How The FDA Could Mitigate Drug Shortages

How The FDA Could Mitigate Drug Shortages

December 19th, 2011 // 4:24 pm @

The ongoing crisis of prescription drug shortages – notably, generic injectables that are used to treat various cancers – remains a vexing problem. But to gain insight into what the FDA could do to address the issue, the US Government Accountability Office reports that a couple of key steps should be taken in order to improve public health.

Notably, the FDA is prevented from requiring drugmakers to provide info about shortages or take certain actions to prevent or alleviate them. As the GAO notes in a newly released report, the only authority the FDA has pertains to reporting discontinued drugs that are life supporting, life sustaining or used to prevent a debilitating disease or condition – when such a drug is made by just one company. Drugmakers are required to provide at least six months of discontinuation, but the GAO found that this has not been the cause of most shortages.

gao-drug-shortages-report1Consequently, the GAO believes the FDA is “predominately reactive.” In fact, less than half of all shortages are reported to the agency by drugmakers. Most of the time, the FDA receives data from the American Society of Health-System Pharmacists, health care providers or consumers. And as the GAO notes, “without such data, the FDA is unable to systematically monitor trends.”

In response, the Generic Pharmaceutical Association issued a statement saying a warning system would be created and participants would include not only drugmakers, but also wholesalers and group purchasing organizations. IMS Health suggested such a system earlier this year (see this). As part of its plan, the trade group wants FDA involvement in the form of a dedicated SWAT team (read here).

At the same time, the GAO found the FDA has demonstrated that it can prevent most shortages when learning of potential supply disruptions in advance. For instance, the FDA has notified other drugmakers to expect increased demand or encouraged them to increase production. In all, the agency prevented 50 potential shortages during the first half of 2011, which is about 1.5 times the number of potential drug shortages prevented during all of 2010.

There is another issue, though, and that is the FDA “has not identified drug shortages as an area of strategic importance.” Its Drug Shortage Program has been consistently staffed with a small number of employees and the FDA has not developed “a set of results-oriented performance metrics” for gauging shortages or identified the topic as an area of strategic importance, the GAO writes (here is the report).

“The agency has not elevated the priority it places on its response to drug shortages, despite the rapid escalation of these shortages,” Marcia Crosse, director of the GAO healthcare office, told the US Senate Committee on Health, Education, Labor, and Pensions. “Although FDA recognizes the serious threat these shortages pose, we believe the agency can and must do more to protect the public health” (here is her testimony).

Meanwhile, here are a few statistics: the number of drug shortages has grown substantially. From January 1, 2001, through June 20, 2011, there 1,190 shortages were reported. From 2006 through 2010, the number of drug shortages increased each year and grew by more than 200 percent over this period. A record number of shortages -196 in all – were reported in 2010 and that is expected to be surpassed this year. And 64 percent of the shortages represent 283 drugs that were in short supply more than once. On average, shortages lasted more than nine months.

fda-drug-shortage-chartThe drug shortages the GAO reviewed in detail were generally caused by manufacturing problems and exacerbated by multiple difficulties – specifically, 12 of 15 shortages reviewed. Although not mentioned in the GAO report, a notable example has been the Ben Venue Laboratories unit run by Boehringer Ingelheim, which recently discontinued production after a series of problems – including finding a jug of urine in a storage area (read here) – and repeated violations found by the FDA and the European Medicines Agency.

However, a recent Senate Finance Committee hearing focused on another theory exacerbating the shortage controversy, such as the way Medicare reimburses health care providers for drugs. “I believe that the drug shortage problem is a direct consequence of the reimbursement system that was set up by the MMA” of 2003, Patrick Cobb, an oncologist at the Frontier Cancer Center and Blood Institute in Billings, Montana, testified, according to ASHP (read here).

He explained the Medicare Modernization Act link to Medicare reimbursement for physician-administered drugs to the average sales price means that physicians lose money on some meds they purchase for patients. In turn, some patients are shifted from physician offices to hospital-based clinics, and drugmakers have responded to price pressures by discontinuing less-profitable meds that cause shortages. However, the Kasey Thompson of the ASHP told there was no evidence to support this.

Nonetheless, economic factors were cited in a recent perspective piece in The New England Journal of Medicine. “If manufacturers don’t make enough profit, they won’t make generic drugs,” wrote Mandy Gatesman of the Virginia Commonwealth University Health System and Thomas Smith of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. “Contamination and shortages of raw materials probably account for less than 10 percent of the shortages. In addition, if a brand-name drug with a higher profit margin is available, a manufacturer may stop producing its generic.” (And here is yet another NEJM perspective piece making a similar point).

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