Rampant drug shortages demand the attention of everyone—from patients to Obama
By Patrick Kenney
Every year, there are periods during which certain drugs are in short supply. Hospitals and pharmacies scramble to make up the difference, and patients are sometimes forced to make sacrifices.
The problem is a constant in healthcare, and the causes are difficult to understand. News reports suggest that it could be the fault of the U.S. Food and Drug Administration (FDA), delaying drugs with regulation. The FDA did not respond to repeated interview requests. Some suggest that the Drug Enforcement Administration (DEA) is responsible for shortages of certain controlled substances by setting volume-manufacturing limits below the level of patient need. In an interview with National Public Radio last month, Gary Boggs of the DEA’s Office of Diversion Control denied the existence of a shortage. But one only needs to see the FDA’s list of current drug shortages, provided voluntarily by manufacturers and last updated as recently as Nov. 23, to see that Boggs is denying the facts. The Chicago office of the DEA was unable to respond to interview requests before press time.
Other reports suggest that manufacturers are cutting the production of less-profitable drugs. The shortages are most prevalent among generic, less-expensive medications. Suppliers have been accused of gouging prices during shortages, which has led Rep. Elijah Cummings, D-Md., to initiate a congressional investigation into the alleged behavior.
One thing’s for sure, the ever-present problem is escalating into a crisis. The Associated Press reported that the number of new drug shortages occurring each year has tripled since 2006. As of November, 251 new drug shortages were reported this year. The majority of the drugs in short supply are potentially life-saving treatments for cancer, infections and cardiovascular disease.
Hearings have been held in Congress, and both the House and Senate have introduced legislation to address the problem. In October, President Barak Obama issued an executive order, which, among other things, instructed the FDA to speed up the process of review in cases where increased manufacturing is needed to stave off shortage.
One of the many drugs in short supply are tablets of dextroamphetamine, more commonly known as Adderall, a drug used to treat Attention Deficit Hyperactivity Disorder. It’s estimated that as many as 15 million Americans suffer from ADHD. Over half of children diagnosed with the disorder take medication for it. Adderall helps a person to maintain mental focus. It has been proven to be habit forming, and manufacturing limits are set by the DEA. The shortage has come at an inopportune time, during finals, for college students with the disorder.
The American Society of Health-System Pharmacists monitors drug shortages and keeps records of up-to-date information. According to its website, the sole manufacturer of dextroamphetamine tablets, Teva Pharmaceuticals, is unable to provide a reason for the shortage. And although Teva admits to having shortages for other medications on the FDA’s shortage list, it does not list dextroamphetamine as one of them.
This confusion is not rare. And although Teva is not alone in its apparent lack of understanding, the fact that it is the only manufacturer of dextroamphetamine tablets, speaks to one of the problems that may be leading to shortages.
Most of the 200+ drugs in short supply are manufactured by only one or two companies. Therefore, a problem with production at one of these companies can lead to widespread shortages.
Unfortunately, efforts underway to understand the drug-shortage problem have yet to yield significant and clear results. But there is one thing that experts seem to agree on; the crisis won’t be resolved anytime soon.