Editor’s note: This op-ed is by Monica Neufang, business unit communication leader, Global Pharmaceutical Communications, on behalf of Janssen Products, LP.
The Oct. 24 article by Terry Allen (VTDigger.org), “Drug shortage puts patients at risk in Vermont,” reports that Ondis Eardensohn has been unable to access our product DOXIL® (doxorubicin HCl liposome injection), a critical therapy for patients with certain types of cancer. We deeply regret the circumstances causing the recent shortage of DOXIL, impacting Ms. Eardensohn and others. We want to be sure that your readers have the most updated and accurate information on the reasons for this shortage and what we’re doing about it.
While there are a variety of factors causing drug shortages nationwide in many different disease areas, the DOXIL shortage is due to the inability of our supplier to make the medication. The main cause is related to equipment failures. Equipment failures require investigation and repair, sometimes resulting in the shut-down of entire production lines, which is the case for DOXIL. While we work with our supplier to resolve production issues, DOXIL will be intermittently available during the next several months. We recognize this is a challenging situation and are committed to continuing to work with our supplier to ensure that as new and limited supply of DOXIL becomes available, it is quickly made available to patients next on the waiting list through the DOXIL Creating Awareness & Reinforcing Education Support (C.A.R.E.S.) Physician Access Program.
We alerted the U.S. Food and Drug Administration (FDA) and the healthcare community in June when we first determined that DOXIL might be in short supply in the next few weeks. When we learned the shortage would be longer term, we quickly alerted healthcare professionals and directed them not to start new patients on DOXIL. We began working on a process to allocate the limited supply of medicine as it becomes available during the shortage to patients and their healthcare providers through the DOXIL C.A.R.E.S. Physician Access Program, information available at www.DOXIL.com.
At the time we spoke with Ms. Allen in August, we were in the process of launching this program and were not able to provide the number of patients who would receive the available DOXIL supply based on their physicians’ submission of enrollment applications. Approximately 2,000 patients have been able to receive DOXIL through this program, with approximately 2,500 patients on the wait list. Importantly, we have provided and will continue to provide regular updates to the FDA on the progress of the allocation program and the DOXIL supply situation.
As additional, limited supplies of DOXIL become available to patients in the program, we will continue to inform the patient community, healthcare professionals, the FDA and advocacy and professional organizations, posting updates on our website. Our most recent communication was on Oct. 14. Because this limited supply was not sufficient for all patients on the wait list, we will continue to maintain the allocation program until DOXILis fully available on a consistent, reliable basis.
There are no quality issues associated with the DOXIL supply in the marketplace. Ms. Allen’s statement that the DOXIL supply shortage is related to other Johnson & Johnson manufacturing situations is erroneous. The items noted by Ms. Allen are related to a consumer business unit making very different products under very different circumstances.
As to a grey market for DOXIL, we have not learned of any instances in which anyone has been able to purchase DOXIL via websites or other channels. We closed the distribution network in early August by implementing the DOXIL C.A.R.E.S. Physician Allocation Program. DOXIL is distributed only through the network of company-approved specialty distributors and wholesalers. Controls are in place to ensure only enrolled and approved DOXIL C.A.R.E.S. Physician Access Program patients receive DOXIL via these authorized distribution channels. In addition, measures were instituted to prevent hoarding and price gouging, which reports have noted can be experienced during some drug supply shortages.
Finally, the DOXIL shortage is not driven by profit motive. As a healthcare organization focused on improving the lives of patients with cancer, we are deeply committed to restoring the availability of DOXIL for patients who await treatment and will not be satisfied until we can announce full supply of DOXIL is available on a reliable, consistent basis for every patient whose physician has prescribed this medicine as part of the treatment regimen.
