The severe shortages of drugs in the United States are becoming more and more ominous. Hospitals and surgeons alike are finding that the drugs they use and rely on may be available one day but unavailable the next. Some unscrupulous drug middlemen are buying up supplies of drugs and then jacking up the prices simply because they can. Some physicians are changing their patients’ long-term drugs that are in short supply to other drugs that are presently available but may be less efficacious for their patients’ conditions. Patients undergoing surgical procedures may be given different medications with side effects or limitations because the typical surgical drugs are not presently available. The drug shortage in the U.S. is both serious and dangerous.
One category of drugs that is presently a major concern for ongoing and severe shortages is sterile injectable drugs (often referred to as “sterile injectables”) that are injected into patients and can cause immediate and life-threatening conditions if they are manufactured, packaged, or stored incorrectly or if they contain contaminants that can adversely affect the patients into whom they are injected — many of the patients who receive the sterile injectables are among the most sick or debilitated patients.
The FDA has reported that the top three generic injectable manufacturers hold 71% of the market by volume — if one or more of them have any manufacturing problems ranging from raw material supply shortages to unsafe manufacturing facilities or procedures to contaminants in the finished products, the health and well-being of U.S. citizens are placed at serious risk due to the shortage or unavailability of the critical injectable products.
The FDA also reported that most sterile injectables have one manufacturer that produces at least 90% of the drug — therefore, if the manufacturer encounters any problems that affect production of its sterile injectables, the entire market for those sterile injectables is at extreme risk.
The FDA is also concerned that the drug manufacturers are using “just in time” manufacturing and inventorying practices that leave little margin for error — if they encounter any problems with producing their drugs or with their inventory of products, there is no supply cushion that will ease the effects of the problems until additional drug products can be manufactured and provided.
The manufacture of sterile injectable drugs requires complex and difficult manufacturing and marketing features that make their shortages more likely to occur and harder to prevent or mitigate — they often require dedicated manufacturing lines and unique manufacturing efforts. Manufacturing problems have resulted in glass shards, metal filings, fungus, or other contaminants being found in sterile injectable drugs that have contributed to their shortages.
Drug shortages have become such a serious problem in the United States that on October 31, 2011, President Obama issued an Executive Order directing the FDA and the Department of Justice to take further action to reduce and prevent drug shortages, to protect consumers, and to prevent price gouging ( for example, one report found that a leukemia drug that typically sells for $12 per vial was being sold for $990 per vial on the “grey market”; and another drug used to treat high blood pressure that had been priced at $25.90 had increased to $1,200 due to its shortage — the typical grey market seller marks up the price by 650%).
Drugs are life. Any person or company that intentionally and unjustifiably raises the prices of necessary drugs for greedy or illegal purposes should be fully investigated and punished to the fullest extent of the law. Their names should be made public and their wrongful actions fully disclosed to the entire country.
If a drug given to you caused you to be injured or suffer other substantial harm, or if a “bad drug” resulted in death or permanent injuries, the drug manufacturer or supplier may be liable to pay compensation for the losses they caused. Visit our website or call us toll free 800-295-3959 to be connected with medical malpractice lawyers who may be able to assist you with your claim.
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