There’s been increasing attention to an important issue facing some cancer patients: shortages of potentially lifesaving drugs. There are several reasons for the sudden appearance of the issue, primarily production issues. Articles in the past week in the New York Times and USA Today have more details.
Where does the American Cancer Society stand? We asked Otis W. Brawley, M.D., Chief Medical Officer, to comment.
“The availability of cancer drugs can mean the difference between life and death for many cancer patients. As the nation’s leading cancer organization, the American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action NetworkTM (ACS CAN), are aware and very concerned about the accessibility of prescription drugs, especially chemotherapy agents, and the implications for cancer patients. This is an issue that the organizations continue to follow with great interest.
“There are many contributing factors to drug shortages, including shortages in the supply of raw material, manufacturing capacity constraints, and other factors such as regulatory requirements and business strategies. Unfortunately, although there is clearly a drug shortage problem, there is no obvious or clear solution because of the numerous contributing causes.
“As a first step in rectifying the problem, ACS CAN is supporting federal legislation that would provide the government and the public with better information about existing and potentially new shortages. The legislation, titled “Preserving Access to Life-Saving Medications Act” (S.296), has been introduced in the Senate by Senator Amy Klobuchar of Minnesota.
“This piece of legislation would require a prescription drug manufacturer to notify the Food and Drug Administration (FDA) of a discontinuance, interruption, or other adjustment of the manufacture of a drug that would likely result in its shortage. Specifically, the legislation requires: (1) six months’ notice of any discontinuance or planned interruption or adjustment; and (2) notice as soon as practicable after becoming aware of such interruption or adjustment in the case of any other interruption or adjustment. Advanced notification to the FDA will enable them to better track and manage drug shortage issues and will allow the government, business, providers, and the public to more systematically analyze and understand the causes and develop appropriate solutions to minimize shortages in the future.
“The Society and ACS CAN will continue to actively pursue avenues to address drug shortages to improve the treatment of cancer patients across the country.”