Michigan lawmakers urge action on chemo drug shortage

Washington ― Michigan's entire delegation in Congress came together this past week to urge the U.S. Food and Drug Administration to mitigate a shortage of chemotherapy drugs affecting Michigan hospitals and cancer patients, in part by permitting the temporary importation of alternate drugs.

The FDA has reported nationwide shortages of the drugs cisplatin and carboplatin that are often used to treat bladder, lung, ovarian and testicular cancers, among others, with shortages expected to last into June. The FDA also reported a shortage of methotrexate, another chemotherapy drug, in March.

One letter, sent Thursday by Michigan's Democratic senators, Debbie Stabenow and Gary Peters, and U.S. Rep. Elissa Slotkin, D-Lansing, urged FDA Administrator Robert Califf to try to alleviate the strain on patients and doctors.

"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 wrote. “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.”

A separate letter, led by U.S. Reps. Tim Walberg, R-Tipton, and Debbie Dingell, D-Ann Arbor, asked the FDA to explain how it's working with manufacturers to reduce the shortage, what flexibilities the FDA can give the drug makers to help them boost production quickly and how the agency is using temporary importation to bring other manufacturers into the market.

The drug scarcity has prompted Michigan hospitals and health systems to use alternative treatments, some of which may be less effective, and adjusting chemotherapy regimens to manage remaining supplies, according to the Michigan Health & Hospital Association.

“Drug shortages severely hamper a hospital’s ability to provide patients with the best treatment, while forcing hospitals to implement strategies that may increase the cost of care and sometimes do not offer the same effectiveness in treatment," MHA CEO Brian Peters said in a statement.

The shortage of cisplatin and carboplatin is linked to quality control issues at Intas Pharmaceuticals Limited, an India-based manufacturer that supplies U.S. distributor Accord Healthcare. That disruption in supply increased demand on other manufacturers that were unable to keep up, lawmakers said.

The MHA said it supports several measures to ease the impact of drug shortages, including relaxing prior authorization requirements from health insurers for alternative therapies so they can be more widely used, and creating an early warning system to help avoid or minimize drug shortages.

The association also endorsed removing regulatory obstacles that manufacturers and the FDA encounter in an effort to mitigate the shortages and permit drug imports.

mburke@detroitnews.com