June 26, 2012
Senate Passes Final FDA Bill Including Key ASA-Advanced Drug Shortage Provisions – President Expected to Sign
On June 26, by a vote of 92-4 , the U.S. Senate passed the final version of legislation, S.3187, the "Food and Drug Administration (FDA) Safety and Innovation Act," which contains important provisions to address drug shortages.
Last week, the House passed the same legislation by a voice vote. The President is expected to sign the Food and Drug Administration Safety and Innovation Act into law in the coming days.
As previously noted, this legislation was written principally to reauthorize the operations of the FDA’s prescription drug user fee program – a program that allows the FDA to collect fees from drug manufacturers to support the agency's operations. However, at the urging of ASA and other drug shortage stakeholders, lawmakers used this bill as the vehicle to address the national drug shortage issue. Specifically, the bill includes an entire title or section consisting of provisions intended to help prevent and mitigate drug shortages.
Title X of S.3187 contains a number of ASA-advanced provisions that will help address shortages of anesthesia drugs. Of particular note, the legislation includes "notification" language that requires manufacturers to notify the FDA when the production of certain drugs would be halted or interrupted. ASA worked to ensure that the definition of the drugs to be reported included drugs used in the "treatment of a debilitating disease or condition," a definition that includes pain drugs and drugs used "during surgery," and a definition that includes anesthesia drugs. This notification requirement will allow the FDA to use its existing authority and resources to work with manufacturers to reverse or mitigate any production changes.
The legislation also includes language to require the Drug Enforcement Administration (DEA) to provide timely updates on decisions regarding controlled substance quota increases to manufacturers when such an increase could help address a drug shortage.
These two key provisions were among the consensus recommendations of the ASA co-convened "Drug Shortage Summit" work group, a group of stakeholders that first met on November 5, 2010.
The Food and Drug Administration Safety and Innovation Act also includes ASA-endorsed provisions that:
- Direct the secretary of Health and Human Services to establish a task force to enhance the Department’s response to shortages, and create a strategic plan to address stated aspects of shortages.
- Require the FDA to maintain a drug shortage list and provide patients, providers and the public with such information in order to prevent, mitigate and manage drug shortages on the ground.
- Authorize the Government Accountability Office (GAO) to conduct a study to examine the causes of drug shortages and issue recommendations on how to prevent or alleviate a drug shortage. This provision would provide needed data on how the regulatory framework, manufacturing challenges or other factors contribute to drug shortages, as well as recommendations to address such issues.