New bipartisan legislation to address US drug shortages

US Representatives John Carney (Democrat, Delaware) and Larry Bucshon (Republican, Indian) last week introduced the Drug Shortage Prevention Act, HR 3839, to address the scarcity of certain pharmaceutical drugs in the USA’s marketplace.

In 2005, there were 61 different drug shortages. In 2010, that number was 178. Last year, there were more than 230 different drug shortages. Cancer drugs, anesthesia drugs, and nutrition medicines are overwhelmingly affected by these shortages. Those drugs are delivered intravenously, as opposed to in a pill form, and the manufacturing process is complex, time-consuming, and highly precise, the Congressmen note. Many of these drugs have only one or two manufacturers in the market, so when a manufacturing problem occurs, it can quickly cause a shortage.

The legislation mandates expedited review of drugs vulnerable to shortage in order to prevent shortages in the first place and it requires Food and Drug Administration to a use more refined regulatory process that addresses manufacturing problems without instigating drug shortages. The bill also streamlines communications between the FDA, manufacturers, distributors, providers and patients to ensure that all parties have the information they need to act proactively - instead of reactively - to prevent shortages from occurring.