FDA Plans to Eliminate Shortages of 2 Cancer Drugs

The U. S. Food and Drug Administration announced Tuesday what it called a series of steps to ensure the continued availability of vital cancer medicines that have experienced dangerously short supply. Among the drugs, methotrexate, is utilized in mixture with other drugs to combat — and in many cases cure — acute lymphoblastic leukemia (ALL), the most common type of cancer in children. It typically strikes kids aged 2 to 5.And another drug, Lipodox, will end up being temporarily imported from a pharmaceutical organization in India to help 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 simply no generic variations of Doxil.”Through the collaborative work of [the] FDA, market and other stakeholders, sufferers and families waiting for these products or anxious about their availability should right now be capable of geting the medication they want,” FDA Commissioner Dr. Margaret A. Hamburg stated in a news discharge. The FDA also stated it was 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 medication shortage or supply disruption. Methotrexate is a cornerstone in the treatment of children with severe lymphoblastic leukemia. In high doses, the generic medication has prevailed in curing individuals and beneficial in preventing recurrence. Without the medication, a patient’s chance for a cure is reduced while the risk of recurrence rises, oncologists said. Some cancer doctors had warned the other day that items of methotrexate could be exhausted inside a fortnight. To offset the shortage of methotrexate, the FDA said Tuesday that it has worked with several drug producers to help maintain items to meet up all patient requirements. Preservative-free methotrexate is necessary for the intrathecal (injection in to the fluid surrounding the mind and spinal cord) treatment of children with ALL, the company said. The FDA stated the steps used with methotrexate included approving a preservative-free edition of the generic medication manufactured by APP Pharmaceuticals, of Schaumburg, Ill. Those supplies should become available in March and continue indefinitely, the agency said. Second, Illinois-based Hospira Inc., which currently manufactures methotrexate, has increased additional supplies, generating 31,000 new vials of the drug — enough for several month’s supply. Those extra vials are being shipped Tuesday to hundreds of U. S. hospitals and treatment centers, the FDA stated. The FDA also noted that it continues to utilize other producers of methotrexate which have also stepped up production. Those producers consist of Mylan Inc., of Canonsburg, Pa., and Sandoz US Inc., of Princeton, N. J. At a midday information conference Tuesday, one of the loudspeakers was Sara Stuckey, mom of 6-year-previous Nate Stuckey, who has been on methotrexate since he was identified as having ALL in ’09 2009. “It is hard enough to listen to your son or daughter has cancer, but to listen to that the treatment that’s successfully working is abruptly unavailable is devastating,” she stated. “My husband and I pray the recommended medicines to fight his cancer will be available if it is time for Nate’s next treatment. And we wish that later on no more families have to go through the tension of wondering whether confirmed, lifesaving treatments will become out of reach if they need it the most.”Speaking in the news meeting, Hamburg said: “There are way too many families like the Stuckeys who worry they won’t have the medication they need for his or her next treatment and are understandably anxious about switching to a medication that may have significantly more side results or may be less effective. Obviously this is not appropriate.” “We are making progress,” Hamburg added. “There have been 195 medication shortages prevented in 2011 and 114 medication shortages prevented since October 2011 when we made the call for early notification” of potential shortages. As for the ovarian cancer medication Lipodox, the FDA said it’ll allow the temporary importation of the medication made by Sun Pharma Global FZE. The company said in its information release that “short-term importation of unapproved foreign drugs is known as only in rare circumstances when there exists a shortage of an authorized drug that’s critical to individuals and the shortage cannot be resolved in a timely fashion with FDA-approved medicines.” The shortages of methotrexate and Doxil are simply the latest in a series of drug shortages that have existed for several years. In 2011, prescription drug shortages in the United States hit an all-time high. Last fall, some 200 drug shortages have been reported, in comparison to 178 in all of 2010, the FDA reported. Most of the scarce medications are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as cancer. Some are only given in hospitals and are “absolutely important,” Valerie Jensen, associate director of the FDA’s medication shortage program, said during a news conference last September. Over fifty percent (54 percent) of shortages in 2010 2010 were due to quality problems, such as medication impurities. Some were caused by delays or manufacturing capacity problems, while 11 percent were caused by discontinuation of a drug and 5 percent resulted from raw materials shortages, Jensen said. Jensen also said the shortages tend to occur in drugs that aren’t “economically attractive.” This may mean that only one company produces the drug, making it harder to find alternatives if the supply dries up. Most of the problems are linked with generic drugs, health specialists explained, because few manufacturers make them and profit margins aren’t as high for brand-name drugs still under patent protection. On Oct. 31, 2011, President Barack Obama signed an executive purchase designed to help relieve the drug shortages. The purchase directed the FDA to “take action” to avoid and reduce worsening prescription medication shortages. In response to Tuesday’s announcement, Dr. Armand Keating, president of the American Society of Hematology (ASH), said in a declaration: “ASH is encouraged by the methods FDA is acquiring to ease drug shortages that have significantly affected so many patients with hematololgic malignancies under our associates’ care. The measures announced today are consistent with the Society’s recommendations to FDA, Congress and the Obama Administration to increase the agency’s authority to prevent medication shortages by requiring manufacturers to provide early notification of impending shortages and importing drugs in critical supply.”
“While ASH applauds the precise actions announced today,” Keating added, “we also understand that these measures represent only some of a remedy to a much larger problem. In addition to these steps, extra measures — such as developing a national drug registry and providing economic incentives to producers to produce a steady supply of generics — should be implemented to permanently prevent shortages. Until a full solution is set up, treatment will be delayed and treatment will be rationed for critically ill individuals.”