Bernie urges FDA to swiftly resolve drug recall

"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.”


In response to Takeda Pharmaceuticals recalling Natpara, a lifesaving drug used to manage blood calcium levels for people with a rare condition called hypoparathyroidism, Sen. Bernie Sanders and others recently urged the U.S. Food and Drug Administration (FDA) to swiftly resolve the recall as more patients become hospitalized due to lack of access to the drug. Takeda issued a recall in early September after discovering that the pen injector was contaminating the drug with rubber particles.

On Friday, Sens. Bernie Sanders and Patrick Leahy along with Rep. Peter Welch sent a letter to Acting FDA Commissioner Ned Sharpless urging his agency to swiftly resolve the recall for the thousands of patients who no longer have access to Natpara. Natpara is manufactured solely by Takeda Pharmaceuticals and is used to treat hypoparathyroidism, an uncommon condition that can result in abnormally low calcium levels in the blood and bones and to an increase of phosphorus in the blood.

In the letter addressed to Commissioner Sharpless, the legislators wrote, “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.

“Let us be clear – we strongly support FDA’s critical mission to protect the 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.”

On September 5, the FDA and Takeda announced that the company was issuing an immediate recall of all doses of Natpara due to rubber particulates originating from the rubber septum of the Natpara cartridge. During the 14-day Natpara treatment period, the septum is punctured by a needle each day to obtain the daily dosage of solution. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge.

The legislators continued, “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. On October 2, FDA informed Takeda that it was changing the recall to Class I, requiring all patients to return unused Natpara to the company, escalating fear and concern among patients. Patients need more information in order to make necessary health care decisions, but our 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.”

On September 24, Takeda announced that the company has been working with the FDA to develop a Special Use Program intended to support patients previously prescribed Natpara who are facing life-threatening complications as a result of discontinuation of the drug. But according to the legislators, the program is so small that it only provides help to approximately 1 percent of the patients who need Natpara.

The legislators concluded, “We therefore reiterate our request that FDA and Takeda leadership work closely together to provide as much information as possible on when the original issue resulting in the recall will be resolved and provide clear guidance for impacted individuals on what options are available to them. We ask that FDA immediately evaluate whether the patients originally intended to benefit from Takeda’s Special Use Program are able to do so. Finally, we urge FDA to take all steps within your administration’s authority to aid patients impacted by the recall and ensure that Natpara, or any safe and effective alternative, is made available as soon as possible.”


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