New Pharmaceutical Project of FDA Can Reduce Shortages of 2 Cancer Drugs


The U. S. Food and Medication Administration announced Tuesday what it called a series of steps to ensure the continued availability of vital cancer drugs that have experienced dangerously short supply. Among the drugs, methotrexate, is used in mixture with other medicines to combat — and in many cases cure — severe lymphoblastic leukemia (ALL), the most typical type of cancer in children. It typically strikes children aged 2 to 5.And another medication, Lipodox, will become temporarily imported from a pharmaceutical organization in India to help ease a shortage of the chemotherapy drug Doxil (doxorubicin), which can be used to treat ovarian malignancy, 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, patients and families looking forward to the products or anxious about their availability should at this point be capable of geting the medication they need,” FDA Commissioner Dr. Margaret A. Hamburg said in a news release. The FDA also said it had been issuing suggestions to the drug market that spell out comprehensive requirements for “both mandatory and voluntary notifications” to the agency of potential problems that could result in a drug shortage or supply disruption. Methotrexate is a cornerstone in the treatment of children with severe lymphoblastic leukemia. In high doses, the generic drug has prevailed in curing sufferers and beneficial in stopping recurrence. Without the drug, 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 possibly be exhausted within two weeks. To offset the shortage of methotrexate, the FDA said Tuesday that it spent some time working with several drug producers to help maintain materials 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 kids with ALL, the agency said. The FDA said the steps taken with methotrexate included approving a preservative-free edition of the generic drug manufactured by APP Pharmaceuticals, of Schaumburg, Ill. Those materials should become obtainable in March and continue indefinitely, the agency said. Second, Illinois-based Hospira Inc., which currently manufactures methotrexate, has sped up additional supplies, producing 31,000 new vials of the medication — enough for more than one month’s supply. Those extra vials are being delivered Tuesday to hundreds of U. S. hospitals and treatment centers, the FDA stated. The FDA also noted that it continues to utilize other manufacturers of methotrexate that have also stepped up production. Those producers include Mylan Inc., of Canonsburg, Pa., and Sandoz US Inc., of Princeton, N. J. At a midday information conference Tuesday, among the speakers was Sara Stuckey, mom of 6-year-outdated Nate Stuckey, who offers been on methotrexate since he was identified as having ALL in ’09 2009. “It is hard enough to hear your son or daughter has cancer, but to listen to that the treatment that’s successfully working is instantly unavailable is devastating,” she stated. “My husband and I pray the recommended medications 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 need to go through the stress of wondering whether proven, lifesaving treatments will end up being out of reach if they need it the most.”Speaking in the news meeting, Hamburg said: “There are way too many families just like the Stuckeys who get worried they don’t have the medication they need for his or her next treatment and are understandably anxious about switching to a medicine that may have more side results or could be less effective. Obviously this is not suitable.” “We are making improvement,” Hamburg added. “There have been 195 drug shortages prevented in 2011 and 114 drug shortages avoided since October 2011 whenever we made the call for early notification” of potential shortages. For the ovarian cancer drug Lipodox, the FDA said it will allow the temporary importation of the medication made by Sun Pharma Global FZE. The agency said in its information release that “short-term importation of unapproved international drugs is known as only in rare circumstances when there exists a shortage of an authorized drug that is critical to patients and the shortage can’t 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 medication shortages in the usa hit an all-time high. Last fall, some 200 drug shortages had been reported, in comparison to 178 in every of 2010, the FDA reported. Most of the scarce medicines are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as for example cancer. Some are only provided in hospitals and so are “absolutely vital,” Valerie Jensen, associate director of the FDA’s drug shortage program, said during a news meeting last September. More than half (54 percent) of shortages in 2010 2010 were because of quality issues, such as medication impurities. Some were due to delays or manufacturing capacity problems, while 11 percent were due to discontinuation of a drug and 5 percent resulted from raw material shortages, Jensen stated. Jensen also said the shortages tend to occur in medications that are not “economically attractive.” This could mean that only one company produces the medication, which makes it harder to find alternatives if the supply dries up. Most of the problems are tied to generic drugs, health specialists explained, because few manufacturers make them and income aren’t as high as for brand-name medicines still under patent protection. On Oct. 31, 2011, President Barack Obama signed an executive order designed to help ease the drug shortages. The purchase directed the FDA to “take action” to avoid and decrease worsening prescription drug shortages. In response to Tuesday’s announcement, Dr. Armand Keating, president of the American Culture of Hematology (ASH), stated in a statement: “ASH is encouraged by the methods FDA is acquiring to alleviate drug shortages that have significantly affected so many individuals with hematololgic malignancies under our people’ care. The procedures announced today are consistent with the Society’s suggestions to FDA, Congress and the NATIONAL GOVERNMENT to increase the agency’s authority to avoid drug shortages by requiring manufacturers to supply early notification of impending shortages and importing drugs in critical supply.”
“While ASH applauds the specific actions announced today,” Keating added, “we also realize that these measures represent only some of a remedy to a much bigger problem. In addition to these steps, additional measures — such as for example developing a national drug registry and providing economic incentives to producers to produce a steady supply of generics — must be implemented to permanently prevent shortages. Until a comprehensive solution is in place, treatment will be delayed and care will become rationed for critically ill individuals.”