Obama wants FDA to work on drug shortages
President Barack Obama recently called on the U.S. Food and Drug Administration to make efforts to reduce drug shortages in pharmacies and healthcare facilities, as more patients have limited access to vital medications and drug companies face the possibility of price increases.
Shortages of cancer drugs, anesthetics, drugs for emergency medicine, electrolytes for intravenous feedings and other medications have been blamed for patient deaths, The Associated Press reports. Because there is not enough supply, hospitals and healthcare facilities are being forced to purchase drugs from secondary suppliers at escalated prices, and many healthcare systems are delaying surgeries and cancer treatments until their stocks can be replenished.
In response to the shortages, Obama recently signed an executive order directing the FDA to take steps to solve the low supply of drugs available to healthcare providers. The president is also supporting new legislation in both the House and Senate that would require drug makers to notify the FDA six months prior to a potential drug shortage, so the agency can properly prepare facilities across the country. Currently, the FDA only requires makers to tell the agency when a drug is being discontinued, the news source reported, which is voluntary.
In 2010, the FDA reported 178 drug shortages and has continued to see low supplies increase throughout 2011. The news source reported drug shortages are typically caused by quality or manufacturing problems, as well as delays in receiving components from suppliers.
Drug makers will also discontinue a medication when a newer version becomes available and is more profitable, often leaving many healthcare facilities lacking adequate supplies, as the U.S. government cannot force a drug maker to continue to make a drug.
MSNBC reported the executive order will also require the FDA to give the U.S. Justice Department fair warning about possible price gouging. Federal lawmakers explained that there is a "gray market" for drugs that exploits the shortage situation by selling medications that are in high demand and short supply at hundred-fold mark-ups. This is costing the healthcare system valuable money.
A press release from The White House said the executive order is one of a series of steps to help address the shortage issue. Obama also plans to send a letter to drug manufacturers reminding them of their legal obligation to report when drugs are being discontinued to the FDA, as well as notify the federal agency of any potential shortages in the near future.
The president will increase staff and resources available to the FDA's Drug Shortages Program to help manage the expected increased workload that will result from the new requirement for early notifications by drug makers.
Finally, the U.S. Departmenf of Health and Human Services Office will release a report that assesses the underlying factors that lead to drug shortages to best prevent them from happening in the future. The FDA will also be required to compose a report outlining its role in monitoring, preventing and responding to shortages.
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