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First on CNN: Klobuchar questions drug company behind 10-fold spike in price of lead poisoning antidote

By Meg Tirrell, CNN

(CNN) — The $32,000 cost of a crucial drug to treat severe lead poisoning drew ire from Democratic Sen. Amy Klobuchar, who wrote a letter to the chief executive of the drug’s maker on Thursday, seeking answers on how the company reached its price.

The letter followed CNN’s reporting Wednesday that the drug, made by Rising Pharmaceuticals, costs almost 10 times more than an imported version of the medicine from France, which the US Food and Drug Administration had allowed to be used in the US while the drug was in shortage.

Toxicologists told CNN that the price can make it difficult for hospitals to stock the medicine, called calcium disodium EDTA, potentially leading to delays of days when patients need urgent treatment. EDTA is used for the most severe cases of lead poisoning, when blood lead levels get high enough – including in children – that it can cause seizure, coma and brain swelling.

“Rising’s decision to price this generic injectable at ten times the price of the imported version from France is leading to avoidable and dangerous delays in patient treatment and compromising patient care,” Klobuchar, D-Minnesota, wrote in the letter to Rising CEO Vimal Kavuru. “Please explain the reasoning behind Rising Pharmaceuticals’ decision to adopt a price for its generic that well exceeds the price of many expensive brand products on the U.S. market.”

The senator asked Kavuru to list the factors that went into the pricing decision and whether the company was seeking to capitalize on the shortage of the drug in the US. She also sought answers about the effects on patient care and why a US version must be priced so much higher than a French one.

Klobuchar, who’s chair of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights, also recently sent a letter to FDA Commissioner Dr. Robert Califf urging the agency to address levels of toxic heavy metals in food for babies and young children in the wake of reports of lead exposures from contaminated pouches of cinnamon applesauce.

The FDA’s investigation of that matter continues, with more than 60 cases reported among children under the age of 6 as of Tuesday. The lead is suspected to have been from tainted cinnamon from a distributor in Ecuador.

“Lead is toxic to people of all ages, but can be especially harmful to infants and young children,” Klobuchar wrote to the FDA, along with several colleagues from Congress.

Children can also be exposed to lead from paint in older homes, and exposure can build up over time until, in rare cases, a drug like EDTA becomes urgently required.

If a hospital doesn’t have the medicine in stock, it can take a few days to find it, Dr. Diane Calello, medical and executive director of the New Jersey Poison Control Center, told CNN.

“Two or three days when you have a child who’s in a coma or having seizures or is really critically ill is intolerably long,” she said.

Rising didn’t respond to CNN’s requests for comment.

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