May 31, 2012
U.S. House of Representatives Passes PDUFA Reauthorization That Includes Drug Shortages Provisions
On May 30, the U.S. House of Representatives, by a vote of 387-5 passed the Food and Drug Administration Reform Act of 2012, H.R. 5651, commonly referred to as the Prescription Drug User Fee Act (PDUFA) Reauthorization, a legislative package of important Food and Drug Administration (FDA) provisions including one to prevent and mitigate national drug shortages. Last week, the U.S. Senate passed a separate PDUFA reauthorization bill that also addresses the drug shortage issue.
Title IX of the House PDUFA reauthorization includes specific requirements for enhanced manufacturer notification to FDA that would enable the agency to use its existing authority to respond in a timely fashion to a manufacturer's decision to halt or interrupt production of a key drug.
Other provisions in Title IX of the PDUFA reauthorization would authorize the Secretary of the Department of Health and Human Services (HHS) to process expedited inspections and reviews of drug applications and manufacturing facilities if such actions could help alleviate or mitigate pending drug shortages. ASA was pleased to see that that the Committee included language to "require the Drug Enforcement Administration (DEA) to provide timely approvals or denials of increases in quotas of controlled substances in instances where such an increase could help address a drug shortage." Also, the legislation requires a Government Accountability Office (GAO) Study to examine the issue of drug shortages.
With regard to future consideration of the legislation, the House version of PDUFA must now be reconciled with the Senate version of the measure. A number of differences will need to be addressed by lawmakers. The process of reaching agreement on the differences is expected to begin immediately.
Review the House legislation.
Review the Senate legislation.
Review the Summary of House Passed Legislation.
Send the FDA an email reporting a drug shortage.