Apr 17, 2012
In February, ASCO worked to raise awareness about the shortage ofpreservative-free methotrexate; supported the legislative efforts of Senator Amy Klobuchar (D-MN) and Representatives Diana DeGette (D-CO) and John Carney (D-DE) to address the crisis; and delivered recommendations for a long-term solution at an FDA news briefing.
ASCO’s outreach related to the methotrexate shortage resulted in coverage of the issue and the Society’s perspective by numerous media outlets, including the New York Times (“Supply of a Cancer Drug May Run Out Within Weeks,” February 10, 2012), ABC News (“Critical Shortage of Children’s Leukemia Drug,” February 10, 2012), Forbes.com (“Proof of the Failure of Free Markets in Medicine,” February 12, 2012), the Associated Press (“Doctors Urge More Production of Scarce Cancer Drug,” February 13, 2012), and USA Today (“FDA: Shortage of Kids’ Cancer Drug Can Be Averted,” February 14, 2012). ASCO President Michael P. Link, MD, was quoted in several articles, speaking on behalf of the Society and affected patients and families.
ASCO in Action reported that Senators Klobuchar, Robert Casey (D-PA), and Susan Collins (R-ME) introduced an amendment to the Surface Transportation Reauthorization Act to prompt consideration of the issue. Dr. Link expressed ASCO’s support for Senator Klobuchar’s push for legislative action in the Senate. ASCO is also working with Rep. DeGette on opportunities to move her legislation quickly through the House.
“ASCO is very grateful for Senator Klobuchar’s continuing leadership and focus on this issue, particularly in quick response to the dire circumstances around the shortage of preservative-free methotrexate,” Dr. Link said in a February 15 statement. “We hope that her amendment will help ensure prompt congressional action on long-term fixes needed to avoid these crises in the future.”
Positive results
Outreach by ASCO, the Children’s Oncology Group, the American Society of Pediatric Hematology/Oncology, and Senator Klobuchar to the companies producing methotrexate produced a positive result: two companies worked to increase production of the drug, helping to avert the shortage. The FDA also reviewed in short time an application by a third company to begin producing preservative-free methotrexate.
On February 21, the FDA held a press conference announcing that shortages of methotrexate and Doxil had been resolved and invited Dr. Link to speak on behalf of ASCO. Dr. Link praised the agency’s efforts, but urged Congress to pass legislation as quickly as possible to enact permanent solutions:
“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.
“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.”
During the press conference, Dr. Link urged Congress to appoint a House-Senate bipartisan panel to agree on legislation that would include the following elements:
ASCO’s outreach related to the methotrexate shortage resulted in coverage of the issue and the Society’s perspective by numerous media outlets, including the New York Times (“Supply of a Cancer Drug May Run Out Within Weeks,” February 10, 2012), ABC News (“Critical Shortage of Children’s Leukemia Drug,” February 10, 2012), Forbes.com (“Proof of the Failure of Free Markets in Medicine,” February 12, 2012), the Associated Press (“Doctors Urge More Production of Scarce Cancer Drug,” February 13, 2012), and USA Today (“FDA: Shortage of Kids’ Cancer Drug Can Be Averted,” February 14, 2012). ASCO President Michael P. Link, MD, was quoted in several articles, speaking on behalf of the Society and affected patients and families.
ASCO in Action reported that Senators Klobuchar, Robert Casey (D-PA), and Susan Collins (R-ME) introduced an amendment to the Surface Transportation Reauthorization Act to prompt consideration of the issue. Dr. Link expressed ASCO’s support for Senator Klobuchar’s push for legislative action in the Senate. ASCO is also working with Rep. DeGette on opportunities to move her legislation quickly through the House.
“ASCO is very grateful for Senator Klobuchar’s continuing leadership and focus on this issue, particularly in quick response to the dire circumstances around the shortage of preservative-free methotrexate,” Dr. Link said in a February 15 statement. “We hope that her amendment will help ensure prompt congressional action on long-term fixes needed to avoid these crises in the future.”
Positive results
Outreach by ASCO, the Children’s Oncology Group, the American Society of Pediatric Hematology/Oncology, and Senator Klobuchar to the companies producing methotrexate produced a positive result: two companies worked to increase production of the drug, helping to avert the shortage. The FDA also reviewed in short time an application by a third company to begin producing preservative-free methotrexate.
On February 21, the FDA held a press conference announcing that shortages of methotrexate and Doxil had been resolved and invited Dr. Link to speak on behalf of ASCO. Dr. Link praised the agency’s efforts, but urged Congress to pass legislation as quickly as possible to enact permanent solutions:
“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.
“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.”
During the press conference, Dr. Link urged Congress to appoint a House-Senate bipartisan panel to agree on legislation that would include the following elements:
- FDA needs to receive 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.
- The role of economics must be addressed 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.