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.
From the March 01, 2012 Issue of MM+M - Medical Marketing and Media
