[Congressional Record Volume 168, Number 8 (Wednesday, January 12, 2022)]
[Senate]
[Pages S191-S192]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. CARDIN (for himself and Ms. Collins):
  S. 3493. A bill to require guidance on extending expiration dates for 
certain drugs, and for other purposes; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. CARDIN. Mr. President, I rise today to highlight legislation I am 
introducing with the senior Senator from Maine, Ms. Collins, to address 
prescription drug shortages. We rely on prescription drugs to battle 
infectious diseases like SARS-CoV-2, for the treatment of cancer and 
hormonal disorders and in countless other facets of modern medicine. 
When drug shortages, which are unforeseen supply disruptions, occur, 
healthcare teams must scramble to develop new plans of care because the 
optimal treatment is no longer available. The Drug Shortages Shelf Life 
Extension Act will help tackle drug shortages by enabling the Food and 
Drug Administration, FDA, to extend the shelf of certain drugs at risk 
of shortage in a safe fashion.
  Prescription drug shortages are a persistent problem, leading to 
diminished access to vital medications and potentially catastrophic 
outcomes for patients. FDA wrote in its 2019 Drug Shortages Task Force 
Report that discarding drugs if they exceed an unnecessarily short 
expiration date can exacerbate drug shortages. Essentially, the shelf 
life for certain drugs can be safely extended, and I support empowering 
authorities to do so to prevent drug shortages.
  Last year, I introduced the Drug Shortages Prevention & Quality 
Improvement Act. The legislation would address some of the main causes 
of drug shortages and provide solutions to mitigate their effects. The 
legislation would give the FDA additional tools to mitigate drug 
shortages, such as extending shelf lives for certain essential drugs. 
This legislation also seeks to address prescription drug shortages by 
creating incentives for manufacturers to upgrade their facilities to 
prevent shortages. 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. The FDA Drug Shortages 
Task Force report found that quality concerns caused 62 percent of drug 
shortages from 2013 to 2017.
  Last April, Senate Health, Education, Labor and Pensions, HELP, 
Committee Chair Murray and Ranking Member Burr announced plans to 
develop a bipartisan initiative to prepare the Nation for future public 
health emergencies in light of the COVID-19 pandemic. I applaud this 
effort to modernize our national response efforts for the current 
pandemic and future pandemics and look forward to consideration of this 
legislation on the floor of the Senate. I was particularly pleased to 
see language included in the HELP Committee's discussion draft for this 
preparedness initiative from the Drug Shortages Shelf Life Extension 
Act. Extending shelf lives of certain

[[Page S192]]

drugs is not only critical to prevent drug shortages but also to enable 
our prescription drug supply chain to be more responsive and better 
prepared to respond to public health emergencies.
  Domestically, we continue to battle the COVID-19 pandemic. We are 
nearing record-high hospitalizations due to COVID-19, including record-
high levels for children. In my State of Maryland, we have encountered 
a new record-high hospitalization level every day since December 29. 
For many patients, the severity and mortality rates are lower due to 
higher vaccination levels and better treatments gleaned from our 
experience in battling COVID-19 so far, but these high hospitalization 
rates are straining an already overburdened system.
  As we continue fighting the pandemic, in addition to other diseases 
and illnesses, timely access to medications is essential for our 
healthcare providers and their patients. The Drug Shortages Shelf Life 
Extension Act would require FDA to update guidance tied to manufacturer 
testing of the shelf life of prescription drug and to report to 
Congress on actions taken to update the shelf life dates of relevant 
drugs. Shelf life expiration dates are established through regulations 
governing prescription drug stability testing, which need to be 
reexamined since they have not been amended since 1981. I look forward 
to working with the Biden administration as it implements this 
essential legislation and related regulations.
  I urge my colleagues to join Senator Collins and me in support of the 
Drug Shortages Shelf Life Extension Act to improve access to essential 
prescription drugs and to prevent or mitigate future drug shortages. No 
one should have to go without essential prescriptions drugs when usable 
supplies are available but have potentially inaccurate use-by dates 
stamped on their box or bottle.

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