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March 05, 2016

Senators Take Up Case With FDA Following MSKCC Study

Surabhi Dangi-Garimella, PhD
Senators Amy Klobuchar (D-MN) and Jeanne Shaheen (D-NH) have sent a letter to the FDA urging the regulatory body to find efficient ways to distribute expensive cancer drugs.
A study published by researchers at the Memorial Sloan Kettering Cancer Center (MSKCC) and the University of Chicago urging the pharmaceutical industry to rethink its approach to packaging cancer drugs into a one-size vial to avoid drug wastage has set some political wheels in motion. Senators Amy Klobuchar (D-MN) and Jeanne Shaheen (D-NH) have sent a letter to newly elected FDA commissioner Robert Califf, MD, urging the regulatory body to find efficient ways to distribute these drugs.

Both senators have been very active with addressing the cost of prescription medications. Shaheen is a cosponsor of the Medicare Prescription Drug Price Negotiation Act, which would empower Medicare—on behalf of seniors enrolled in the program—to negotiate pricing for drugs covered under Medicare Part D, similar to commercial health plans.

In their letter addressed to Califf, the lawmakers wrote, “Cancer takes an emotional, physical and financial toll on patients and families. 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.”

A more efficient packaging of expensive specialty medications such as anticancer drugs is just one piece that can help solve the cost puzzle faced by our healthcare system. But it does lead us to think that out-of-the-box solutions that might necessitate foundational changes, might be an answer.  

In an interview with Morning Consult, Peter Bach, MD, the author of the above BMJ study from MSKCC, said, “Pharmaceutical companies aren’t evil. They’re for-profit companies in a system that’s been designed for them. They’re doing what they should do.” According to Bach, indication-specific pricing and quality-of-care–based reimbursement—policy moves that are actively being pursued by the healthcare industry—are just some of the undertakings that can help see the change.  

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