The U.S. Food and Drug Administration (FDA) is aware of the major public health consequences that can result from drug shortages. These shortages occur for various reasons including manufacturing and quality problems, delays, and discontinuations. When problems are discovered, the FDA works with the drug company to address risks involved to prevent harm to patients and works to restore supplies while ensuring safety for patients, according to the FDA Office of Health and Constituent Affairs.
Shortages of a large number of common pharmaceuticals, many of which are staples of medical care, are concerning medical professionals and potentially endangering patients. In March 2016, there were 195 drugs in short supply in the United States, many of them essential for treating patients in emergency rooms, outpatient clinics and ICUs (intensive care units), reports the University of Utah’s Drug Information Service, which tracks supplies.
Recent Drug Shortages
A recent list of drug shortages voluntarily reported by manufacturers include: Tolmetin Sodium Tablets, USP, Albuterol Sulfate Inhalation Solution (0.5%), Hydroxyamphetamine Hydrobromide/Tropicamide (Paremyd), Delavirdine Mesylate (RESCRIPTOR) Tablets, Galantamine Tablets, Glyburide Metformin Tablets, Glyburide Tablets, Indomethacin Capsules, and Methylphenidate Hydrochloride Tablets, USP.
A detailed list of drug shortages published by the FDA in June of last year was daunting. Most were generic injectable medications, including analgesics, cancer drugs, anesthetics, products needed for cardiovascular and psychiatric emergencies, and electrolytes needed for patients on IV (intravenous) supplementation. In 2015, an acute shortage of a cancer drug called BCG caused many of the thousands of patients dependent on the drug to go without, or to receive inferior alternatives, according to Forbes.
National law firm Parker Waichman LLP has extensive experience and success representing clients in all types of litigation. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.
Alternatives When Necessary
When faced with shortages of medications ranging from painkillers to heart medicines, some paramedics are forced to administer outdated prescriptions. Hospitals do what they can to assure adequate supplies of drugs that are in short supply, or to find alternatives for them, but in many instances, patients are not getting the drugs that healthcare professionals would prefer to give.
The problem has multiple causes, some of which are interrelated. First, shortages may occur when there are problems with quality control or other manufacturing glitches, including production delays at the manufacturer, delays in availability of raw materials and components from suppliers. Also, more than half of the drugs on the FDA’s shortage list are supplied by no more than three manufacturers, and many production lines run 24/7 making more than one drug. In that case, if one facility experiences production or regulatory glitches or cannot obtain ingredients, other companies cannot step up production quickly, reports Forbes.
A second factor is economics. It costs more to manufacture sterile injectable drugs – which are heavily represented among the products experiencing shortages, while their selling price remains relatively low. This is largely because they are off-patent and subject to federal Medicare and Medicaid reimbursement policies that prevent prices from responding to market conditions.
Effect of Generics on Brand-Name Drugs
Third, the withdrawal from the market of brand-name drugs when generic versions become available may reduce the number of producers of a given product. Once generic versions of a drug are marketed, the previously patent-protected brand name version rapidly loses market share, the retail price drops and the innovator company begins to receive markedly reduce revenues from its brand-name product. Often, that causes the innovators, the companies with the most experience manufacturing the product, to stop making the drug and abandon the marketplace to generic manufacturers, according to Forbes.
Slow New Drug Approval
Drug manufacturers complain that the FDA has been unpredictable and slow to approve new facilities and manufacturing processes, exacerbating interruptions in production. On occasion, the FDA has demanded that a new drug demonstrate superiority over existing therapies, which exceeds the statutory requirement that a drug simply be safe and effective.
Bringing a new drug to market now requires on average 10 to 15 years and costs more than $2.5 billion. Perhaps the most ominous statistic of all is that drug manufacturers recoup their costs for only one in five approved drugs. That represents deterioration from one in four about ten years ago. Thus, drug companies pursue fewer products, especially when other similar medicines are already on the market, leaving fewer alternatives in case of a disruption in the supply of one drug, Forbes reports.
It is documented in a report by the House Committee on Oversight and Government Reform, FDA’s “overzealous” inspections and enforcement actions have engendered drug shortages. FDA regulatory activity has effectively shut down 30 percent of the total manufacturing capacity at four of America’s largest producers of generic injectable medications: Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals.
Contaminated or otherwise substandard drugs can clearly endanger patients, but the House report concluded, “Among shuttered manufacturing lines that occurred over the previous two years, the committee’s review did not find any instances where the shutdown was associated with reports of drugs harming customers.”
Legal Information and Advice
If you or someone you know has been affected by drug shortages, you may be eligible for valuable compensation. The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).