Leahy, Sanders, Welch Urge FDA to Swiftly Resolve Critical Drug Recall
Washington, October 18 – Today, Sens. Patrick Leahy (D-Vt.) and Bernie Sanders (I-Vt.) and Rep. Peter Welch (D-Vt.) urged the Food and Drug Administration (FDA) to swiftly resolve the recall of Natpara, a lifesaving drug used to manage blood calcium levels for people with a rare condition called hypoparathyroidism.
“For the more than 2,000 patients in the United States who rely on Natpara to manage their blood calcium levels, the shortage of available product has potentially dire health consequences. Untreated hypoparathyroidism can lead to heart failure and death. Patients across the country have already been hospitalized due to an inability to get Natpara, and we fear that as more patients run out of Natpara, the number of avoidable hospitalizations – or worse – may increase,” the letter said.
Natpara is manufactured solely by Takeda Pharmaceuticals and was recalled on September 5 due to a potential issue with rubber particulates from the injector pen contaminating the medicine.
“Despite the recall now lasting over a month, FDA has not shared any substantive information with patients about how long the recall may last, what steps are being taken to develop short- and long-term solutions, or other patient guidance,” wrote the members of Congress. “[O]ur constituents have repeatedly contacted FDA and been left confused as to when the drug may become available again, as well as how they should proceed in the meantime. Given that these patients depend on Natpara to prevent serious health complications, this is entirely unacceptable.”
“Let us be clear – we strongly support FDA’s critical mission to protect public’s health and use its recall authority to protect patients from potentially harmful products. However, we also believe that FDA’s responsibility to American patients includes a responsibility to be transparent when possible, a commitment that has not been fulfilled in this case,” the members said.
“It’s really scary,” said Vermonter Ryan Polly in an interview with NBC5 news about the recall. “Without this medication, I could be sitting at work, and the next thing I know, I could be having a seizure or my heart could stop. And I have five kids; I want to be around for my kids.”
The members urged FDA “to work with Takeda as expeditiously as possible to resolve the recall, to use the agency’s available drug shortage tools to potentially provide patients with other treatment options, and to ensure patients have full information about when the supply of Natpara will resume and what measures patients can take while they wait.”
To read the letter, click here.