The U.S. Government Accountability Office (GAO) released a report on December 15, 2011 in which it stated that the U.S. Congress should consider requiring drug manufacturers to report to the U.S. Food and Drug Administration (FDA) any changes that could affect their supply of their drugs. The GAO further suggested that the FDA enhance its ability to respond to drug shortages that are getting worse.
The GAO reported that drug shortages have increased each year from 2006 through 2010, with a record number of drug shortages in 2010 and the pace of drug shortages in 2011 that is expected to surpass 2010. There were a total of 1,190 drug shortages reported from January 1, 2001 through June 20, 2011, and 65% of the shortages involved drugs that were in short supply more than once. The average drug shortage lasts more than 9 months (286 days).
More than half of the recent drug shortages have involved critical shortages of generic injectible drugs. Anesthetic drugs, oncology (cancer) drugs, and anti-infective drugs were most often among those drugs in short supply (imagine not being able to obtain the first-choice cancer drug for your cancer simply because there is a shortage of the drug).
During the first six months of 2011, the FDA was able to prevent 50 potential drug shortages when it has been advised by manufacturers and suppliers of the possibility of a shortage. The FDA has been unable to do more to respond to possible drug shortages due, in part, to its lack of authority to require that drug manufacturers report to the FDA actual or potential drug shortages and its lack of authority to prevent or resolve drug shortages. Nonetheless, the FDA shares fault in its response to drug shortages because the FDA does not adequately gather and evaluate information regarding drug shortages that would enable the FDA to monitor the trends in drug shortages or to address the underlying causes of drug shortages. The GAO found that the FDA has failed to provide sufficient resources to manage its responses to drug shortages or to measure and prioritize its responses to drug shortages.
It appears from the GAO’s report that both Congress and the FDA need to step up to the plate, and quickly, so that the FDA has the authority, ability, resources, and mandate to systematically address the various issues involving the on-going and worsening problem of drug shortages in the United States.
We at MedicalMalpracticeLawyers.com usually blog about issues directly related to medical malpractice claims, medical malpractice cases, medical malpractice attorneys, etc., but when we read the GAO’s report about the continuing and worsening drug shortages, we feared that lives are being disrupted or destroyed because of the limited availability or unavailability of critical drugs used in hospitals and by health care providers. A concerted and intensive effort by our governmental authorities to address and resolve the drug shortage problem in the United States before another day passes is necessary for the public to be protected, which is the number one priority of any national government.
If you or a loved one have been injured as a result of a drug issue, wrongful actions (or lack of action) by a negligent health care provider, or a medical malpractice event caused by a medical care provider, you should seek the prompt assistance of a medical malpractice lawyer to answer your questions, investigate your medical malpractice claim, and represent you in your medical malpractice case, if appropriate.
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