Shortages of important prescription medications are becoming serious problems for many parts of the country, and New York Senator Charles Schumer says the only way to fix the problem is to make improvements to the industry's supply chain.
According to a release from the Democrat's office, Schumer plans to introduce legislation that would allow the U.S. Food and Drug administration to work better with drug manufacturers to avoid shortages that affect hospitals, doctors and patients alike. This partnership, along with an early notification mandate, he said, would help find new sources that allow manufacturers to overcome supply chain management issues.
The sooner the FDA is notified of potential shortages, the faster the two sides can begin working together toward a solution, Schumer's release said.
"Most importantly, patients and medical personnel cannot be the last to know when an important drug will be unavailable to them, and this plan to minimize that risk by creating an early warning system from drug makers to the FDA makes eminent sense," the senator said.
Schumer is calling his proposed bill the Preserving Access to Life-Saving Medications Act, which he recently introduced during a press event at Hematology Oncology Associates in Syracuse, New York.
According to a recent PharmTech report, the FDA has already taken steps in this direction. Earlier this month, the agency issued an interim final rule that made it mandatory for drug manufacturers to notify organizations that only have to disclose when shortages of certain products are imminent.
The rule may only apply to certain organizations, but it's a step in the right direction, PharmTech contributor Erik Greb wrote.
"As any supply chain professional knows, having one source of a crucial item is far from an ideal situation," Greb wrote for the news provider. "If a drug is crucial but not profitable, we may not see new sources spring up to provide additional supply chain security. But FDA’s initiatives promise to ease the threat of drug shortages and reduce patients’ suffering."
Also, the FDA is developing a database to track drug shortages and highlight where supply chain improvements are necessary. The database will contain the number of shortages, how serious the incidents are and what the FDA is doing or can do to help fix the problem.