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ASCO President Addresses FDA at Drug Shortages Press Conference

Feb 22, 2012

At a February 21 press conference held by the Food and Drug Administration to discuss the problem of drug shortages, ASCO President Michael P. Link, MD, praised the agency’s recent efforts to resolve the critical shortages of methotrexate and doxil, but urged Congress to develop legislation that would result in permanent solutions. The full text of his remarks follows:

For pediatric oncologists like me, progress over the past 3 decades against cancer has been little short of miraculous. Childhood cancers that were uniformly fatal are now being cured. Almost 90% of children with acute lymphoblastic leukemia—the most common pediatric cancer—will become long term survivors.

This progress is due to better use of some of the earliest available anti-cancer drugs. Thus, the shortages of some of these drugs—such as methotrexate—are especially distressing. I can assure you that the conversation of telling parents about their child’s cancer diagnosis is very difficult. But the distress of this conversation was always alleviated somewhat because in most cases I was able to tell them about the very effective therapy that we had available, and the realistic chance that their child would be cured. This conversation has recently changed: telling parents that with years of research we have developed the recipe to treat their child’s cancer but that the essential ingredients are unavailable today is unimaginably painful.

While it is the crisis of drug shortages for children with cancer that has captured national attention in recent days, methotrexate—and many other off-patent drugs experiencing shortages—are not only used for children, but also are critical to our success in treating many adult patients with cancer. It is for all cancer patients that we must make permanent changes that address the root causes of the ongoing drug shortage problem.

These are truly tragic—and frustrating—circumstances, but many people are working to address them. The FDA has worked to avert shortages and manage those that do occur. Captain Valerie Jensen, associate director of the FDA drug shortage program, deserves special recognition for her leadership and responsiveness to this crisis. The president’s executive order last October importantly assigned additional resources to FDA’s work.

We also appreciate the companies that have made commitments to help fill the gaps. With methotrexate, a number of companies that are not major producers recently offered to increase production—a move that reassured many of us who were beginning to panic at being unable to treat a curable, but deadly, disease.

We would also not be where we are today without the children, families, clinicians and institutions that were willing to share their stories, and the reporters who have done an outstanding job covering this issue.

While the stories are mainly about disruptions in treatment, a number of research studies that could result in better treatments have either been discontinued or delayed because drugs used in the study are in shortage. So, today’s shortages not only jeopardize today’s care—it will slow the development of better treatments for tomorrow’s cancer patients.

FDA, our pharmacists, physicians and manufacturers have cobbled together patches, but we cannot continue to practice medicine from crisis to crisis. Many other drugs remain in shortage, and we need permanent solutions.

We appreciate the leadership of Senators Amy Klobuchar, Orrin Hatch, Robert Casey, and Susan Collins, and Representatives Diana DeGette, Thomas Rooney, and John Carney. Congress has convened hearings to understand the causes of drug shortages. Now is the time to enact lasting solutions quickly.

Congressional leadership should immediately appoint a bipartisan, bicameral group to consider all possible approaches and to develop legislation for permanent solutions to the cancer drug shortage crisis that can be considered by both chambers within 60 days.

The American Society of Clinical Oncology believes there are three critical elements that must be part of the long-term solution:

First, FDA needs to have information on manufacturing delays or market withdrawals as far in advance as possible. It is equally important—when we are near or in a shortage—to have reliable information on where available drug resides and be able to identify counterfeit or unapproved drugs.

Second, we have to address the role that economics plays in causing shortages. For a variety of reasons, the market is unable to respond in expected ways when there is high demand and limited supply of generic medications. Addressing this aspect of drug shortages—including pricing and incentives to ensure manufacturers incorporate redundancies and contingency planning in their production—is a necessary and critical aspect of any solution.

And third, the generic user fee plan must be passed to provide resources for reviewing applications in a timely way. This will also enable FDA to complete inspections and work with companies to address issues that might otherwise lead to shortages.

I am hopeful that we find the answers soon and return to the most pressing matter that should be facing us—providing the best possible care for our patients with cancer.
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