Amid low supplies of some chemotherapy drugs, healthcare groups and members of Congress are pushing the Food & Drug Administration to alleviate the shortages.
More healthcare leaders and lawmakers are expressing their alarm at the shortage of some cancer drugs.
Hospitals and health systems have been wrestling with shortages in certain drugs for weeks, which have left some patients without medication or delayed treatments. Now, more health leaders are calling for action to address the problem.
The American Society of Clinical Oncology, which has been closely tracking the cancer drug shortage, is asking lawmakers to support a letter to Robert Califf, the commissioner of the Food and Drug Administration.
U.S. Reps. Ami Bera, D-Calif., Brian Fitzpatrick R-Pa., Derek Kilmer D-Wash., and Mike Kelly, R-Pa., are circulating a letter to fellow House members. They’re petitioning the FDA to take action to mitigate current shortages and prevent future shortages. The ASCO is asking lawmakers to sign onto the letter by May 31.
Chemotherapy drugs are among the five biggest drug shortages in the country through March 31, according to data from the University of Utah Drug Information Service.
The ASCO is advising clinicians on steps to extend their dwindling supplies of cancer drugs, including reducing dosages or extending cycles between treatments when it’s clinically acceptable. For example, if a drug such as platinum is recommended every three or four weeks, clinicians should move patients to a four-week cycle if possible.
Providers should also consider offering referrals to patients who are emotionally affected by shortages, the ASCO says.
'Mitigate this dire shortage'
U.S. Sen. Gary Peters, D-Mich., U.S. Sen. Debbie Stabenow, D-Mich., and U.S. Rep. Elissa Slotkin, D-Mich., sent a letter to the FDA commissioner last week urging “the Food and Drug Administration to do everything in its power to alleviate the strain on patients and prevent delays in life-saving treatments.”
“We recognize that this shortage – as with the majority of shortages involving generic drugs – are largely due to a broken economic system in the generic drug industry,” the lawmakers continued. “While Congress is actively working on long-term solutions to this longstanding problem, we ask that in the short-term, FDA utilize all of its existing authorities to mitigate this dire shortage.”
The lawmakers are calling for the FDA to expedite approval of other suppliers and to allow the temporary importation of alternate products.
Critics say the shortages of generic drugs stem from manufacturers not investing enough to produce generics, which are less profitable. Some healthcare leaders are also calling for increased federal reimbursements for the manufacture of generic drugs.
The Leukemia & Lymphoma Society has been closely monitoring the shortages and has been meeting with key leaders on the issue.
Gwen Nichols, chief medical officer of The Leukemia & Lymphoma Society, said in a statement that she has been working with companies to get approvals to manufacture drugs such as nelarabine that are in critical shortage.
“Blood cancer drug shortages are a significant problem for our patients and their families who rely on these life-saving therapies to treat their disease, as well as to provide them the potential to return to what they consider a normal life — which could be as simple as a walk with their families or running a marathon,” Nichols said in a statement.
'Public health crisis'
Amanda Fader, professor of gynecology obstetrics and oncology at Johns Hopkins School of Medicine, told WJLA-TV that pharmacists are taking steps to ensure “every drop of chemotherapy” is used.
“This is becoming a public health crisis,” Fader told WJLA. “Imagine if like 12 or 14 antibiotics were all on shortage at the same time. This is what we’re dealing with in cancer medicine now.”
Lee Health, a public hospital system in Florida, is dealing with a lack of cancer drugs, the Naples Daily News reported. “Big cancer centers, little cancer centers, doctors’ offices,” Tina Gegeckas, director of oncology pharmacy for Lee Health, told the Naples Daily News. “We are being affected the same.”
The Michigan Health & Hospital Association said its members are seeing shortages of cisplatin and carboplatin, which are used to treat bladder, lung, ovarian and testicular cancers. Those shortages are affecting treatments, the group said.
Kaiser Permanente, like other health organizations, told KCRA-TV that the system is dealing with low supplies of cisplatin. The Sacramento TV station profiled a patient with bile duct cancer who is seeing delays in treatment.
The American Cancer Society issued a warning earlier this month about shortages of some chemotherapy drugs, including treatments for triple-negative breast cancer, ovarian cancer and leukemia. Some of the drugs that are in short supply don’t have effective alternatives.
“The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” Karen Knudsen, CEO of the American Cancer Society, said in a statement.
The Society of Gynecologic Oncology has recommended providers should reserve supplies for patients who will get the most benefit and to ration dosing when possible. The organization also suggested lengthening the time period between treatment cycles when possible.
Part of the problem stems from a disruption involving Intas Pharmaceuticals, an Indian firm that’s a key supplier of three chemotherapy drugs - methotrexate, carboplatin and cisplatin - that aren’t easily replaced, The New York Times reported. The FDA spotted quality concerns and Intas temporarily halted production.
Other pharmaceutical companies have been unable to meet the demands for those drugs.
Tom Cotter, executive director of Healthcare Ready, a non-profit organization that helps health systems prepare for emergencies, told Chief Healthcare Executive® in a March interview that there needs to be greater visibility in the supply chain.
“I think people think there's more visibility and transparency than there actually is in the supply chain, especially in the healthcare sector,” Cotter said.