FDA to allow imports of cancer drug from China amid ongoing shortage
CNN
In order to increase supply in the face of an ongoing shortage, the US Food and Drug Administration has partnered with Chinese drugmaker Qilu Pharmaceutical.
Apotex, a Canadian pharmaceutical company, will temporarily distribute injectable medications in vials of 50 milligrams. Health care providers can order it starting on Tuesday.
According to the National Cancer Institute, 10% to 20% all cancer patients are prescribed Cisplatin or other platinum-based medications. Cisplatin is a highly effective treatment for testicular cancer, with a cure rate exceeding 90%. Cisplatin is also used to treat bladder, cervical and ovarian cancers, as well as lung, gastric and breast cancers.
As the US struggles with a record number of drug shortages, cancer treatments are the most affected. According to the University of Utah Drug Information Service, as of the end of march, there were about 20 chemotherapy drugs in active shortage. This is the fifth highest number of drug categories.
In a hearing held last month to discuss the shortages of certain drugs, legislators criticized FDA for its lack of inspections. This was especially true with regard to international facilities. FDA Commissioner Robert Califf, however, said that the FDA is doing all it can to address the shortages despite the fact that economic factors are outside its jurisdiction.
Califf tweeted late Friday that the FDA "recognizes the importance" of a safe, stable supply of drugs in oncology. This is especially true for those that are used to treat or prolong life. We've taken measures to temporarily import certain foreign-approved versions cisplatin from FDA-registered facility and used regulatory discretion to continue supply of other carboplatin and cisplatin product.
In these situations, the FDA will carefully evaluate product quality and demand that companies take certain steps to ensure patient safety. We will continue to do everything we can within our power to assist the companies that produce and distribute these drugs in meeting all patient demands for oncology drugs that are affected by shortages.
According to Dr. Amanda Fader of the Johns Hopkins School of Medicine on Friday, the severe shortage of carboplatin and cisplatin, "the chemotherapy backbone," is affecting thousands of US patients.
She said that substitutions were sometimes necessary. In many cases, drug substitutes will be just as effective when it comes to treatment response. These drugs can have worse side effects or require a different dosage schedule that takes two to three time longer to administer.
Fader stated that imports of foreign medicines have helped in cases similar to this before. In a decade, the FDA permitted foreign companies to import Doxil during a prolonged shortage of the chemotherapy drug. The FDA must approve the drugs after they have passed the same inspections and requirements. This process can take a while.