truly spectacular. It is a memory that I will carry with me for the rest of my life.

A special note of thanks to the Jubilant Radiopharma, Radiopharmacies Division's – Savannah Pharmacy Team Members, especially pharmacists Billy Thurmon and Paul Bright, and Technician II Kristine Furr, for their extra work while I was away attending the NANP legislative event!