Representative Elissa Slotkin | Official U.S House Headshot
Representative Elissa Slotkin | Official U.S House Headshot
WASHINGTON, D.C. – U.S. Rep. Elissa Slotkin (MI-07) today unveiled new legislation to expand supply of critical drugs during shortages. The Ensuring Access to Lifesaving Drugs Act would, in the event of a shortage, empower the Food and Drug Administration (FDA) to require drug manufacturers to label drugs with the longest scientifically-supported expiration date, expanding supply of usable drugs.
The bill comes amid shortages of hundreds of critical drugs, including cancer treatment drugs in Michigan so severe that hospitals and health care providers have been compelled to cancel patients’ appointments. In June, Slotkin wrote to the FDA with Sen. Debbie Stabenow (D-MI) and Sen. Gary Peters (D-MI) urging the administration to “do everything in its power to alleviate the strain on patients and prevent delays in life-saving treatments.”
“As someone whose mom died of ovarian cancer, I can’t imagine how families whose loved ones’ treatment has been interrupted due to a drug shortage must feel,” said Slotkin. “This legislation cuts red tape to help the FDA take action and keep lifesaving pharmaceuticals on shelves in the face of a shortage. It’s vital that the availability of critical drugs not fall into question, and when it’s threatened, we need to have tools at the ready to address it head on.”
“The current shortage of lifesaving cancer drugs is compromising care for patients with serious illness and dramatically increasing the cost of the remaining supply of pharmaceuticals like cisplatin. The Michigan Hospital Association and its members applaud the immediate and thoughtful legislative effort by Congresswoman Slotkin to improve the availability of chemotherapy and other important medications,” said Brian Peters, CEO, Michigan Hospital Association.
“Patients with serious illnesses, including cancer, deserve access to the best available lifesaving drugs – even when drug shortages make this a challenge. The Ensuring Access to Lifesaving Drugs Act gives FDA the power to balance the risks and benefits of extending the expiration date of drugs during a shortage, when it is safe to do so -- particularly when the alternative is patients going without. Giving both FDA and industry the tools and motivation to maximize the shelf-life of lifesaving drugs during shortages is an important step in the right direction," said Andrew G. Shuman M.D., Chief, Clinical Ethics Service at the University of Michigan Medical School, Associate Chief of Staff, VA Ann Arbor Healthcare Systems
Slotkin has been a longtime advocate for strengthening supply chains for critical pharmaceuticals. She co-founded the Domestic Pharmaceutical Manufacturing Caucus, a working group in Congress focused on restoring America’s drug manufacturing industry in order to head off potential supply chain disruptions. In December 2022, her Strengthening America’s Strategic National Stockpile Act, which would make improvements to America’s Strategic National Stockpile of medical supplies, was passed by Congress and signed into law.
Original source can be found here.