U.S. senators Amy Klobuchar (D-MN) and Susan Collins (R-ME) are urging their fellow lawmakers to quickly pass a bipartisan bill aimed at addressing the growing drug shortage problem in the U.S.
“The shortages of these vital drugs are causing serious problems around the country,” said Collins in a statement. “Our legislation aims to give the FDA the tools and information they need to prevent drug shortages.”
The Preserving Access to Life-Saving Medications Act, which Klobuchar introduced last year, would require drug companies to give FDA six months notice of any discontinuance, interruption, or other adjustment of a drug's manufacturing process that would likely result in a shortage. Notification would be required for adjustments related to raw materials supply, production capabilities and other reasons deemed appropriate by the HHS secretary.
A stakeholders group has called for exploring incentives such as tax credits for producing critical drug products or upgrading manufacturing plants. They also recommend an expedited approval pathway.