The number of drug shortages has escalated to a record of over 250 this year. The Associated Press reported this past December that at least 15 patient deaths were attributable to drug shortages since mid-2010.
By current law, FDA cannot force manufacturers to report supply disruptions unless they are the only maker of a life-saving drug. On December 7, 2011 and December 15, 2011 the Senate had hearings to address this drug shortage problem. Legislation has already been introduced in both the House and the Senate to mandate that drug manufacturers be required to report to FDA any discontinuous, disruption, or other change that may cause a drug shortage, not just when they are the only drug maker of a life-saving drug. Newly proposed legislation will also allow drugmakers guilty of price gouging or forcing hospitals to buy life-saving drugs that are in shortage at higher prices, to be penalized by up to $500 million dollars for each case.
The Government Accountability Office ("GAO") determined that drug shortages are mostly caused by manufacturing problems. The GAO's solution to this problem would be to give the FDA more information and more authority. When the FDA knows of a shortage, it has the discretion to prevent and alleviate the shortage with steps such as allowing foreign-approved drugs into the U.S. The FDA successfully alleviated 137 shortages over the past two years with advance notification of a potential shortage.
Most of the drug shortages are generic drugs. In response, generic drugmakers plan to set up a private-sector system to inform patients and others of supply problems. The drugmakers will work with distributors, wholesalers, and others to create an advance warning system for the medicines in short supply.