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December 21, 2011

FDA Lacks Authority to Prevent Rising Number of Drug Shortages, Report Says

Pharmaceutical companies should be required to notify the U.S. Food and Drug Administration (FDA) of situations that may lead to drug shortages, thereby allowing the agency to address production issues and enhance product availability, according to a new report by the U.S. Government Accountability Office (GAO). 

Though an increasing drug shortage problem in the United States primarily involves injectable generic medications and rarely involves brand-name oral antiretrovirals, some of the treatments now unavailable because of production issues are needed by people living with HIV-associated health complications. 

According to its December 15 report, GAO says the number of drug shortages has grown substantially in recent years, a problem made worse by the fact that the FDA is constrained in its ability to protect the public health from the effects of these shortages. 

Nearly 1,2000 shortages were reported from January 2001, through June 2011, the report notes, many of which were injectable generic drugs for cancer and infectious diseases for which no suitable alternatives are available.  A record number of shortages—196 in total—were reported in 2010, the report authors point out, “and 2011 is on pace to surpass 2010’s record, with 146 shortages reported through June 20, 2011.”  

The drug shortages reviewed by GAO were generally caused by manufacturing problems and exacerbated by multiple difficulties. Twelve of the 15 drug shortages analyzed in detail were primarily caused by manufacturing problems, including those that resulted in manufacturing shutdowns, according to information provided by FDA and manufacturers.

One drug shortage example that has affected people living with HIV involves Doxil (doxorubicin), a chemotherapy used to treat Kaposi’s sarcoma (KS), produced by Ben Venue Laboratories, a subsidiary of Boehringer Ingelheim Pharmaceuticals. On November 19, the company announced that it was temporarily shutting down its Bedford, Ohio–based production plant after metal particles were detected in some of its drugs. More than a month later, plans to reopen the facility have not been announced and Doxil remains largely unavailable.

Though it is unclear if the FDA would have been able to prevent the shortage of Doxil—Ben Venue notes it is working with the agency to remedy the problem—the agency’s response to drug shortages is often limited by its lack of authority to require manufacturers to report potential or current shortages to agency officials. 

According to the GAO report, which analyzed FDA’s authority under the Food, Drug and Cosmetic Act and a review of relevant FDA regulations, policies, procedures and documents, the agency can prevent the majority of such shortages from occurring. However, it does not currently have the authority to require manufacturers to provide it with information about potential or current shortages, and therefore it can only prevent the shortages that it becomes aware of through voluntary reporting. 

FDA’s ability to protect the public health is also constrained by its own management challenges, the report suggests. The agency has not elevated the priority it places on its response to drug shortages—its Drug Shortage Program consists of only a small staff, for example—despite the rapid escalation of these shortages. “Not only have its resources not kept pace with this escalation,” the report states, “the agency has not developed the metrics to manage this growing public health problem.”

“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 health care office, told the U.S. Senate Committee on Health, Education, Labor and Pensions on December 15. “Although FDA recognizes the serious threat these shortages pose, we believe the agency can and must do more to protect the public health.”

In February 2011, Senator Amy Klobuchar (D–Minn.) and Senator Bob Casey (D–Penn.) introduced S. 296, the Preserving Access to Life Saving Medications Act, with a companion bill, HR 2245, introduced in the House in June by Representative Diana DeGette (D–Colo.) and 61 cosponsors. These pieces of legislation would require manufacturers to notify the FDA when they experience manufacturing problems or when a drug is to be discontinued. The bills would also provide the agency with improved capacity to prevent drug shortages.

Search: drug, shortages, FDA, Food and Drug Administration, Doxil, Klobuchar, Casey, Degette, Preserving Access to Life Saving Medications Act, S. 296, HR 2245

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