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article imageObama acts over scarce supplies of childrens’ cancer drug

By Tim Sandle     Feb 23, 2012 in Health
Washington - Following reports, including in Digital Journal, on the shortage of life-saving drugs such as those required to combat cancer, the FDA, under orders from President Obama, have outlined a plan to increase supplies.
The Digital Journal reported that the U.S. Senate and medical groups had raised concerns about a national shortage of a scarce cancer drug for children. The scarcity related to the volume of medicine being prepared by pharmaceutical companies
Such concerns elicited an urgent response from the White House and consequently the U.S. Food and Drug Administration, a government agency, has announced a series of steps designed to increase the supply of critically needed cancer drugs and to put in place preventative measures to guard against future drug shortages.
In light of this, FDA Commissioner Margaret A. Hamburg, M.D. is quoted by Pharmaceutical Online as saying:
"A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration. Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need."
One of the drugs covered by the FDA plan is methotrexate, which is used to treat a common childhood cancer called acute lymphoblastic leukemia. The supply problems arose due to the main production facility – Ben Venue – being closed over hygiene concerns. The New York Times recently reported that shortages of the drug were putting children at risk. The FDA has sourced a new manufacturer of the drug (APP Pharmaceuticals) and has taken steps to speed up the licensing application. The product is expected to become available in March 2012.
The moves have come about due to President Obama issuing an Executive Order on prescription drug supply shortages. From this the FDA have issued guidance for drug companies which requests that the companies tell the FDA when supplies are running low.
Unfortunately the guidance is not compulsory and Big Pharma do not have to inform the public when supplies are running low. The FDA state with this regard:
“Manufacturers are not required to report information, such as reasons for shortages or the expected duration of shortages. However, many companies voluntarily provide shortage information that FDA posts on its website. FDA encourages and appreciates all reporting of shortages by manufacturers.”
Time will tell if these actions are sufficient.
More about Cancer, Leukemia, Drugs, Fda, Big pharma
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