Introduction

On average, more than 3 million people suffer from anemia in the United States. Anemia is a condition when you have less than the normal number of red blood cells in your blood or when the red blood cells in your blood don’t have enough hemoglobin. Hemoglobin is a protein. It gives the red color to your blood. Its main job is to carry oxygen from your lungs to all parts of your body. If you have anemia, your blood does not carry enough oxygen to all the parts of your body. Without oxygen, your organs and tissues cannot work as well as they should. Women and people with chronic diseases are at the greatest risk for anemia.

Background

Peginesatide, trade name Omontys, developed by Affymax and Takeda, is an erythropoietic agent, a functional analog of erythropoietin. It is approved by the US Food and Drug Administration for treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. On February 23, 2013, Affymax and Takeda issued a press release indicating that they were recalling all batches of peginesatide from the market. The recall issued was due to 17 people having severe allergic reactions with some kidney-disease patients requiring immediate medical help and five patients reportedly dying due to the medicine. Due to the voluntary drug recall, there is now a drug shortage of Omintys. Patients that have no allergic reaction to Omintys cannot receive the medicine.

Issue

Should a manufacturer be required to report a drug shortage?

Rule

Manufacturers should report shortages if:

  1. There are no other alternatives for the medicine they need
  2. It directly affects patients

Analysis

No Alternative Medicine

According to the FDA, the number of drug shortages has increased by nearly 300% since 2005. More than half of the drugs on the shortage list are considered critical, meaning they have no alternative. The FDA closely works with manufacturers of drugs in short supply to communicate the issue and to help restore availability. The FDA also works with other firms who manufacturer the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage.

Directly Affects Patients

Patients are directly affected by these shortages. Such is the case with Renee Mosier who was diagnosed with ovarian cancer. After numerous failed surgeries, her doctor was unable to get Doxil due to a drug shortage. Here, the shortage directly affected Mosier and she passed away. Having no other alternatives to the Doxil medicine, the makers should have informed the FDA in advance so the process could be better handled.

Conclusion

Manufacturers should report shortages because they directly affect consumers, and in many cases there are no alternative medications.

For more information on this issue, contact the Kulkarni Law Firm.