December 11, 2023 - WASHINGTON - Last week, U.S. Senator Amy Klobuchar (D-MN) sent a letter to Rising Pharmaceuticals President and CEO Vimal Kavuru calling on the company to explain Rising’s recent pricing decision on Edetate Calcium Disodium Injection, a drug used to treat lead poisoning. The U.S. Food and Drug Administration (FDA) gave Rising approval to manufacture and commercially produce this drug to alleviate a shortage of this critical treatment. Recent media reports indicate that Rising Pharmaceuticals has set the price for this critical medication at a higher price than the average name-brand injectable sold in the U.S. and ten times the amount of the same generic product in France, leading to shortages as hospitals cannot afford to keep it in stock. 

“Rising’s decision to price this generic injectable at $32,000 per course of treatment — ten times the price of the imported version from France — has left hospitals reportedly unable to afford to keep the drug in stock,” wrote Klobuchar. 

“Unfortunately, your company’s pricing decision is not supportive of Americans diagnosed with elevated blood lead levels who now must wait days, an intolerably long time, before their hospital is able to source this critical drug,” continued Klobuchar. 

As Chair of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights, Klobuchar has long led efforts to lower drug prices. Provisions from Klobuchar’s bill to empower Medicare to negotiate prescription drug prices and unleash the power of Medicare Part D’s 50 million seniors to help lower drug prices for all Americans were signed into law as part of landmark legislation passed last year. This past August, Klobuchar released a statement following the announcement of the first ten drugs subject to Medicare price negotiations. 

In May 2023, Klobuchar and Senator Bernie Sanders (I-VT) reintroduced the Cutting Medicare Prescription Drug Prices in Half Act, which would allow Medicare to pay the same prices for prescription drugs as the Veterans’ Administration (VA). The VA's prices for prescription drugs are roughly half the amount paid by Medicare Part D for the same products. 

This past April, Klobuchar, Senator Peter Welch (D-VT), and 28 of their colleagues introduced the Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act which would allow the Department of Health and Human Services (HHS) to expand its program to negotiate lower drug prices for Medicare Part D beneficiaries.

In March, Klobuchar and Senator Cortez Masto (D-NV) introduced the Lower Drug Costs for Families Act, legislation to lower prices by extending the inflation rebates in the Inflation Reduction Act and further protecting consumers from price-gouging by pharmaceutical companies.

In February, two of Klobuchar and Senator Chuck Grassley’s (R-IA) bipartisan bills that promote competition and reduce drug prices - the Preserving Access to Affordable Generics and Biosimilars Act and the Stop STALLING Act - passed the Senate Judiciary Committee by voice vote. 

The Preserving Access to Affordable Generics and Biosimilars Act would limit anticompetitive “pay-for-delay” deals that prevent or delay the introduction of affordable follow-on versions of branded pharmaceuticals.  

The Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics  (Stop STALLING) Act would deter pharmaceutical companies from filing sham petitions with the FDA in order to interfere with the approval of generic and biosimilar medicines that compete with their own brand products, a tactic that delays patient access to affordable medications.

In June 2022, Klobuchar and Representative Katie Porter (D-CA) urged the Department of Justice (DOJ) and Federal Trade Commission (FTC) to examine the parallel price increases for two commonly-used blood thinner medications: Janssen Pharmaceuticals’ Xarelto and Bristol-Myers Squibb (BMS)-Pfizer’s Eliquis. The lawmakers expressed concern that lockstep pricing practices and the general lack of competitive behavior exhibited by these drug sellers may constitute potential unlawful conduct.

Full text of the letter is available HERE and below:

Dear Mr. Kavuru:

I write regarding reports of a pricing decision made by Rising Pharmaceuticals that is leading to compromised patient care for those suffering from the most severe cases of lead poisoning. Specifically, Rising has priced its Edetate Calcium Disodium Injection, a generic drug to treat elevated blood lead levels, at $32,000 per course of treatment, reportedly leading to hospitals no longer being able to afford to stock this drug.

The U.S. Food and Drug Administration gave Rising Pharmaceuticals approval to manufacture and commercially produce this drug to alleviate a shortage of this critical treatment. 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.

Your company’s September 19 announcement of the opening of its previously closed U.S. manufacturing facility, which produces calcium disodium ethylenediaminetetraacetic acid (EDTA), stated that “Rising Pharmaceuticals is proud to play a significant role supporting the healthcare system.” However, Rising’s pricing decision does not appear to support this goal. As a result of Rising’s actions, Americans diagnosed with elevated blood lead levels must wait days - an intolerably long time - before their hospital is able to source this critical drug.

Rising Pharmaceuticals boasts one of the broadest portfolios of any U.S. generics company, producing more than 180 commercialized generic medicines. Rising’s website states that the company is “always looking ahead to continue providing new and affordable generic medications of the highest quality.” Given the company’s broad revenue base and apparent focus on the affordability of its products, 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.

In your response, please answer the following questions:

1. What were the biggest factors influencing Rising Pharmaceuticals’ decision to price its calcium disodium EDTA at $32,000 per course of treatment, a higher price than the average name-brand injectable sold in the U.S.?
   
   
2. Is Rising Pharmaceuticals pricing its calcium disodium EDTA to capitalize on the shortage of this drug in the United States?
   
   
3. Does Rising Pharmaceuticals’ pricing decision of $32,000 per course of treatment compromise timely access to treatment for patients with elevated blood lead levels who need treatment? Is Rising Pharmaceuticals surprised by this outcome and does the company find this pricing ensures efficacious distribution to the public?
   
   
4. Why has Rising Pharmaceuticals chosen to not follow a similar U.S. pricing strategy as that of a manufacturer of calcium disodium EDTA in France selling the same product in the U.S. market? Would Rising Pharmaceuticals be able to make a healthy profit off of its U.S. production of calcium disodium EDTA if it followed a similar U.S. pricing strategy for calcium disodium EDTA as that of its competitor product made in France?
   
   
5. As a company with such a broad and large product portfolio, please explain why Rising’s calcium disodium EDTA product must be priced at ten times the price of the competitor generic imported from France.
   
   
6. Does Rising Pharmaceuticals believe they are helping to provide timely access to Edetate Calcium Disodium Injection, as stated in the September 19 announcement, compared to before there was a shortage of this medication?
   
   
7. In deciding its price that is reportedly leading to dangerous delays in patient access to calcium disodium EDTA, how did Rising Pharmaceuticals factor in the circumstances that maximize the clinical effectiveness of the drug?
   
   
8. Why is this generic drug that was developed decades ago priced at ten times the amount of the same generic product in France? France pays more for generics on average than other comparable European countries.

I know from the statements on your website that your company understands the importance of prescription drugs being affordable and accessible. We must optimize the market for patients and our health system. I look forward to your response. 
Source: Senator Amy Klobuchar