On Thursday, May 24, 2012, on a bipartisan basis by a vote of 96-1, the U.S. Senate passed S. 3187, the Food and Drug Administration Safety and Innovation Act, 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 seeking to prevent and mitigate national drug shortages.
Originally established at the request of the pharmaceutical industry, PDUFA includes a series of user fees that drug and medical device makers pay to fund the enhanced operations of the Food and Drug Administration (FDA). The law must be re-authorized or legally extended every five years and is currently in its fifth iteration. Important to ASA and as a result of ASA and other stakeholders' lobbying, the PDUFA legislation includes Title X, a portion of the re-authorization legislation dedicated solely to addressing the national shortages of anesthetic and other drugs.
Title X of the PDUFA re-authorization 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. ASA successfully lobbied the Senate Health, Education, Labor and Pensions (HELP) Committee to ensure that the drugs covered under the notification language of Title X included sterile injectable products and drugs used in emergency medical care or during surgery. Additional drugs covered are life-supporting, life-sustaining, and intended for use in the prevention of a debilitating disease or condition. ASA believes this language would cover all drugs used in anesthesia and pain medicine.
Other provisions in Title X of the PDUFA re-authorization would authorize the Secretary of the Department of Health and Human Services (HHS) to process expedited inspections, re-inspections and reviews of drug applications and manufacturing facilities if such actions could help alleviate or mitigate pending drug shortages. Similarly, the legislation would require the Secretary of HHS to consult with appropriate FDA staff to ensure that regulatory enforcement actions don't lead to a meaningful disruption of the supply chain thereby exacerbating or creating a drug shortage.
ASA President Jerry A. Cohen, M.D. offered laudatory remarks saying:
"We applaud the Senate’s passage of PDUFA re-authorization. This legislation marks an important step in ongoing efforts toward addressing drug shortages.
As anesthesiologists continue to confront these shortage,, ASA is proud to continue to be a leader in advocating for solutions and working with legislative and regulatory leaders to combat this drug shortages crisis."
Earlier this month during the 2012 ASA Legislative Conference May 2 "Lobbying Day," more than 500 anesthesiologists visited Capitol Hill urging support for drug shortage relief and highlighting the significant impact drug shortages have on the practice of anesthesia. They noted that anesthetic and central nervous system drugs are experiencing the highest frequency in shortage according to the landmark 2011 Government Account Office report. The Conference attendees also shared with Congressional offices the results of ASA' recent informal survey of 3,033 anesthesiologists experiencing drug shortages that found 97.6 percent had experienced a shortage, 96.3 percent had to use alternative drugs, 50.2 percent had to change the procedure in some way, 7.0 percent had to postpone cases and 4.1 percent had to cancel cases. Most troubling, those who responded to the informal survey reported that six patients (0.2 percent) had died as a result of a drug shortage.
As early as 2009, ASA launched efforts to combat drug shortages when propofol went into shortage. Working hand-in-hand with the ASA, the FDA was able to secure direct importation of Fresenius Proproven to mitigate the propofol shortage. Subsequently, having identified drug shortages as a significant issue for ASA members and their patients, ASA co-convened a drug shortage summit of key industry stakeholders that produced legislative and regulatory recommendations that were promulgated to the FDA and Congress. ASA has executed a concerted effort to draw Congress' and the Administration's attention to this vexing crisis.