This is a press release from the Office of Congressman Buddy Carter.
Rep. Earl L. “Buddy” Carter (R-GA) introduced the Growing America’s Pharmaceutical Supply Act, a bill that will alleviate drug shortages by giving outsourcing facilities the certainty necessary to invest in producing these medications.
Currently, when a drug is listed on the Food and Drug Administration’s (FDA) drug shortage list, 503B outsourcing facilities are statutorily permitted to prepare compounded versions from bulk drug substances, also known as APIs. A drug may appear on this list for as little as one day or more than a year, making it a risky investment for outsourcing facilities to develop a drug that may be taken off the list, with no notice, before it reaches patients.
The Growing America’s Pharmaceutical Supply Act will address this issue by guaranteeing 503B outsourcing facilities 180 days, from the time a drug is listed on the FDA shortage list, to dispense the listed medication.
“There are more than 200 drugs actively in shortage in the United States, putting patients, public health, and national security at risk. 503B facilities are able to get these drugs to market quickly but must have the certainty needed to ensure their investment is worthwhile. By establishing a timeline for these facilities to dispense necessary medications, we will increase domestic drug development and help patients get the care they need when they need it,” said Rep. Carter.
The bill boasts strong support from hospital, patient, and pharmacy communities.
“The Children’s Hospital Association is proud to support the Growing America’s Pharmaceutical Supply Act to help address critical drug shortages for children. The 503b program, which this legislation supports, is a vital piece of this puzzle. Recently, 503b manufacturers supported the production of pediatric chemotherapy medication during a shortage and helped alleviate a pediatric albuterol shortage during a respiratory illness surge,” said Terri Lyle Wilson, Children’s Hospital Association’s Vice President of Pharmacy. “This legislation will incentivize scaled-up production to ease drug shortages, ensuring 503b manufacturers can afford the research and investment necessary to produce medication efficiently during a shortage. We appreciate Representative Carter’s leadership and look forward to continued collaboration for children’s health care.”
“OFA member facilities have worked with hospitals and physicians to provide them with gap supply on medicines in shortage ranging from life-sustaining nutrients for preterm infants, to liquid albuterol, even to lifesaving drugs for COVID patients during the pandemic. But as they strive to help, facilities have also faced challenges and risk in managing the uncertainty inherent in drug shortages. Congressman Carter’s legislation will enable more 503B facilities to mitigate more shortages, all with American-made medicines subject to rigorous FDA manufacturing standards. We applaud his commitment to ensuring that hospitals, doctors and their patients receive the treatments they need,” said Lee Rosebush, Chairman of the Outsourcing Facilities Association (OFA).
“ASHP supports the GAP Supply Act, which provides 503B outsourcing facilities greater certainty needed to invest in compounding of products on FDA’s drug shortage list. This is an important policy solution to ensure patients have access to critical medications at risk of shortage,” said Tom Kraus, Vice President of ASHP Government Relations.
Read the full bill text here.
