Drug Shortage Legislation Passes the House

10 Jul

Last year, The American Society of Anesthesiologists strongly urged a federal investigation into the drug shortage problem in the U.S. healthcare system. That led to The House Energy and Commerce Health Subcommittee holding a hearing in the fall they called “Examining the Increase in Drug Shortages.” Since then, there has been considerable legislative headway.

Last month, The U.S. House of Representatives overwhelmingly passed the final version of legislation that includes important provisions that address drug shortages.
S.3187, also known as the “Food and Drug Administration (FDA) Safety and Innovation Act,” was written to reauthorize the operations of the FDA’s prescription drug user fee program, which allows the FDA to collect fees from drug manufacturers to support the agency’s operations. Lawmakers, with the urging of the ASA and other advocates, also used the legislation to address drug shortages by including a section with provisions to prevent and mitigate the shortages.
Title X of the legislation requires drug manufacturers to notify the FDA when certain drugs are expected to stop being produced. This includes drugs used in the “treatment of a debilitating disease or condition” and pain drugs used in surgery (anesthesia).
The Food and Drug Administration (FDA) Safety and Innovation Act also include provisions to:
– Direct the Secretary of Health and Human Services to establish a task force to improve the response to drug shortages and create a plan to address aspects of shortages.
– Require the FDA to maintain a drug shortage list and provide it to patients, providers and the public.  
– Authorize the Government Accountability Office (GAO) to conduct a study to examine the reasons for drug shortages and give recommendations on how to prevent or alleviate the shortage. This includes data on how the regulatory framework, manufacturing challenges, or other factors contribute to drug shortages, and recommendations to address issues.
Now it’s just up to the Senate to pass the legislation and the President to sign it.