Representative Buddy Carter (R-GA01) recently introduced the Growing America’s Pharmaceutical Supply Act, a bill that would alleviate drug shortages by giving outsourcing facilities the regulatory certainty needed to invest in producing these medications.
In a recent comment, Rep. Carter elaborated on the necessity of the bill, explaining how this regulatory uncertainty impacts more than just manufacturers. It actually hurts patients the most.
“There are more than 200 drugs actively in shortage in the United States, putting patients, public health, and national security at risk,” Carter warned. “503B facilities are able to get these drugs to market quickly, but must have the certainty needed to ensure their investment is worthwhile.”
For context, 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 removed from the list, without notice, before it reaches patients.
The Bill and its Support
The Growing America’s Pharmaceutical Supply Act aims to 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.
By guaranteeing this time window, facilities will be able to invest more in the research and infrastructure necessary to scale up production. Without the fear of a random shutdown, their work will remain unimpeded.
Since the bill’s introduction and announcement, it has received strong support from the hospital, patient, and pharmacy communities.
A notable example is the Children’s Hospital Association’s Vice President of Pharmacy, Terri Lyle Wilson, who expressed pride in supporting this bill and noted its positive impact on children’s healthcare.
“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,” Wilson explained. “We appreciate Representative Carter’s leadership and look forward to continued collaboration for children’s health care.”
