At a Feb. 21 press conference held by the Food and Drug Administration to discuss the latest shortage of methotrexate, ASCO President Michael P. Link, MD, praised the agency’s efforts to address critical shortages, but said Congress needs to develop legislation that would result in permanent solutions.
“FDA, our pharmacists, physicians and manufacturers have cobbled together patches, but we cannot continue to practice medicine from crisis to crisis,” Dr. Link said. “Many other drugs remain in shortage and we need permanent solutions.”
Dr. Link urged Congress to appoint a bipartisan panel to develop legislation that would address the economic issues that hamper supply. ASCO believes a long-term solution must include three components:
FDA needs to information on manufacturing delays or market withdrawals as far in advance as possible. The agency should have reliable information on existing supplies of these drugs and be able to identify counterfeit or unapproved drugs.
A permanent solution would have to address the role of economics, because the market currently is unable to respond appropriately when there is high demand and short supply. Pricing and incentives should ensure that manufacturers incorporate redundancies and contingency planning in their production.
The generic user fee plan must be passed to provide FDA with resources to review applications in a timely way and enable the agency to complete inspections and work with companies to address issues that might otherwise lead to shortages.
“It is for all cancer patients that we must make permanent changes that address the root causes of the ongoing drug shortage problem,” Dr. Link said.
Visit ASCO Connection to view the full text of Dr. Link's remarks.
Use ASCO's ACT Network to contact your member of Congress and urge them to address the growing drug shortages crisis.
L to R: FDA Commissioner Margaret Hamburg, MD; Sandra Kweder, MD, deputy director, FDA Office of New Drugs; Sarah Stuckey, mother of a 6-year-old cancer patient; Len Lichtenfeld, MD, deputy chief medical officer, American Cancer Society; ASCO President Michael P. Link, MD; Peter Adamson, MD, chair, Children’s Oncology Group; Mitchell L. Ehrlich, vice president, quality, IV drugs and operations, Fresenius Kabi USA; F. Michael Ball, CEO, Hospira Inc.