House Democrats Launch Inquiry Into Nationwide Drug Shortages
WASHINGTON — Democrats on the House Committee on Oversight and Accountability are pressing some of the nation’s largest drug manufacturers for answers on why there are still intermittent and repeated shortages of cancer meds and other drugs.
Led by Rep. Jamie Raskin, D-Md., the ranking member of the committee, the panel’s Democrats on Wednesday sent letters to Pfizer Inc., Sandoz Inc. US, and Teva Pharmaceuticals USA Inc., requesting a briefing on the issue and information on what prompted the ongoing shortages.
Among the medications cited in the lawmakers’ letters are a number of cancer drugs, including carboplatin, cisplatin and methotrexate; the antibiotic amoxicillin; and stimulant medications such as Adderall.
In addition to the shortages themselves, which the Democrats noted could affect tens of thousands of patients across the U.S., the lawmakers said they are also concerned about reports of price gouging that has driven up the price of the medications when they are available.
The tone of their letter to Pfizer and its subsidiaries, major manufacturers of carboplatin, cisplatin and methotrexate, three generic drugs commonly used to treat cancer, was typical of all three.
“Hospitals and health care providers have struggled with the scarcity in supply of 15 different oncology drugs, including three commonly used generic cancer treatment drugs manufactured by Pfizer and its subsidiaries — carboplatin, cisplatin and methotrexate,” they wrote to Pfizer chairman and CEO Albert Bourla.
“The current oncology drug shortage affects the clinical decision making process, patient outcomes and quality of life, and without crucial oncology drugs, cancer patients face severe gaps in their treatments and an increased risk of severe, life-threatening complications,” they said.
“Generic oncology drugs, including carboplatin, cisplatin, and methotrexate, are used to treat a wide range of cancers. The current shortage of these drugs could affect up to 500,000 adult patients,” they continued.
“While the United States has experienced oncology drug shortages before, this shortage has been particularly acute,” they said. “At certain points in 2023, up to 90% of hospital systems lacked consistent access to these medications, and in many instances, oncology practices were forced to ration doses or provide less desirable alternatives to a patient’s recommended treatment.”
Sandoz Inc. US is one of the top manufacturers of powder amoxicillin, which has been in short supply since October 2022.
Last September, the company issued a statement attributing the antibiotic’s shortage to the marketplace and stating that the low price point for amoxicillin was causing manufacturers to exit the market, further exacerbating the shortage.
But in their letter to Karen Haruvi, president North America of Sandoz Inc. US, the Democrats ask for more granular details, such as when the company first recognized the shortage and what steps it took to address the situation,
They also want the company to outline the steps it has taken to ensure the drug’s affordability and to describe how it plans to prevent similar shortages in the future.
Finally, the Democrats ask all three manufacturers to “identify all issues relating to the supply chain, quality assurance, availability of raw materials and availability of labor affecting the production and distribution” of their products.
Teva Pharmaceuticals, the third letter recipient, is one of the largest manufacturers of Adderall.
The Food and Drug Administration formally announced a shortage of Adderall and its generic equivalents on Oct. 12, 2022, and since then, supply has not been sufficient to meet U.S. market demand.
An estimated 41 million ADHD patients rely on Adderall or its equivalents to treat ADD/ADHD.
“Our constituents share story after story detailing how hard it is to fill prescriptions for Adderall and that the shortage affects every element of their lives,” the Democrats said in a letter to Teva president and CEO Richard Francis.
“For example, previously capable students are now barely able to get passing grades and adults are forced to contact every local pharmacy in an attempt to obtain a medication that may be the difference between being productive and focused in the workplace or losing their livelihoods,” they said.
The new investigation is the second the Democrats have launched in recent years.
In 2021, they released a staff report concluding their most recent inquiry which revealed that pharmaceutical companies studied by the committee raised prices of common brand-name drugs by nearly four times the rate of inflation from 2016 to 2020.
The Democrats have given the drug manufacturers until March 6 to respond to their letters and “help determine root causes and practical solutions” needed to remedy shortages.
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