Legislation may prevent drug shortages
Published 7:04 am Wednesday, July 11, 2012
WASHINGTON, D.C. – U.S. Sen. Amy Klobuchar announced Monday her bipartisan provisions to help prevent drug shortages have been signed into law.
The Food and Drug Administration Safety and Innovation Act includes language by Klobuchar that requires early warning notification and gives the FDA the tools it needs to stop critical drug shortages. The bill also includes Klobuchar’s medical devices provisions to curb regulatory burdens that unnecessarily delay new, life-saving medical devices from reaching the market without compromising consumer safety.
“Thanks to the hard work of patients, hospitals and pharmacists across Minnesota, these common-sense reforms to help prevent drug shortages from wreaking havoc on families’ lives are now the law of the land,” Klobuchar said. “I will continue to work to ensure that all patients have access to the lifesaving drugs they need to stay healthy.”
The FDA prevented nearly 200 drug shortages in 2011 due to voluntary early notifications from companies, up from 38 in 2010. During a recent FDA workshop, FDA officials said that the rise in preventions is due to increased pressure from Klobuchar and other members of Congress.
The agreement will also direct the FDA to expedite inspections and reviews of manufacturing sites and new products that could be helpful in addressing a drug shortage, and to keep detailed records of previous drug shortages and the actions taken to prevent them. It will also establish a task force to create a strategic plan to improve communication within the FDA and with public stakeholders, as well as commission a report on price gouging and how pricing structures factor into drug shortages.