Following Release of New Report, Shaheen and Klobuchar Urge the Food and Drug Administration to Examine the Dosage Size of Cancer Fighting Drugs

March 03, 2016

**Drug makers distribute cancer fighting drugs in vials that hold too much for most patients; according to a new study released this week, Medicare and private insurers waste nearly $3 billion a year on leftover medication from these vials; this practice encourages waste and drives up the cost for patients that rely on these lifesaving drugs**

**In a letter to Commissioner Califf, Shaheen and Klobuchar urged the FDA to examine this practice and find a more efficient way to distribute this crucial medication**

(Washington, DC) – U.S. Senators Jeanne Shaheen (D-NH) and Amy Klobuchar (D-MN) have urged the Food and Drug Administration (FDA) to examine the dosage size of cancer fighting drugs. Drug makers distribute cancer fighting drugs in vials that hold too much for most patients. According to a new study released this week by the Memorial Sloan Kettering Cancer Center, Medicare and private insurers waste nearly $3 billion a year on leftover medication from these vials. This practice encourages waste and drives up the cost for patients that rely on these lifesaving drugs. In a letter to Commissioner Califf, Klobuchar and Shaheen urged the FDA to examine this practice and try to find a more efficient way to distribute this crucial medication.

“Cancer takes an emotional, physical and financial toll on patients and families,” the lawmakers wrote. “The current practice encourages waste and drives up costs for patients who rely on these lifesaving medications. Because the drugs used to treat cancer are expensive, even small amounts of leftover medication can be extremely costly for patients and the health system. Families fighting cancer should not have to worry about being able to afford the next dose of medication. We urge the FDA to examine this practice to see if there is a more efficient way to deliver this crucial medication to the patients that need it.”

The Medicare Prescription Drug Price Negotiation Act, legislation Shaheen has cosponsored, would empower Medicare to negotiate for the best possible price of prescription medication for America’s seniors who are enrolled in Medicare Part D. Current law only allows for bargaining by pharmaceutical companies and bans Medicare from doing so. The Safe and Affordable Drugs from Canada Act, also cosponsored by Shaheen, would help Americans access safe, affordable prescription drugs from Canada by requiring that the Federal Drug Administration establish a personal importation program that would allow individuals to import a 90-day supply of prescription drugs from an approved Canadian pharmacy.

The full text of the lawmaker’s letter is below:

Dear Commissioner Califf:

We are writing to express serious concern regarding an issue affecting millions of cancer patients. As reported recently in the New York Times, drug manufacturers are distributing drugs in vials that contain larger dosages than needed by the average patient, resulting in the excessive waste of highly-valuable drugs. This practice can lead to large medical bills for cancer patients, and can add to the growth of health care costs overall. Although the FDA has issued guidance regarding vial size and fill volumes, it is clear that unnecessary waste of these drugs continues. We urge the Food and Drug Administration (FDA) to take additional steps to address this important issue.

Cancer takes an emotional, physical and financial toll on patients and families. While new treatments and models of care are saving lives and improving quality outcomes, some patients continue to struggle to afford the cost of medication. Researchers at Memorial Sloan Kettering Cancer Center recently released a study showing the way drugs are currently packaged and distributed results in unnecessary waste and leads to higher costs. The study estimates Medicare and private insurers waste nearly $3 billion each year on leftover medication due to excessively large dosages.

When examining a drug for approval the FDA should explore additional tools to manage the dosage amount contained in a vial or other packaging. The current practice encourages waste and drives up costs for patients who rely on these lifesaving medications. Because the drugs used to treat cancer are expensive, even small amounts of leftover medication can be extremely costly for patients and the health system. By evaluating the amount of medication to be distributed per unit, the FDA can encourage drug manufacturers to offer more appropriate and cost-effective packaging.

Families fighting cancer should not have to worry about being able to afford the next dose of medication. We urge the FDA to examine this practice to see if there is a more efficient way to deliver this crucial medication to the patients that need it. Thank you for your attention to this important issue. 

Sincerely,