FDA Slows Shortages of Two Cancer Drugs

The Food and Drug Administration, along with private manufacturers, announced efforts on Tuesday that they say will stave off shortages for two cancer drugs.

The FDA sped up approval of a new formulation of methotrexate, a drug used to treat children’s cancer, made by  APP Pharmaceutical. It said another company that makes the drug, Hospira, had pushed out extra doses to address the ongoing shortage.

The FDA also said it would temporarily allow imports of an Indian-made drug called Lipodox, which is not yet approved in the United States but can be used as a substitute to cover shortages of the cancer drug Doxil.

“Temporary importation of unapproved foreign drugs is considered in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs,” the FDA said in a statement.

“We must aggressively address the often life-threatening challenge of drug shortages,” FDA Commissioner Margaret Hamburg said at a news conference. “The FDA has been actively and aggressively working with industry … to ensure treatment and therapies get into the hand of those who need them, when they need them.”

In an unusually coordinated move, White House Deputy Chief of Staff Nancy-Ann DeParle wrote a blog post trumpeting the Obama administration’s October executive order asking drugmakers to voluntarily report shortages. Since that effort, FDA says drug shortage notifications have increased sixfold.

“Since President Obama signed his executive order, FDA has prevented 114 drug shortages. In part, this resulted from the administration’s call for voluntarily notification to the FDA of potential shortages,” wrote DeParle. “Congress still has not acted on legislation that would make notifying the FDA of potential drug shortages mandatory in more cases. And we know that there is no one single cause of drug shortages: Everyone has a role to play to prevent shortages from happening.”

The FDA also borrowed a page from the White House’s health reform law playbook, showcasing the story of child who might lose access to life-saving cancer drugs to bring a human element to the problem of drug shortages.

“Just last week we saw the news about the shortage, and we asked my son’s clinic if we should be worried about Nate,” said Sara Stuckey, of Lincoln, Ill. Stuckey's 6-year-old son Nate has acute lymphoblastic leukemia and needs methotrexate to live. “The head nurse said there was enough for the next treatment, but after that we should be concerned.”

Hamburg called on Congress to pass one of the bipartisan bills introduced in the House and Senate to slow drug shortages by requiring manufacturers to tell the FDA when there are potential shortages, among other measures.

“The proposed legislation would really put into law a broader reporting framework, which we think will have real benefits,” Hamburg said. She added that since many drug ingredients come from around the globe, FDA “must have the ability, the resources, the dollars and people to be able to go out around the world to ensure products are being made in ways that accord with our standards to ensure safety and quality.”

Congress is in the process of reauthorizing a program through which private industry pays fees to the FDA to have drug products approved. It is a likely vehicle for any drug-shortage legislation to hitch a ride.