Monmouth Times

Democrats Have Introduced Bills to Strengthen Drug Supply Chain Safety, But Republican Majority Refuses to Act as Crisis Continues

New Brunswick, NJ – With the United States in the middle of one of the worst drug shortage crises in recent memory, Congressman Frank Pallone, Jr. (NJ-06) joined local health officials and providers on July 6 to stress the need for Congress to pass legislation addressing the national drug shortage crisis. 

“Every day there are heartbreaking stories of cancer patients who have had their chemotherapy appointments canceled due to shortages, parents who can’t find children’s aspirin on store shelves, and millions of Americans struggling to fill prescriptions to treat attention-deficit/hyperactivity disorder (ADHD),” Pallone said.  “Democrats have put forward commonsense proposals that would improve our ability to quickly identify and respond to future pharmaceutical and medical device shortages. Unfortunately, the Republican majority has so far refused to act, which is putting American lives at risk. This is a crisis that demands urgent government action, and it is time for Republicans to join us in passing these bills.”

Drug shortages are at a five-year high with the number of drugs in short supply increasing by 30 percent last year alone.  Two chemotherapy drugs used to treat a wide variety of cancers are in short supply, causing the worst chemotherapy shortage in decades. Earlier this year, a confluence of increased cases of influenza, RSV, and COVID-19 led to national shortages of children’s medications. Millions of Americans are struggling to fill prescriptions for ADHD medications following what appears to be increasing demand for the medications.  Pfizer also recently reported an antibiotic shortage that is expected to last well into 2024, part of a nationwide shortage of antibiotics used to treat infections like syphilis, strep throat, and ear infections. 

House Democrats have put forward five bills to help ensure that our nation is prepared for future public health emergencies while providing tools to mitigate ongoing shortages now. The legislation would bring transparency to the drug supply chain by requiring drug manufacturers to report their active pharmaceutical ingredient (API) suppliers to the Food and Drug Administration (FDA). This would help FDA, doctors, and public health officials know which drugs will be impacted by manufacturer delays and move quickly to work with other manufacturers to mitigate shortages.

Another bill would improve mandatory reporting of drug and medical device shortages to help the FDA respond to increased demand and potential shortages when products experience a sudden increase in demand. Other bills provide new tools to support extended shelf life during shortages like the ongoing cancer drug supply shortages and give the FDA recall authority to ensure dangerous products can be removed from the market quickly. 

Pallone, who serves as the top Democrat on the Energy and Commerce Committee, has called on the Committee’s Republican leadership to address the drug shortage crisis as the Committee prepares to reauthorize the Pandemic and All-Hazards Prevention Act (PAHPA). Pallone said drug shortages is a clear and present emergency that demands action and PAHPA, which needs to be reauthorized by September 30, is the natural place to do it. Unfortunately, the Committee Republicans have so far declined to take up the bills as the Committee begins the process of reauthorizing PAHPA.

“At Saint Peter’s, our mission is to serve everyone, especially the most vulnerable in the communities we serve, and to help our patients get the medications they need. Supply chain issues remains a significant challenge nationally, therefore, hospitals need to take shipment delays into account when assessing inventory,” said Leslie D. Hirsch, FACHE, president and CEO of Saint Peter’s Healthcare System. “Saint Peter’s also participates in the federal 340B drug discount program to increase access for our underserved population. Through this program, we have identified drug replacements and purchased drugs at a cost to reduce the financial burden to our organization and the patient. However, it’s important to recognize that the program is not immune to the drug shortages affecting our pharmaceutical supply chains. It’s a complex issue that underscores the need for a broader collaborative effort to find solutions to lessen the potential impact drug shortages on our patients’ health and overall well-being.”

“As an oncologist, I aim to be honest and transparent with my patients about their diagnosis and treatment options. Initially, the shortages seemed to be far away and were not directly impacting patient care in the clinic. At the time, there was little media coverage, and many patients were unaware of what was going on. All that quickly changed as I soon found myself sitting across the room from patients and their families, telling them I could not guarantee they would receive their next chemotherapy on time if at all,” said Dr. Eleonora Teplinsky. “It’s clear the chemotherapy drug shortage won’t be the only one we face. There is a desperate need for incentives to increase generic drug production and to create contingency plans to preempt potential future shortages. These changes will not happen overnight and require continued advocacy and action.”

“The scarcity of many generic drugs, from children’s acetaminophen to antibiotics for strep to many common forms of chemotherapy drugs, have only heightened hospitals’ concerns about patient outcomes and our resolve to forestall a deepening public health emergency,” said New Jersey Hospital Association (NJHA) President and CEO Cathy Bennett. “Ongoing drug shortages also add to the strain on our health care workforce and add costs to our health care system. NJHA applauds Congressman Pallone for leading the effort to shore up medication supplies and ensure patients have access to the right treatments when they need it.”

“Everything changed a year ago when the Adderall shortage began, and I couldn’t access the medication I need. Last month, I called 8 different pharmacies before finding one that had Adderall. Unfortunately, they only had the brand name which my insurance won’t cover and were confident they wouldn’t be getting the generic anytime soon,” saidLisa Wetzel-Trainor, Patient Advocate, Patients for Affordable Drugs. “I decided to pay the full amount for the brand name just so I can take it when I desperately need it. It cost around $250 for 30 pills (when the generic would have cost me $5 with my insurance), and I’m still rationing it because the shortage means that I might not be able to access anything for a long time. But I’m not alone. Right now, patients across the country are facing severe shortages with no end in sight. I’m glad to join Congressman Pallone on July 6 to talk about this important issue and to hear that our government has the power to help solve this crisis.”

Original source can be found here