FDA Fights Against Shortage of Significant Cancer Drugs

The U. S. Food and Drug Administration announced Tuesday what it called a number of steps to ensure the continued option of vital cancer medicines that have been in dangerously short supply. One of the drugs, methotrexate, is utilized in mixture with other medicines to combat — and perhaps cure — acute lymphoblastic leukemia (ALL), the most common type of cancer in children. It typically strikes kids aged 2 to 5.And another medication, Lipodox, will become temporarily imported from a pharmaceutical firm in India to ease a shortage of the chemotherapy medication Doxil (doxorubicin), which is utilized to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma. Lipodox is comparable in chemical make-up to Doxil; there are no generic variations of Doxil.”Through the collaborative work of [the] FDA, sector and other stakeholders, individuals and families looking forward to these products or anxious about their availability should now be able to get the medication they want,” FDA Commissioner Dr. Margaret A. Hamburg said in a news release. The FDA also said it had been issuing recommendations to the drug industry that spell out comprehensive requirements for “both mandatory and voluntary notifications” to the company of potential problems that could result in a drug shortage or supply disruption. Methotrexate is a cornerstone in the treatment of children with acute lymphoblastic leukemia. In high doses, the generic drug has been successful in curing individuals and beneficial in avoiding recurrence. Without the medication, a patient’s chance for a remedy is reduced as the risk of recurrence rises, oncologists stated. Some cancer doctors had warned last week that materials of methotrexate could possibly be exhausted inside a fortnight. To offset the shortage of methotrexate, the FDA said Tuesday that it spent some time working with several drug producers to help maintain products to meet up all patient requirements. Preservative-free methotrexate is needed for the intrathecal (injection into the fluid surrounding the brain and spinal-cord) treatment of kids with ALL, the agency said. The FDA stated the steps taken with methotrexate included approving a preservative-free version of the generic drug manufactured by APP Pharmaceuticals, of Schaumburg, Ill. Those supplies should become obtainable in March and continue indefinitely, the agency said. Second, Illinois-based Hospira Inc., which already manufactures methotrexate, has sped up additional supplies, making 31,000 new vials of the drug — enough for several month’s supply. Those extra vials are being delivered Tuesday to hundreds of U. S. hospitals and centers, the FDA stated. The FDA also noted that it continues to utilize other manufacturers of methotrexate that have also stepped up production. Those manufacturers consist of Mylan Inc., of Canonsburg, Pa., and Sandoz US Inc., of Princeton, N. J. At a midday information conference Tuesday, among the audio speakers was Sara Stuckey, mother of 6-year-outdated Nate Stuckey, who has been on methotrexate since he was identified as having ALL in 2009 2009. “It really is hard enough to listen to your child has cancer, but to hear that the treatment that is successfully working is abruptly not available is devastating,” she said. “My husband and I pray the recommended medications to fight his cancer will be available if it is time for Nate’s following treatment. And we wish that in the future no more families need to go through the tension of wondering whether proved, lifesaving treatments will be out of reach when they need it the the majority of.”Speaking in the news conference, Hamburg said: “There are way too many families just like the Stuckeys who worry they don’t have the medicine they need because of their next treatment and so are understandably anxious about switching to a medication that may have more side results or may be less effective. Clearly this is not suitable.” “We are making improvement,” Hamburg added. “There have been 195 medication shortages prevented in 2011 and 114 drug shortages prevented since October 2011 whenever we made the decision for early notification” of potential shortages. For the ovarian cancer medication Lipodox, the FDA said it will allow the temporary importation of the drug made by Sun Pharma Global FZE. The company said in its information release that “temporary importation of unapproved foreign drugs is considered only in rare circumstances when there exists a shortage of an approved drug that’s critical to sufferers and the shortage can’t be resolved in due time with FDA-approved medications.” The shortages of methotrexate and Doxil are just the latest in some drug shortages that have existed for several years. In 2011, prescription medication shortages in the usa hit an all-period high. Last fall, some 200 drug shortages had been reported, compared to 178 in all of 2010, the FDA reported. Many of the scarce drugs are injectables, such as cytarabine and cisplatin, used to take care of serious conditions such as cancer. Some are only given in hospitals and so are “absolutely crucial,” Valerie Jensen, associate director of the FDA’s medication shortage program, said during a news conference last September. More than half (54 percent) of shortages this year 2010 were because of quality issues, such as medication impurities. Some were caused by delays or manufacturing capacity complications, while 11 percent were due to discontinuation of a medication and 5 percent resulted from raw material shortages, Jensen said. Jensen also said the shortages have a tendency to occur in medicines that are not “economically attractive.” This may mean that only one company produces the medication, making it harder to discover alternatives if the supply dries up. Most of the problems are linked with generic drugs, health professionals explained, because few manufacturers make them and income aren’t as high for brand-name medicines still under patent security. On Oct. 31, 2011, President Barack Obama signed an executive order designed to help ease the drug shortages. The purchase directed the FDA to “do something” to prevent and decrease worsening prescription drug shortages. In response to Tuesday’s announcement, Dr. Armand Keating, president of the American Society of Hematology (ASH), stated in a statement: “ASH is encouraged by the methods FDA is taking to ease drug shortages that have significantly affected so many patients with hematololgic malignancies under our users’ care. The actions announced today are consistent with the Society’s recommendations to FDA, Congress and the NATIONAL GOVERNMENT to broaden the agency’s authority to avoid drug shortages by requiring manufacturers to provide early notification of impending shortages and importing drugs in critical supply.”
“While ASH applauds the specific actions announced today,” Keating added, “we also recognize that these measures represent only some of a solution to a much larger problem. Furthermore to these steps, extra measures — such as developing a national medication registry and providing economic incentives to producers to produce a steady supply of generics — must be implemented to permanently prevent shortages. Until a total solution is in place, treatment will become delayed and care will become rationed for critically ill patients.”