In Wake of Coronavirus Outbreak, Reps. McCaul, Peters, Engel, Guthrie, Eshoo, Hudson, Schrader, Bilirakis Introduce Bipartisan Bill to Prevent Critical Access Drug Shortages
WASHINGTON, D.C. – Today, Rep. Michael McCaul (TX-10), Rep. Scott Peters (CA-52), Rep. Eliot Engel (NY-16), Rep. Brett Guthrie (KY-02), Rep. Anna G. Eshoo (CA-18), Rep. Richard Hudson (NC-08), Rep. Kurt Schrader (OR-05), and Rep. Gus Bilirakis (FL-12) introduced the bipartisan Preventing Drug Shortages Act, which would help address the critical issue of drug shortages that affect the quality of care patients receive across the country. The introduction of the bill comes days after the Food and Drug Administration (FDA) announced the first U.S. drug shortage related to factory shutdowns and shipping problems in China due to the recent Coronavirus Disease 2019 (COVID-19) outbreak.
According to the FDA, in recent years drug shortages have steadily increased, and supply chains may become further stressed by the challenges associated with the new coronavirus outbreak. Most drug shortages stem from a supply chain interruption, often created by natural disasters, over-reliance on foreign pharmaceutical products, or manufacturing and distribution problems. These shortages threaten the adequate delivery of first-rate patient care, as deficiencies of drugs commonly used by hospitals to treat acute conditions, including bacterial infections and cancer treatment, can severely limit Americans’ access to lifesaving medicines.
The Preventing Drug Shortages Act would help mitigate these shortage triggers by enhancing transparency throughout the drug supply chain process and strengthening FDA interagency efforts to fend off drug shortages. The bill would also empower the FDA to enforce greater reporting standards on drug and active pharmaceutical ingredient makers to identify and correct vulnerabilities in their supply chains.
“Our country’s drug supply is heavily reliant on China, as we have seen in a recent drug shortage due to the Coronavirus outbreak. The Preventing Drug Shortages Act is a step in the right direction in addressing prevention, notification, and mitigation strategies not just in regards to China, but our entire drug supply chain,” said Rep. McCaul. “If a manufacturer has a contingency plan in place, and gives the FDA enough notice, the better the FDA can find alternatives to keep supply consistent. A patient should not be at risk because there was a failure of the supply chain.”
“Drug shortages under normal circumstances result in significant strain throughout our healthcare system—from patients to hospitals and physicians,” said Rep. Peters. “Unfortunately, the health emergency presented by COVID-19 is exacerbating these problems and we are already beginning to experience its adverse reactions on global drug supply chains. While we may never be able to predict or fully prevent the challenges posed by situations like the coronavirus outbreak, Congress should take steps to fortify drug supply chains. By strengthening efforts across the board to prevent drug deficiencies, my bill would help ensure America’s health centers have access to the proper resources they need so that patients can continue to receive reliable treatments.”
“As the number of coronavirus cases grows in New York, it’s critical that we take all proactive steps to ensure our health care providers have the medications to treat affected New Yorkers,” said Rep. Engel. “Many of our critical medications are sourced from China and India. The growing outbreaks in these countries and the first reported coronavirus-related drug shortage underscore the need to protect and secure our drug supply chain needs. I am pleased to help author this bipartisan legislation which will help mitigate these issues.”
“Whether it is an outbreak like the coronavirus, a natural disaster, or any number of possible interruptions to our drug supply chain, we need to ensure that Americans have access to lifesaving drugs at any time,” said Rep. Guthrie. “The Preventing Drug Shortages Act will increase transparency in our drug supply chain so we can better identify where our system can be improved. I want to thank Reps. Peters, Engel, Hudson, Eshoo, McCaul, Schrader, and Bilirakis for joining with me in introducing this bipartisan, commonsense legislation.”
“The coronavirus outbreak has demonstrated how susceptible our nation’s drug supply chain is to disruptions that could have devastating impacts on our public health because of our overreliance on China for generic drugs. The Coronavirus has already caused one shortage and it’s unclear if there are more to come,” Rep. Eshoo said. “This legislation takes some first steps to increase what information the federal government needs to receive from drug manufacturers about ongoing shortages and requires manufacturers to have risk management plans to mitigate the impact of drug shortages that affect the American people.”
“Too often I’ve heard from constituents and providers that access to lifesaving drugs has been interrupted because of a drug shortage. We cannot let this continue to happen, especially as new threats like coronavirus emerge,” said Rep. Hudson. “The Preventing Drug Shortages Act will bolster the data we have available to recognize these shortfalls earlier and eliminate potential shortages of lifesaving medications. I appreciate the partnership of Reps. Peters, Guthrie, Engel, Eshoo, Schrader, McCaul and Bilirakis in introducing this bipartisan legislation.”
“The drug supply chain is global and to ensure Americans have access to medicines, we must better understand where our drugs are coming from and how manufacturers will handle disruptions,” said Rep. Schrader. “This bipartisan bill will help to prevent prescription drug shortages by mitigating interruptions in the drug supply chain like we are seeing with the outbreak of COVID-19 in China. Commonsense legislation like this ensures that Americans can access the medications that they need for themselves and their families.”
“Fortifying our drug chain will help ensure critical access to necessary medications, especially during emergency situations when the current system has often experienced strain,” said Rep. Bilirakis. “This common sense, necessary step is integral to protecting public safety and I urge my colleagues to join this bipartisan effort to expedite passage.”