Increased FDA authority can help mitigate drug shortages

February 15, 2011

FDA currently lists 178 drugs in short supply, up 33% from 157 in 2009. The most frequent problem of shortage relates to manufacturing or regulatory noncompliance.

Drug shortages are a serious and growing problem. FDA currently lists 178 drugs in short supply, up 33% from 157 in 2009. According to FDA, the most frequent problem of shortage relates to manufacturing or regulatory noncompliance.

Bona Benjamin, director of the American Society of Health-System Pharmacists (ASHP), described the ongoing shortage of the generic oncology product cisplatin. She said there is an increased demand for generic oncology drugs, which firms are unable to meet. On the FDA shortage list, the agency reported, are cisplatin-injection shortages from the 3 generic manufacturers Teva, Bedford, and APP. Teva and Bedford cited manufacturing delays and APP cited increased demand as cause of the cisplatin shortage.

Drug scarcity may also arise from a business decision by manufacturers to terminate a product. But unless a manufacturer is a sole-source supplier and meets FDA’s definition of “medically necessary,” there is no requirement for companies to inform the agency that they are discontinuing a drug. Furthermore, manufacturers have no obligation to report situations such as a shortage of raw materials, packaging, manufacturing, or other problems that could lead to a shortage of a drug. In 2010, 38 potential shortages were averted only because “firms proactively reported pending or actual shortages to the [FDA],” said Benjamin. “We have learned that FDA’s regulatory authority for preventing or mitigating drug shortages is surprisingly limited.”

Dependence upon high-quality, unadulterated, and safe raw materials, as well as proper manufacturing processes - both domestically and globally - also affects drug supply. To protect public interest, FDA inspects U.S. and international facilities to ensure quality and safety and issues a warning letter to companies for manufacturing unapproved drugs or violating current good manufacturing practices. However, these routine but unannounced inspections of manufacturers occur far more frequently in the United States than at overseas sites. Today’s highly complex supply chain and a majority of active pharmaceutical ingredients originating outside the United States have recently prompted action toward new oversight. On December 17, 2010, the Drug Safety Enhancement Act of 2011 (H.R. 6543) was introduced to amend FDA’s surveillance authority and regulation of the global drug market.

“We think expanding FDA authority is an important first step toward resolving the overall shortage problem,” Benjamin said.

At the end of the shortage chain is the effect on health services. Higher co-pays and patient out-of-pocket costs are a reality at the pharmacy counter when pricier alternatives must substitute for an unavailable, first-line drug. Benjamin said payers “will soon be hearing a lot more about drug shortages, if they haven’t already,” adding that ASHP is “focusing on solutions for shortages that should be identified and implemented.”