WASHINGTON – U.S. Senators Ben Cardin (D-Md.) and Tina Smith (D-Minn.) are urging Congress to take action to protect patients from prescription drug shortages that could put health outcomes at risk. Legislation they introduced Wednesday, the Drug Shortages Prevention and Quality Improvement Act (S. 2595), would address some of the root causes of drug shortages and extend additional tools the Food and Drug Administration (FDA) can use to mitigate drug shortages.

“It’s unconscionable that basic, and sometimes decades-old medications for heart health and diabetes can be made scarce because manufacturers are unable or unwilling to upgrade outdated technology. We have incredible medicines available that can save lives – but only if they can reach patients in a regular and timely way,” said Senator Cardin. “Natural disasters and other emergencies can play a role in drug shortages, but the federal government must work in the interest of public health to encourage the use of advanced and reliable manufacturing processes of these life-sustaining drugs.”  

“Drug shortages are terrifying, life-threatening public health crises,” said Senator Smith. “Our bill will address some of their root causes to prevent them and help pharmacists and physicians access the drugs they need to treat people. As a member of the Senate Health Committee I’ll continue working to improve drug accessibility and affordability.”

A recent 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.This class of drugs include basic compounds like glucose, potassium, and saline; common medical products like eye drops, insulin, antibiotics, analgesics, epinephrine, and heart medications; and more complex medications used in the treatment of cancer, blood disorders, and hormonal disorders; and vaccines, such as those to prevent COVID-19.

The Drug Shortages Prevention and Quality Improvement Act would address some of these causes of drug shortages and to extend additional tools to FDA to further mitigate problems. This bill would:

• Create a Sterile Injectable Drug Quality Management Maturity (QMM) Pilot Program – The FDA has two ongoing pilot programs to address prescription drug quality related to active pharmaceutical ingredients (API) and finished dosage forms (FDF).[4] This bill would create a QMM program, specifically for sterile injectable drug manufacturers. FDA will create a voluntary pilot program to assess qualifying manufacturer’s quality management maturity system.

• Create 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.[5] The bill would provide grants for sterile injectable drug manufacturers to upgrade facilities to continuous or advanced manufacturing. Grantees would be required to participate in the newly created Sterile Injectable Drug Quality Management Maturity (QMM) Pilot Program.

• 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.

• Extend Shelf Life Dates for Essential Drugs – Shortages of essential drugs may be worsened because short expiration dates require the discarding of drugs that exceed a labeled shelf life. This legislation would require manufacturers of certain essential drugs to update their product’s shelf life to the longest supported expiration date.

The Drug Shortages Prevention and Quality Improvement Act has been endorsed by the American College of Emergency Physicians, American Pharmacists Association, Association for Clinical Oncology (ASCO), American Society of Health-System Pharmacists, On Demand Pharmaceuticals, and US Pharmacopeia.

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