Minn. hospitals encouraged by FDA's cancer drug approvals

Minnesota hospitals and clinics that treat cancer patients said Tuesday they are encouraged by news that two important cancer drugs will become more widely available to alleviate nationwide shortages.

The Food and Drug Administration announced it will allow a replacement drug for Doxil to be imported from a company in India on a temporary basis. Doxil is a brand-name drug used for ovarian, breast or bone marrow cancer.

The FDA also approved a new supplier for methotrexate, a drug used to treat children with a type of leukemia called ALL.

Pediatric oncologist Dr. Bruce Bostrom said methotrexate supplies have been stable at Children's Hospitals and Clinics of Minnesota. But he said doctors — and parents — have been watching the situation carefully.

"It's very concerning to us and even more concerning to the parents, because they've heard about all these drug shortages and they're losing sleep and they're calling us up," he said. "It's enough to worry about your child having leukemia — and have to worry about will the drugs be there to treat it."

Bostrom said Children's uses methotrexate every day and currently has about 150 leukemia patients in its care. Some parents have considered going to Canada to access the drugs, he said.

"Hopefully we are averting a major crisis by having a new supplier," Bostrom said.

While the preservative-free version of methotrexate has been available in Minnesota, Doxil has been harder to get. The manufacturer for the Johnson & Johnson drug had to stop production last summer because of quality concerns.

The company began a program called Doxil Cares to allocate what was left of the drug to patients already on it. But many Minnesota patients haven't been able to get it, said Jan Merriman, director of clinical and pharmacy services for Minnesota Oncology.

"We registered all of our patients, but only one or two of our patients was able to get any Doxil through the Doxil Cares program," Merriman said.

Before the shortage, Minnesota Oncology had 40-50 patients on Doxil, and many of them were in the later stages of the disease.

"It was very upsetting to us, and was even more upsetting to patients," she said.

Merriman said the FDA has been under pressure to approve importation of the same or similar drugs from other countries, and she said Tuesday's announcement could help the situation.

"That has been a suggestion out there, and kind of a criticism of the FDA for the past year or two — that they weren't moving faster," she said. "So that's great that they're kind of stepping up and smoothing the way for [importation]. That will be a big help."

For hospitals and clinics trying to keep their supplies intact for patients, the shortages have been a challenge.

"The logistics of just trying to coordinate knowing how many patients that need the medications, and trying to anticipate the need for future patients who would potentially walk through the door, and that compounded with actually trying to obtain the product, is really stressful on health care resources," said Darcy Malard Johnson, oncology pharmacy program manager for the University of Minnesota Medical Center, Fairview.

Malard Johnson said it's still unclear how soon the drugs from the new suppliers will be available to Minnesota hospitals.

Doxil and methotrexate aren't the only drugs in short supply. With any shortage, "we're trying to mitigate it so there is no impact to the patient," Malard Johnson said.

In the wake of the FDA's announcement, Sen. Amy Klobuchar, D-Minn., urged passage of legislation she's sponsoring aimed at preventing future drug shortages.

"Today's action underscores why Congress must pass critical legislation that will help prevent these types of shortages from wreaking havoc on families' lives," she said in a written statement.

(The Associated Press contributed to this report.)