WASHINGTON— U.S. Senator Amy Klobuchar joined a bipartisan group of 31 senators in urging Food and Drug Administration (FDA) Commissioner Scott Gottlieb to address the ongoing drug shortage crisis across the United States. In the letter, led by Senators Chris Murphy (D-CT) and Bill Cassidy, M.D. (R-LA), the senators requested that the Drug Shortage Task Force determine the cause of drug shortages and present its recommendations to Congress by the end of 2019.
“[D]rug shortages continue to present consistent, frequent, and significant risks for patients and threaten the stability of our health care system,” the senators wrote. “These persistent shortages can last for months or longer and affect all classes of medications used in a variety of settings – emergency departments, hospitals, ambulatory surgical centers, among others. Shortage medications include local anesthetics, injectable opioids, ophthalmic diagnostics, and even sterile IV fluids necessary for delivering nearly every drug used in an emergency department or surgical setting. These are essential products used every day, and for many of them there are no suitable alternatives that are readily available.”
“We respectfully request that the Drug Shortage Task Force work with stakeholders and federal agencies to determine the root causes of drug shortages and develop recommendations to ensure that appropriate supplies of essential medications are always available. We ask that the task force submit its recommendations to Congress no later than the end of 2019. Thank you for your consideration of this request,” the senators added.
Klobuchar, Murphy, and Cassidy were joined by U.S. Senators Tammy Baldwin (D-WI), Michael Bennet (D-CO), Richard Blumenthal (D-CT), Roy Blunt (R-MO), Ben Cardin (D-MD), Tom Carper (D-DE), Bob Casey (D-PA), Tammy Duckworth (D-IL), Dianne Feinstein (D-CA), Cory Gardner (R-CO), Orrin Hatch (D-UT), Dean Heller (R-NV), Doug Jones (D-AL), Tim Kaine (D-VA), Angus King (I-ME), Patty Murray (D-WA), Bill Nelson (D-FL), Rand Paul (R-KY), Gary Peters (D-MI), Bernie Sanders (I-VT), Brian Schatz (D-HI), Jeanne Shaheen (D-NH), Tina Smith (D-MN), Debbie Stabenow (D-MI), Jon Tester (D-MT), Chris Van Hollen (D-MD), Sheldon Whitehouse (D-RI), Todd Young (R-IN).
Klobuchar has championed efforts to protect consumers and lower prescription drug costs by promoting competition in the healthcare system. In February, Klobuchar sent a letter urging the FDA to examine additional actions the agency can take to alleviate the shortage of IV bags and saline solution during this year’s unusually severe flu season. In 2015, Klobuchar and a bipartisan group of senators urged the Federal Trade Commission to investigate possible illegal collusion by saline manufacturers. The Food and Drug Administration Safety and Innovation Act, signed into law in 2012, includes a bipartisan drug shortages agreement Klobuchar helped forge that require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage. The bill also contained Klobuchar’s provisions directing the FDA to expedite inspections and reviews of manufacturing sites or new products that could be helpful in addressing a drug shortage, and require the FDA to keep detailed records of previous drug shortages and the actions taken to prevent them.
Klobuchar has also authored multiple pieces of legislation that would address the high cost of prescription drugs. Last week, bipartisan legislation she cosponsored to address the rising costs of prescription drugs has passed the Senate Judiciary Committee. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to delay the approval of lower-cost generic drugs. Klobuchar introduced legislation—that has 34 cosponsors—to lift the ban on Medicare negotiating for the best possible price of prescription drugs for nearly 41 million seniors enrolled in Medicare Part D. Last year, Klobuchar and Senator John McCain (R-AZ) introduced the Safe and Affordable Drugs from Canada Act, bipartisan legislation that would allow individuals to safely import prescription drugs from Canada. Klobuchar has also introduced the bipartisan Preserve Access to Affordable Generics Act with Senator Chuck Grassley (R-IA) to limit “pay for delay” deals—the practice of brand-name drug companies using anti-competitive pay-off agreements to keep more affordable generic equivalents off the market. Klobuchar’s Short on Competition Act, introduced with Senator Mike Lee (R-UT), would allow temporary importation of drugs that have been approved in another country with similar safety requirements and face little or no competition in the U.S.
The full text of the letter can be found below:
Dear Commissioner Gottlieb:
We write to request your assistance in addressing our nation’s ongoing and worsening drug shortage crisis, an issue that threatens the health and safety of our constituents and hinders the ability of health care providers to deliver high-quality care. First, we would like to commend your recent statement regarding the FDA’s efforts to mitigate shortages of intravenous drugs, shorten supply disruptions, and better predict vulnerabilities. We believe the actions you laid out and information you presented are positive steps in addressing drug shortages. As part of your efforts to resolve this critical issue, we urge the Food and Drug Administration to convene the Drug Shortage Task Force created by the Food and Drug Administration Safety and Innovation Act (FDASIA), stakeholders, and other relevant agencies to develop a report and recommendations to Congress regarding the root causes of drug shortages and the authorities FDA and other federal agencies need to address these causes and ensure that appropriate supplies of essential medications are always available.
We appreciate the work of the agency to mitigate the impact of shortages created in the wake of Hurricane Maria and recent shortages resulting from manufacturing deficiencies. However, drug shortages continue to present consistent, frequent, and significant risks for patients and threaten the stability of our health care system. These shortages are not a new issue. A 2014 Government Accountability Office (GAO) report noted that shortages have resulted in “delays in or rationing of care, difficulties finding alternative drugs, risk associated with medication errors, higher costs, reduced time for patient care, and hoarding or stockpiling of drugs in shortage. During a shortage, providers may have to cancel or delay procedures, which can have detrimental health effects on patients.”
These persistent shortages can last for months or longer and affect all classes of medications used in a variety of settings – emergency departments, hospitals, ambulatory surgical centers, among others. Shortage medications include local anesthetics, injectable opioids, ophthalmic diagnostics, and even sterile IV fluids necessary for delivering nearly every drug used in an emergency department or surgical setting. These are essential products used every day, and for many of them there are no suitable alternatives that are readily available. This can result in suboptimal pain control or sedation for patients, and ultimately limit patient access to the most appropriate care. In fact, in a recent member survey conducted by the American Society of Anesthesiologists, 98 percent of respondents indicated they regularly experience anesthesia drug shortages, and 95 percent said the shortages adversely affect patient care. A recent member survey by the American College of Emergency Physicians (ACEP) showed similar results, with 91 percent of respondents experiencing shortages or absences of critical medicines.
While important strides have been made since the height of the drug shortage crisis in 2012 and the subsequent enactment of FDASIA, and the number of new shortages reported to the FDA per year has decreased over time, the total number of unresolved shortages continues to be problematic to the health system according to FDA’s own data. The damage inflicted upon certain drug manufacturing facilities by Hurricane Maria in 2017 not only exacerbated these existing shortages, but exposed just how fragile our current system is, highlighting the need to take action to improve redundancy and preparedness in our supply chain.
We recognize there are many different factors that contribute to drug shortages, and we believe that a better understanding of how these factors interact with one another and the degree to which they affect shortages can help shape policy actions. We respectfully request that the Drug Shortage Task Force work with stakeholders and federal agencies to determine the root causes of drug shortages and develop recommendations to ensure that appropriate supplies of essential medications are always available. We ask that the task force submit its recommendations to Congress no later than the end of 2019. Thank you for your consideration of this request.