San Diego City Wire

In response to the shortage of children’s Tylenol and Motrin that’s left store shelves empty for months across the country, Congresswoman Sara Jacobs (CA-51) and Congressman Cory Mills (FL-07) introduced bipartisan legislation to minimize and prevent future drug shortages. The Drug Shortage Prevention Act would require manufacturers to notify the FDA if they experience six consecutive weeks of an increase in product demand to minimize drug shortages and improve the FDA’s predictive ability and responsiveness.

 “When you have a sick child, all parents want to do is help their child feel better. But for months, drug shortages of children’s Tylenol and Motrin have prevented millions of parents from getting the medication they need to relieve children’s flu, RSV, and COVID symptoms,” said Congresswoman Sara Jacobs. “The Drug Shortage Prevention Act will help lessen parents’ worries by creating more transparency of the demand for medication and minimizing drug shortages.”

 Congressman Cory Mills said: “Many Americans don’t think about critical medicines until they need them and can’t access them. Parents shouldn’t be put in a bind because, through no fault of their own, the drugs they need while caring for their children aren’t available. Especially when there are ways for the government to be a resource to manufacturers to avoid shortages of drugs like Infants’ Tylenol, Congress must provide manufacturers with mechanisms to proactively resolve these supply chain issues. I am pleased to join Congresswoman Sara Jacobs (CA-51) in introducing the Drug Shortage Prevention Act, and I look forward to working with my colleagues in Congress to advance this legislation.”

 “It’s critically important that parents and caregivers have uninterrupted access to the medication their child needs, whether it’s an over-the-counter treatment for cold and flu symptoms, or a prescription drug to manage a chronic condition,” said Nicholas Holmes, MD, Senior Vice President and Chief Operating Officer at Rady Children’s Hospital-San Diego. “With its potential to minimize drug shortages and bring peace of mind to caregivers, Rady Children’s endorses this important measure.”

 The Drug Shortage Prevention Act would: 

• Require manufacturers to provide initial notification to the FDA no more than 48 hours after a sustained increase in demand for a drug, active pharmaceutical ingredient, or excipient for six consecutive weeks, including for over-the-counter medications 
• Require a subsequent notification 30 days after the initial submission with additional information, including the expected duration of the interruption    
• Direct the FDA Commissioner to properly publish and distribute information on the drug shortage to appropriate organizations including physicians, health providers, and patient organizations    
• Through consultation with relevant stakeholders, directs the FDA to issue draft and final guidance to manufacturers outlining information necessary to improve demand predictability 

Original source can be found here.