The U.S. Senate voted today to reauthorize the Federal Drug Administration (FDA) Safety and Innovation Act that features provisions based on legislation Senator Kent Conrad strongly supported to increase consumer awareness and preparedness in the event of potential shortages of certain life-saving prescription medications.
Senator Conrad said the bipartisan provision included in the FDA bill requires drug manufacturers to provide notice when a discontinuance, interruption, or other adjustment of the manufacture of a drug would likely result in a shortage of the drug.
"The challenges confronting individuals with life-threatening illnesses are great enough without having to deal with a disruption in their treatment," Senator Conrad said. "This provision takes important steps to ensure that health care professionals and patients are equipped with as much information as possible as they put in place treatment plans to ensure the best possible health outcomes."
The Senator has heard from an increasing number of North Dakota providers and patients about the number and severity of drug shortages in the state. The medications primarily impacted include older generic drugs, like cancer drugs, as well as anesthetics used for surgery and drugs for emergency medicine.
This provision is a positive first step in resolving these challenges, which arise from a number of reasons.
The broader FDA Safety and Innovation Act reauthorizes the drug and device user fee programs, creates user fee programs for generic drugs and generic biologic drugs and permanently authorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, both of which encourage manufacturers to conduct pediatric studies of their products.
The Senate voted 96-1 in favor of the bill.