November 22, 2024
End Drug Shortages Act intro’d in Congress
Legislation expands sources FDA may draw from in declaring drug shortages
US Senator Tim Kaine (D-VA) has introduced — with APC’s support — the End Drug Shortages Act with Sen. Tom Cotton (R-AR) as a co-sponsor in the Senate. Representatives Abigail Spanberger (D-VA) and Adrian Smith (R-NE) introduced a companion bill in the House.
The bill, most importantly, requires the FDA to consider information from patients and healthcare professionals — yes, that includes pharmacists — when designating a drug shortage, rather than relying strictly on manufacturer claims.
It would also define the term “surge” as it applies to drug demand, and require drug manufacturers to notify the FDA when there is a surge in demand that’s likely to lead to a supply disruption.
Read the official press release from Sen. Kaine’s office.
“Yes, we are disappointed that, in order to garner bipartisan support, the bill omits the 180-day ‘tail’ for 503B outsourcing facilities to continue compounding once a drug comes off the shortage list,” said APC CEO Scott Brunner. “That long tail is needed to better incentivise 503Bs to prepare shortage drugs. But the bill still goes a long way to addressing some of our biggest concerns about the FDA’s current procedure for determining shortages” — an issue we focused on at Compounders on Capitol Hill.
Besides APC, the bill has the support of — are you ready? — the American Hospital Association, American Society of Health System Pharmacists, Angels for Change, Association of American Medical Colleges, Children’s Hospital Association, Federation of American Hospitals, Inova, Kaiser Permanente, National Community Pharmacists Association, UVA Health, Virginia Commonwealth University, and Vizient.
