WASHINGTON, D.C. – U.S. Senator Amy Klobuchar today announced that her bipartisan provisions to help prevent drug shortages are now headed to the President’s desk to be signed into law. The House and Senate have both approved the final version of the Food and Drug Administration Safety and Innovation Act, which includes Klobuchar’s provisions to require early warning notification and give the FDA the tools it needs to stop shortages of critical drugs. The bill also includes Klobuchar’s medical devices provisions that would reduce regulatory burdens that unnecessarily delay new, life-saving medical devices from reaching the market without compromising consumer safety.
“These common-sense reforms will help ensure that patients have access to the lifesaving drugs they need to stay healthy and prevent drug shortages from wreaking havoc on families’ lives,” Klobuchar said.“I would like to thank all the patients, hospitals and pharmacists across Minnesota who worked so hard on this issue, and I will continue to work to ensure that this critical legislation is swiftly signed into law.”
The Food and Drug Administration Safety and Innovation Act includes a bipartisan drug shortages agreement Klobuchar helped forge that would require prescription drug manufacturers to give early notification to the Food and Drug Administration (FDA) of any incident that would likely result in a drug shortage. This is the key provision in the Preserving Access to Life-Saving Medications Act, legislation Klobuchar introduced with Sen. Bob Casey (D-PA) and cosponsored by Senator Susan Collins (R-ME) and 28 other senators. 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 also includes two other provisions similar to Klobuchar’s legislation: it would direct the FDA to expedite inspections and reviews of manufacturing sites or new products that could be helpful in addressing a drug shortage, and require the FDA to keep detailed records of previous drug shortages and the actions taken to prevent them. It would 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.
The Food and Drug Administration Safety and Innovation Act also includes key provisions from Klobuchar’s bipartisan legislation, the Medical Device Regulatory Improvement Act, that would help streamline the FDA’s regulation of medical devices by strengthening FDA’s current least burdensome requirements. This would ensure that when making regulatory decisions on medical devices, FDA focuses only on the relevant information during the decision-making process, considers appropriate alternatives to reduce the time, effort, and cost of reaching regulatory decisions, and uses all reasonable mechanisms to reduce review times when making these decisions. The bill also includes Klobuchar’s provisions to address FDA’s overly restrictive conflicts of interest requirements and requires an independent review of the FDA’s Center on Device and Radiological Health.