Brown, Colleagues Sent Letter to Biden Administration Urging Action on Amoxicillin Shortage; Brown Also Introduced Bill to Establish a Domestic Stockpile of Active Pharmaceutical Ingredients for Essential Medicines
WASHINGTON, DC – November 30, 2022 – Today, U.S. Sen. Sherrod Brown (D-OH) hosted a news conference call to discuss a bipartisan letter he and several Senate colleagues wrote to the Biden administration to address the current shortage of the antibiotic amoxicillin.
“No child should have to wait –trying to battle a simple infection that turns into something much worse – because they couldn’t get the medicine they need,” said Brown. “It’s past time to take steps to ensure our medical supply chains can accommodate increased demand for a common, potentially lifesaving drug and give families peace of mind.”
Amoxicillin is the front-line antibiotic used to treat many childhood illnesses ranging from ear infections to pneumonia. The FDA reported a shortage of the liquid version of the drug last month due to increased demand, the shortage primarily affects pediatric patients. Dr. Kevin Turner, a pediatrician and medical director of the Rainbow Primary Care Institute at University Hospitals in Cleveland joined the call. He said ongoing drug shortages are affecting health systems in Ohio and across the nation.
“Amoxicillin is the most commonly used antibiotic for children. It’s what we call the first-line therapy for pneumonia and ear infections in most kids,” said Turner. “The ongoing shortage is a challenge, however for right now it is not a reason to panic as we are able to manage the shortage for the safety and care of our patients.”
Pharmacist and director of ambulatory pharmacy services at Dayton Children’s Hospital Chad Meyers also joined the call, talking about the impact the shortage has had on families and providers.
“The shortage of amoxicillin is an ongoing challenge for community pharmacies and families with young children,” says Meyers. “We’ve had families drive almost an hour because the Dayton Children’s pharmacy was the only one that had amoxicillin available for their child. We are grateful we have the capability to go above and beyond in making sure we have viable antibiotic treatment options available for all children within our reach.”
The bipartisan letter to the Secretary of Health and Human Services and to the FDA Commissioner asked both agencies to start a drug shortage task force to address the shortage.
“We write to express our strong concern regarding the shortage of amoxicillin and the serious threat that this and other medical shortages pose to our nation’s patients and public health,” the senators wrote to Health and Human Services Secretary Xavier Becerra and Food and Drug Administration (FDA) Commissioner Robert Califf, MD. “The record high levels of respiratory illnesses have spiked demand for amoxicillin and other essential medicines, and patients and providers continue to experience disruptive shortages, which have led to delays in care and compromised health outcomes.”
Brown also discussed his bipartisan Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act of 2021, which would create a one-year, emergency supply of key ingredients used in essential generic medicines and incentivize domestic manufacturing of these ingredients to build a more resilient domestic supply chain.
The full text of the bipartisan letter sent to the Biden administration can be viewed here and below:
Dear Secretary Becerra and Commissioner Califf:
We write to express our strong concern regarding the shortage of amoxicillin and the serious threat that this and other medical shortages pose to our nation’s patients and public health. Parents, patients, and health providers across the country have shared how this shortage has adversely impacted patient care.
As you know, amoxicillin is used to treat bacterial infections, and the Centers for Disease Control and Prevention recommends its use as a “first line therapy” for multiple pediatric illnesses. The record high levels of respiratory illnesses have spiked demand for amoxicillin and other essential medicines, and patients and providers continue to experience disruptive shortages, which have led to delays in care and compromised health outcomes.
We urge the Department of Health and Human Services and the Food and Drug Administration (FDA) to convene the Drug Shortage Task Force and work with stakeholders, including providers, on identifying factors and potential solutions to mitigating the amoxicillin shortage. Further, we request an update on FDA initiatives to prevent and mitigate drug shortages.
We look forward to working with the Department and its agencies in continuing to address medical shortages as the manufacturing and health care landscape evolve.