The U.S. Food and Drug Administration (FDA) Tuesday approved new suppliers for two crucial cancer drugs. The move was to ease the shortage of the drugs.
One of them will be imported and the FDA is approving new manufacturer to make the second.
The FDA said that it would temporarily import, Lipodox, a replacement drug for Doxil, a drug for ovarian and other cancers.
Doxil, a cancer drug marketed by Johnson & Johnson in the U.S., is in short supply due to manufacturing problems. Around 7,000 patients used the drug in the United States before Johnson & Johnson announced in January that it was able to supply the drug to 4,400 patients only.
There is a temporary arrangement made by the FDA to import Lipodox from Indian drug maker Sun Pharmaceutical Industries Ltd and its distribution subsidiary, Caraco Pharmaceutical Laboratories Ltd.
The FDA has approved APP Pharmaceuticals for the supply of a preservative-free version of Methotrexate, a crucial drug for children with a type of leukemia called 'ALL', and for high-dose treatment of bone cancer.
We believe we can meet the needs of patients on a continuing basis ... This should resolve the shortages, FDA Commissioner Margaret Hamburg was quoted as saying by Reuters:
FDA officials said that a number of industry factors, including consolidation of generic drug makers and manufacturing problems, had contributed to the shortages of medicines.
Patient advocates and doctors were also speaking at the FDA's conference. They saw these efforts of the FDA as positive sign but were angry because their children are at high risk due to shortage of drugs.
Dr. Peter Adamson, chair of the Children's Oncology Group, insisted that the government should pass legislation that could help address the issue of shortages. Presently, there is a law where companies only have to tell the agency that they are stopping supply when they are the only maker of a drug.
The FDA says the company can shut down their units when their profit margins erode too far.