The MHA has been in frequent contact with members of the Michigan Congressional delegation since the association was made aware of shortages of the chemotherapy drugs carboplatin and cisplatin. Representatives Debbie Dingell (D-Ann Arbor) and Tim Walberg (R-Tipton) led the Michigan delegation in sending a bipartisan letter May 24 to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf to urge the FDA to take immediate action to mitigate the effects of the nationwide shortage of chemotherapy medications. Every member of the Michigan delegation signed on to the letter.
U.S. Senators Gary Peters (D-Bloomfield Twp.) and Debbie Stabenow (D-Lansing), along with U.S. Representative Elissa Slotkin (D-Lansing), wrote a separate letter to Dr. Califf asking that the FDA do everything in its power to mitigate the dire shortage of cancer drugs that has reached crisis levels in recent months.
The office of Sen. Peters also provided the following information to the MHA during the week of May 22 regarding the shortages.
- The shortages for each drug are caused by the manufacturer Accord deciding to place production on hold, pending further assessments. Four other manufacturers of the drugs have not been able to fill the supply gap left by Accord.
- The FDA has continued to work with Accord on prioritization of their assessments for product release and cisplatin and carboplatin are prioritized for release. Cisplatin is now being released following the assessment and supplies are making their way to hospitals and cancer centers. Meanwhile, carboplatin is planned to be released soon.
- The FDA is also working with the other four manufacturers to increase supply and are offering expedited review of anything needed to increase supply, such as additional manufacturing lines, facilities and suppliers.
- The FDA is requesting the manufacturers provide data to extend expiration dating for lots on the market that remain in distribution but are nearing expiration. Once received, the FDA will post the drug, old lot number and new lot number on the Extended Use database on the Drug Shortage website.
- In addition, the FDA is exploring temporary importation to meet patient needs during the shortage. During temporary import, the FDA evaluates the overseas product attributes, as well as the manufacturing facilities, to ensure no risks exist for US patients.
Updates for both cisplatin and carboplatin are being provided by the FDA on the drug’s FDA Drug Shortage webpages.
Members with questions may contact Renee Smiddy with the MHA.