WASHINGTON, D.C. – Today, U.S. Senator Angus King (I-Maine) joined several of his colleagues to call on the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) to investigate the impact that selling medicine in large one-size-fits-all vials has on the federal health care system and public health. The letter follows a New York Times report that nearly $3 billion is wasted annually on discarded cancer medicines because many drug companies only distribute the drugs in large vials that hold too much medication for most patients.

“Since Medicare, and many private insurance companies, charge patients co-payments equal to as much as 20 percent for prescription drugs, patients are paying more in out-of-pocket costs for drugs that end up in the trash bin,” the Senators wrote.  “What makes this situation even more alarming is the fact that patients, and the federal government, are already struggling with exorbitantly high prices for prescription drugs. Over the past few years, there have been a number of highly publicized incidents in which prices for certain drugs inexplicably skyrocketed – resulting in significantly higher costs for families, insurers, and the federal government, as well as limiting access for those in need.”

Senators signing on to today’s letter include U.S. Senators Dick Durbin (D-IL), Barbara Mikulski (D-MD), Sherrod Brown (D-OH), Bernie Sanders (I-VT), Sheldon Whitehouse (D-RI), Kirsten Gillibrand (D-NY), Tammy Baldwin (D-WI), Bill Nelson (D-FL), Al Franken (D-MN) and Amy Klobuchar (D-MN).

The complete text of the letter is available below.

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March 10, 2016

The Honorable Robert Califf, M.D.

Commissioner

United States Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

The Honorable Andrew M. Slavitt

Acting Administrator

Centers for Medicare and Medicaid Services

Hubert H. Humphrey Building

200 Independence Avenue, SW Room 445-G

Washington, DC 20201

Dear Commissioner Califf and Acting Administrator Slavitt:

            Last week, The New York Times reported that the federal Medicare program, as well as private health insurers, are wasting nearly $3 billion annually on cancer medicines that end up being discarded due to drug companies distributing expensive drugs in vials that contain more medicine than the average patient needs. We write today to both bring your attention to this very troublesome situation and ask you to investigate the impact this practice has on federal healthcare programs, including the Medicare program, and patients’ access to the medicines. 

            A recent study published in BMJ, formerly the British Medical Journal, by a group of researchers at Memorial Sloan Kettering Cancer Center found that many drug companies making cancer medications exclusively sell one-size-fits-all vials in the United States, which result in patients paying thousands of dollars for medicines that they do not need or receive. For example, Velcade, a drug sold by Takeda Pharmaceuticals for the treatment of multiple myeloma and lymphoma, is only sold in 3.5-milligram vials – which is enough medicine to treat a 6 feet 6 inches tall person weighing 250 pounds – with a price-tag of $1,034. Many of these drugs have a very short shelf-life once they have been opened (oftentimes just a few hours), meaning the unused portions of the medicine must be thrown away if not used immediately.

The result of these excessively large one-size-fits-all vial sizes is that insurance companies and federal healthcare programs, like Medicare, are paying drug makers in excess of $1.8 billion annually for discarded quantities of these medications and then another $1 billion on markups to doctors and hospitals for these drugs. Since Medicare, and many private insurance companies, charge patients co-payments equal to as much as 20 percent for prescription drugs, patients are paying more in out-of-pocket costs for drugs that end up in the trash bin. 

            What makes this situation even more alarming is the fact that patients, and the federal government, are already struggling with exorbitantly high prices for prescription drugs. Over the past few years, there have been a number of highly publicized incidents in which prices for certain drugs inexplicably skyrocketed – resulting in significantly higher costs for families, insurers, and the federal government, as well as limiting access for those in need. At the same time, the largest pharmaceutical companies together are reportedly earning $80-$90 billion per year in profits, which represents a higher margin than many other industries, and are spending more money on marketing than on investing in research and development. 

The Centers for Medicare and Medicaid Services (CMS) is the federal agency responsible for administering the Medicare program (which is doling out large sums of money for excessive amounts of drugs that never get used). The Food and Drug Administration (FDA) is responsible for reviewing all medical products to ensure that the public health is advanced and protected. We ask CMS and FDA to investigate the impact that this practice – whereby drug companies only sell expensive medicines in one-size-fits-all vials containing more than what the average person needs – has on our federal healthcare programs, including Medicare, and the public health, including access to medicine. We also request your recommendations on how Congress and the Administration might work together to address this problem, which is unnecessarily costing taxpayers billions of dollars every year. We would request a response to this letter by Monday, March 21, 2016.

Thank you for your immediate consideration of this request.

Sincerely,

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