WASHINGTON – U.S. Senators Ben Cardin (D-Md.), Chair of the Senate Finance Health Care Subcommittee, Tina Smith (D-Minn.), and Richard Blumenthal (D-Conn.) announced they have introduced legislation that will empower the U.S. Food and Drug Administration (FDA) and provide tools to the Centers for Medicare and Medicaid Services (CMS) to address prescription drug shortages that endanger patient health. Their bill, the Drug Shortages Prevention and Quality Improvement Act (S. 2586), would address some of the root causes of drug shortages and extend additional tools the FDA and CMS can use to mitigate this growing problem. The new legislation builds on measures Senator Cardin authored in the Fiscal Year 2023 Omnibus Appropriations Act, including requiring manufacturers of certain essential drugs to update their product’s shelf life to the longest supported expiration date.
“We have incredible medicines available that can save lives – but only if they can reach patients in a timely way,” said Senator Cardin. “Last Congress, we made historic progress addressing health care costs through the passage of the Inflation Reduction Act. However, for patients to benefit from these lower prices, manufacturers and the federal government must work in tandem to ensure life-saving medications remain consistently available for those who need them.”
“Drug shortages can be life-threatening public health crises,” said Senator Smith. “Our bill will address some of their root causes and help prevent them. As a member of the Senate Health Committee, I’ll continue working to improve drug accessibility and affordability so that everyone has access to the medications they need.”
“Our measure takes common sense steps – like extending expiration dates and requiring producers to notify the FDA about increases in demand – that will allow us to prioritize and respond to Americans’ medical needs,” said Senator Blumenthal. “Prescription drug shortages are an unacceptable threat to patients’ health and wellbeing. An outdated manufacturing and quality control process cannot stand in the way of access to life-saving medication.”
The Drug Shortages Prevention and Quality Improvement Act has been endorsed by the American College of Emergency Physicians, the Association of Food and Drug Officials, and the American Pharmacists Association.
“Drug shortages jeopardize the health and well-being of patients in need of lifesaving emergency care,” said Christopher S. Kang, MD, FACEP, President of the American College of Emergency Physicians (ACEP). “Shortages of essential medications used every day in lifesaving procedures are increasingly putting patients at avoidable risk and causing dangerous treatment delays. ACEP deeply appreciates Sen. Cardin’s leadership to mitigate persistent drug shortages and ensure stable access to essential emergency medications.”
“On a daily basis, pharmacists deal with shortages of essential and life-saving drugs, while patients may go without optimal care. In some cases, pharmacists’ hands are tied to recommend and provide ideal treatments because there are no alternatives. Enough is enough,” said Ilisa BG Bernstein, PharmD, JD, FAPhA, Senior Vice President, Pharmacy Practice & Government Affairs of the American Pharmacists Association. “The Drug Shortages Prevention and Quality Improvement Act would provide additional tools, information, transparency, resources, and innovation to prevent drug shortages and build the infrastructure necessary to ensure a reliable and sustainable drug supply so patients can get treatments they need to get better.”
An FDA Drug Shortages Task Force report found that 62 percent of drug shortages from 2013-2017 were caused by quality concerns. Some of the facilities FDA has tied to drug shortages have been operating continually since the 1960s with minimal upgrades to manufacturing lines and facilities. FDA also found that 63 drug shortages from 2013-2017 were among a class called sterile injectable drugs.
A report conducted by the United States Senate Committee on Homeland Security & Governmental Affairs proclaimed that drug shortages increased by roughly 30 percent in 2022, compared to 2021, with the average duration of a shortage at 18 months — though some spanned 15 years. Given that 80 percent of active pharmaceutical ingredients for drugs are manufactured outside of the United States, it is challenging to keep track of the many producers.
- Extend Shelf-Life Dates for Essential Drugs – This legislation would require manufacturers of certain essential drugs to update their product’s shelf life to the longest supported expiration date and allow FDA to issue civil monetary penalties to manufacturers who fail to comply.
- Require Reporting on Increases in Demand for a Drug – Currently, FDA generally does not receive notice from drug manufacturers regarding increases in demand. The legislation would require manufacturers to notify the FDA no later than 30 days after the manufacturer has knowledge of an increase in demand for a drug that is likely to lead to a shortage.
- Provide FDA with Relevant Punitive Penalties – If a manufacturer fails to appropriately report a permanent discontinuance in or interruption of the manufacture of a drug, FDA’s only current recourse is to send a letter to the manufacturer. This legislation would grant FDA the ability to assess civil monetary penalties for manufacturers failing to provide timely and informative notifications around drug shortages.
- Establish Grants for Advanced Manufacturing Upgrades – Manufacturers, particularly of generic sterile injectable drugs, may not have the resources or lack incentives to spend potentially $100 million or more on modernizing their facilities. The bill would provide grants for sterile injectable drug manufacturers to upgrade facilities to continuous or advanced manufacturing.
- Allow for Alternative Payment Under the Medicare Program – This legislation would give the Secretary authority to use the wholesale acquisition cost rather than the producer’s average sales price. CMS, under the inpatient prospective payment system (IPPS), also may implement a modifier for the purpose of tracking the utilization of drugs on the shortage list. Further, the bill would require GAO to conduct a study on drug shortages and the impact alternative Medicare payment systems may have on shortages, which would provide legislative and administrative recommendations to Congress.