Presidents Executive Order Attempts to Alleviate Drug Shortages

ABC News has recently reported on the divided sentiment concerning President Obama’s executive order to reduce a dangerous shortage of life-saving medications. While supporters of President Obama’s actions believe this is an essential step to alleviate these shortages, opponents claim “the order is not enough to stop price gouging by some pharmaceutical companies.” ABC reports that the drugs most affected by the shortage are “essential cancer drugs.” The article goes on to explain that “hospitals have reported the worst shortage in nearly a decade of chemotherapy agents like doxorubicin.” Chemotherapy is often given as a primary treatment for patients diagnosed with mesothelioma. Furthermore, the earlier mesothelioma is treated, the more likely it is patients will see encouraging results. Furthermore, many patients turn to a multimodal treatment approach, which is a combination of traditional methods like surgery, chemotherapy, and radiation. Patients who undergo a combination of several different treatments often enjoy increased survival rates and a greater life expectancy. However, because various chemotherapy agents comprise the drug shortage reported by ABC News, many mesothelioma patients may be significantly impacted. This is especially troubling for mesothelioma patients who depend on a prompt diagnosis and swiftly-implemented treatment regimen in order to have the strongest prognosis possible. Obama’s order will require the U.S. Food and Drug Administration to “broaden reporting of potential drug shortages, expedite regulatory reviews that can help prevent shortages, and examine whether potential shortages have led to price gouging. The drug shortage has compromised or delayed care for some patients and may have led to otherwise preventable deaths,” ABC reports. One proponent of the President’s order is the American Cancer Society’s President of the Cancer Action Network, Christopher W. Hansen. Hansen was quoted in ABC’s article, stating  that “[The order would] allow government , industry, providers and the public to more systematically analyze and understand the causes of specific drug shortages as they occur, and to develop real-time solutions that are also needed to address the acute problems that cancer patients live with daily.” In the ABC article, President Obama commented on his reasons for signing the order, noting that “sometimes we run out of or are low on certain types of drugs, and that drives up the prices and increases patient risk.” Unfortunately, despite the order, ABC News reports that shortage issues could continue. ABC interviewed Dr. Sidney Wolfe of the public watchdog group, the Public Citizen, who said that “these new orders may be difficult to implement since manufacturing companies have little incentive to do so.” Wolfe continued by explaining that the price gouging could continue “unless there are large financial penalties for companies failing to report anticipated shortages to the FDA.” According to ABC News, the President’s orders will require the FDA to add six people to the five who are assigned to its drug shortage program. The agency will also be required to add two staff members to its Center for Evaluation and Research. Although these orders are a step in the right direction, the problem of drug shortages in America has hardly been solved.  According to the article, “Twenty-one out of 23 medical centers surveyed by ABC News’ Medical Unit say they still have significant drug shortage problems.” However, FDA Commissioner, Peggy Hamburg, remained hopeful during a press conference prior to the president’s signing. ABC News quoted Hamburg as explaining that, “Obviously, this will put new additional pressures on the FDA in terms of personnel and time demands and financial demands,” further going on to explain that “We will not be able to prevent all future shortages and fully remediate in the near term the existing shortages, but we can make a difference by expanding our net of early warnings and getting in there before the shortage occurs.” Currently, the FDA has prevented 137 shortages in the last year and a half, but 178 drugs are still in short supply, ABC News reports. With 2,000 to 3,000 new mesothelioma patients diagnosed each year, it is uncertain how these individuals will be affected by the drug shortages.
Reference:
  • Sakahi, Lara. (October 31, 2011) “Obama Issues Executive Order to Ease Drug Shortages.” Retrieved on November 8, 2011 from ABC News.
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